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Updated recommendations for the treatment of Neisseria gonorrhoeae, Chlamydia trachomatis and Treponema pallidum (syphilis), and new recommendations on syphilis testing and partner services [Internet]. Geneva: World Health Organization; 2024.

Cover of Updated recommendations for the treatment of Neisseria gonorrhoeae, Chlamydia trachomatis and Treponema pallidum (syphilis), and new recommendations on syphilis testing and partner services

Updated recommendations for the treatment of Neisseria gonorrhoeae, Chlamydia trachomatis and Treponema pallidum (syphilis), and new recommendations on syphilis testing and partner services [Internet].

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3Updated treatment recommendations

This section provides treatment recommendations and good practice statements for specific conditions caused by N. gonorrhoeae, C. trachomatis and T. pallidum. The recommendations for treating gonococcal and chlamydial infections (sections 3.1 and 3.2) apply to all adults and adolescents, including during pregnancy, and including people living with HIV and key populations (see Glossary). A separate recommendation on treating uncomplicated chlamydial infections applies specifically to pregnant and breastfeeding women. The updated treatment recommendations for syphilis infections (section 3.3) apply only to pregnant and breastfeeding women.

3.1. Treatment of gonococcal infections

The following recommendations apply to adults and adolescents, including during pregnancy, and including people living with HIV and key populations.

Good practice statement on treatment of gonococcal infections (updated 2023)

WHO recommends that national or local antimicrobial resistance data should determine the choice of therapy when available.

Recommendation on treatment of gonococcal infections (updated 2023)

For adults and adolescents (including pregnant women) with genital, anorectal and/or oropharyngeal gonococcal infections, WHO suggests:

  • ceftriaxone 1 g intramuscularly as a single dose.

If ceftriaxone is not available or refused, WHO suggests:

  • cefixime 800 mg orally and performing test of cure.

If test of cure is not possible or when oropharyngeal infection is diagnosed or is a potential concern, WHO suggests:

  • cefixime 800 mg orally plus azithromycin 2 g orally.

When resistance, allergy or availability of cephalosporins is a concern, WHO suggests one of the following options:

  • spectinomycin 2 g intramuscularly as a single dose plus azithromycin 2 g orally; or
  • gentamicin 240 mg intramuscularly as a single dose plus azithromycin 2 g orally.

Conditional recommendation, low certainty in evidence of effects

Remarks:

  • Ceftriaxone 1 g intramuscularly may be painful; discuss with the individual the option of using lidocaine as diluent with the injection.
  • Azithromycin 2 g may cause gastrointestinal side-effects, especially on an empty stomach. To reduce side-effects, consider azithromycin 1 g taken at 6- to 12-hour intervals.
  • Sexual abstinence, condom use and partner treatment should be discussed.
  • WHO guidance on surveillance of antimicrobial resistance in N. gonorrhoeae and test of cure is available (31).
  • Pregnant women should be closely monitored for adverse reactions (e.g. allergic reactions including anaphylactic shock, premature delivery and premature rupture of membranes).

3.1.1. Genital, anorectal and oropharyngeal gonococcal infections

Rationale for making the recommendations

The evidence for moderate benefits and negligible harm of higher doses of ceftriaxone and cefixime mainly comes from non-comparative studies conducted before changes in resistance, and therefore the certainty is low. Surveillance data indicate a possible decrease in resistance to ceftriaxone and cefixime in some countries and a possible increase in others, while they also indicate increasing resistance to azithromycin globally. Pharmacodynamic data suggest that ceftriaxone 1 g could eradicate most strains (except highly resistant strains causing oropharyngeal infections). Because evidence found fewer cures with cefixime (even at 800 mg), a test of cure could be performed to ensure cure, or – if not possible – combining therapy with a higher dose of azithromycin (2 g) may ensure cure. Therefore, the GDG increased the dose of ceftriaxone to 1 g without azithromycin; the dose of cefixime was increased to 800 mg (with or without azithromycin depending on whether a test of cure is performed), and the dose of spectinomycin and gentamicin were unchanged with the addition of azithromycin 2 g to ensure cure.

Summary of the evidence

Effects

Overall, the certainty of evidence for the effects of treatment on gonococcal infections is low, due to most studies not being recent, changes in antimicrobial resistance and small sample sizes in comparative studies. The evidence-to-decision framework in Web Annex A provides a detailed description of the evidence summarized below, with references. In the updated systematic review of the literature, there were 15 new studies (3 randomized controlled trials [RCTs] and 12 non-randomized and non-comparative studies) in addition to the 41 studies reviewed in 2016 (see Web Annex A). The studies primarily involved individuals with confirmed gonorrhoea. Higher doses of ceftriaxone or cefixime may result in slightly greater cure rates (1–3 percentage points more), but cefixime may provide fewer cures. Combining ceftriaxone with azithromycin (dual therapy) probably does not increase cures. Data from systematic reviews of the literature and from the WHO Gonococcal Antimicrobial Surveillance Programme (GASP) found that ceftriaxone resistance is increasing in most countries, except in Europe, where introducing a ceftriaxone 500 mg dose in 2013 and subsequently increasing to ceftriaxone 1 g was associated with a decrease in reported ceftriaxone resistance (6, 9, 12, 32). Treatment failure after use of ceftriaxone and azithromycin dual therapy is increasingly being reported globally, and there are indications that the determinants of ceftriaxone antimicrobial resistance are spreading. Pharmacodynamic data suggest that ceftriaxone 1 g could eradicate most strains except oropharyngeal infections caused by highly resistant strains. Providing ceftriaxone 1 g will cure most cases of gonorrhoea, thus delaying the emergence and spread of multi-drug resistance and particularly ceftriaxone resistance. The evidence was inconsistent regarding undesirable effects and did not show a pattern of greater adverse events with higher doses of ceftriaxone or cefixime. However, higher doses of intramuscular ceftriaxone may be more painful, and azithromycin 2 g can result in gastrointestinal side-effects, especially when taken on an empty stomach.

Values and preferences

Although no studies assessing patient values were found, the Guideline Development Group (GDG) agreed that reducing treatment failures to reduce the spread of N. gonorrhoeae and prevent resistant strains was more highly valued than reducing adverse effects. The GDG also noted that ceftriaxone 1 g intramuscularly is painful and potentially less acceptable, and some individuals may prefer to use lidocaine to mitigate the pain. To reduce the gastrointestinal side-effects, azithromycin can be taken in two divided doses at 6- to 12-hour intervals. In many countries, clinicians are already providing ceftriaxone 500 mg or 1 g, and ceftriaxone 1 g ampules are available in most countries.

Costs and feasibility

Evidence for cost-effectiveness was also compiled, but these models were unlikely to account for changing antimicrobial resistance. The cost differences between lower and higher doses of ceftriaxone or cefixime are likely to be negligible since the packages dispensed typically include higher/more doses than needed. Moreover, higher doses are already provided in many countries, indicating feasibility of use.

3.1.2. Gonococcal infections after treatment failure

Good practice statement on retreating gonococcal infections after treatment failure (new 2023)

For adults and adolescents (including pregnant women) with gonococcal infections for whom treatment has failed as evidenced by persistent symptoms or a positive test of gonococcal infection, WHO recommends that the possibility of reinfection or antimicrobial resistance be considered to determine the choice of therapy.

Recommendation on retreating gonococcal infections after treatment failure (updated 2023)

If treatment failure occurred after a non-WHO-recommended treatment, WHO suggests retreating with a WHO-recommended therapy.

If reinfection is suspected, WHO suggests retreating with a WHO-recommended therapy, reinforcing the need for sexual abstinence, condom use and partner treatment.

If treatment failure occurred and antimicrobial susceptibility testing data are available, WHO suggests retreating according to susceptibility profile.

If treatment failure occurred after a WHO-recommended therapy and reinfection is assessed to be unlikely, WHO suggests retreating with a regimen not used previously from one of the following options and performing test of cure:

  • ceftriaxone 1 g intramuscularly as a single dose plus azithromycin 2 g orally, only if ceftriaxone was not used previously;
  • spectinomycin 2 g intramuscularly as a single dose plus azithromycin 2 g orally; or
  • gentamicin 240 mg intramuscularly as a single dose plus azithromycin 2 g orally.

Conditional recommendation, very low certainty in evidence of effects

Remark:

  • Retreatment should not be delayed. If an individual does not respond to these treatment failure recommendations, refer the individual to a specialist for further assessment and management.

Rationale for making the recommendations

As indicated in the summary of the evidence for the recommendations for treatment of gonococcal infections (in section 3.1.1) and also in Web Annex A, azithromycin resistance is increasing, and doses higher than azithromycin 1 g may therefore be more effective. The GDG also agreed that adding azithromycin to treatment for men who have sex with men may delay the spread of ceftriaxone resistance. The GDG therefore agreed that treatment should be built on the recommendations for treating gonococcal infections, including ceftriaxone and alternative options, but that azithromycin 2 g should be added. In addition, these recommendations were edited to align with the recommendations for the initial treatment of genital, anorectal and oropharyngeal gonococcal infections (in section 3.1.1).

Summary of the evidence

Effects

Overall, the certainty of the evidence in effects is very low. No new evidence was found with which to update the literature review for this question, and therefore the same evidence used to develop the 2016 recommendations was used. There were 34 randomized and non-randomized studies that evaluated a single treatment or many treatments and then reported on retreatment of individual cases of treatment failure. No studies specifically recruited people who had treatment failure. Most studies gave reports regarding cases of treatment failure or reinfection (often not distinguished from each other). These studies also reported the medicine used for initial treatment and the medicine used for retreatment and sometimes reported whether or not the case was cured. Cure rates for different medicines were not consistent across the studies. Case reports of treatment failure indicated cure was achieved by increasing dosages of ceftriaxone to 1 g and azithromycin to 2 g.

3.2. Treatment of chlamydial infections

The following recommendations apply to adults and adolescents, including people living with HIV and key populations. Separate recommendations are provided specifically for pregnant and breastfeeding women.

3.2.1. Uncomplicated chlamydial infections (genital, anorectal and oropharyngeal)

Recommendation on treatment of chlamydial infections (updated 2023)

For adults and adolescents with uncomplicated chlamydial infections (genital, anorectal and/or oropharyngeal), WHO suggests:

  • doxycycline 100 mg orally twice a day for 7 days.

If doxycycline is not available or adherence to multiple doses is a serious concern, WHO suggests:

  • azithromycin 1 g orally as a single dose.

If doxycycline and azithromycin are not available, WHO suggests one of the following options:

  • erythromycin 500 mg orally four times a day for 7 days;
  • ofloxacin 200–400 mg orally twice a day for 7 days; or
  • tetracycline 500 mg orally four times a day for 7 days.

Conditional recommendation, moderate certainty in evidence of effects

Remarks:

  • Doxycycline extended release (ER) may be an alternative to twice daily dosing of doxycycline, but the high cost may prohibit its use.
  • If using an alternative treatment for gonococcal infection (cefixime 800 mg plus azithromycin 2 g), maintain the 2 g dosage of azithromycin to cover chlamydial infection.
  • Note that doxycycline, tetracycline and ofloxacin are contraindicated in pregnant and breastfeeding women (see separate recommendations for pregnant and breastfeeding women).

Recommendations on treatment of chlamydial infections in pregnant and breastfeeding women (edited 2023)

For pregnant and breastfeeding women with uncomplicated chlamydial infection, WHO recommends:

  • azithromycin 1 g orally as a single dose.

Strong recommendation, moderate certainty in evidence of effects

When azithromycin is not available, WHO suggests one of the following options:

  • amoxicillin 500 mg orally three times a day for 7 days; or
  • erythromycin 500 mg orally four times a day for 7 days.

Conditional recommendation, low certainty in evidence of effects

Remark:

  • If using an alternative treatment for gonococcal infection (cefixime 800 mg plus azithromycin 2 g), maintain the 2 g dosage of azithromycin to cover chlamydial infection.

Rationale for making the recommendations

While it was generally agreed that use of either medicine is feasible, the GDG emphasized the need for special consideration in addressing the concerns of adolescent girls and other vulnerable populations. Overall, the recommendation for the primary treatment for adults and adolescents for uncomplicated genital chlamydial infections was changed to doxycycline instead of azithromycin, making it similar to recommendations for anorectal or oropharyngeal chlamydial infections, and therefore all recommendations were combined.

The GDG did not identify the recommendation for pregnant and breastfeeding women as needing an update. In 2017, an updated Cochrane systematic review was published on this topic with a literature search including publications up to June 2017 and no new RCTs comparing different medications were found at that time. The GDG agreed that the recommendations for pregnant and breastfeeding women did not need to be revised but instead could be edited to align with the format and language of the recommendation for adults and adolescents, and therefore the edited recommendation is presented here.

Summary of the evidence

Effects

Overall, the certainty of evidence in adults and adolescents for the effects of azithromycin compared with doxycycline for chlamydial infections is moderate. A Cochrane systematic review was updated to include evidence published up to August 2023 (33), but no additional studies were found that met the eligibility criteria (Web Annex B). The 11 RCTs found similar cure rates with both medicines (92.5% with azithromycin and 94.4% with doxycycline) and similar rates of adverse events (18% with azithromycin and 21.8% with doxycycline).

Although, there are minor differences between benefits and harms of the different medication regimens, the GDG agreed that there may be greater harm when using azithromycin. There is increasing resistance in N. gonorrhoeae to azithromycin (see section 3.1). Continued use of azithromycin will select for strains with increased resistance. A systematic review of 59 studies found that the prevalence of mutations linked to macrolide resistance rose from 10% to 51% between the years prior to 2010 and the years 2016–2017 in Mycoplasma genitalium (34). There are limited treatment options for M. genitalium, therefore there is a need to conserve the use of azithromycin for treatment of M. genitalium. Moreover, research has shown that doxycycline may have the added benefit of reducing the bacterial load of M. genitalium before administering azithromycin (35).

Costs, feasibility and equity

Estimations of costs were based on dosing and pre-packaging, which may vary across countries, and cost-effectiveness likely depends on the prevalence of chlamydia. Equity issues in treatment distribution were explored, with some studies pointing to gender-related treatment disparities. A systematic review found that simpler medication regimens (e.g. single-dose azithromycin) may improve adherence (36). However, a comparison of studies indicates similar cure rates between the azithromycin and doxycycline, even in cases of potential non-adherence. The importance of sexual abstinence during treatment to prevent reinfection was noted, particularly for azithromycin (which is a single-dose treatment); however, evidence supporting this is lacking. In summary, although both medication regimens have similar costs, and are acceptable and feasible, the GDG agreed that the benefits of doxycycline outweigh the benefits of azithromycin for chlamydia treatment, when considering the growing resistance to azithromycin.

3.3. Treatment of Treponema pallidum (syphilis) during pregnancy

The following recommendations apply to pregnant women, and differ based on the duration of infection. This includes early syphilis (primary, secondary and early latent syphilis of not more than two years’ duration), late syphilis (late latent and tertiary syphilis of more than two years’ duration without evidence of treponemal infection) or unknown duration of syphilis infection.

3.3.1. Syphilis (early and late) in pregnant women

Recommendations for treatment of early syphilis in pregnant women (updated 2023)

In pregnant women with early syphilis, WHO recommends:

  • benzathine penicillin G 2.4 million units once intramuscularly.

Strong recommendation, very low certainty in evidence of effects

If benzathine penicillin is not available, WHO suggests:

  • procaine penicillin 1.2 million units intramuscularly once daily for 10 days.

In rare situations when benzathine or procaine penicillin cannot be used (e.g. due to confirmed penicillin allergy, which occurs in less than 3% of the population, and where penicillin desensitization is not possible) or are not available (e.g. due to stock-outs), WHO suggests one of the following options with caution and enhanced follow-up:

  • ceftriaxone 1 g intramuscularly once daily for 10–14 days; or
  • erythromycin 500 mg orally four times daily for 14 days.

Conditional recommendation, very low certainty in evidence of effects

Remarks:

  • If the stage of syphilis is unknown, follow recommendations for pregnant women with late syphilis.
  • Although erythromycin treats the pregnant woman, it does not cross the placental barrier completely and as a result the fetus is not treated. It is therefore necessary to treat the newborn infant soon after delivery (see recommendations in the WHO guidelines referring to congenital syphilis [15, 23]).
  • Doxycycline is contraindicated during pregnancy.

Recommendations for treatment of late syphilis or unknown duration of infection in pregnant women (updated 2023)

In pregnant women with late syphilis or an unknown duration of infection, WHO recommends:

  • benzathine penicillin G 2.4 million units intramuscularly once weekly for three consecutive weeks.

Strong recommendation, very low certainty in evidence of effects

Remark:

  • The interval between consecutive doses of benzathine penicillin G should not exceed 14 days.

If benzathine penicillin is not available, WHO suggests:

  • procaine penicillin 1.2 million units intramuscularly once daily for 20 days.

In rare situations when benzathine or procaine penicillin cannot be used (e.g. due to confirmed penicillin allergy, which occurs in less than 3% of the population, and where penicillin desensitization is not possible) or are not available (e.g. due to stock-outs), WHO suggests using, with caution and enhanced follow-up:

  • erythromycin 500 mg orally four times daily for 30 days.

Conditional recommendation, very low certainty in evidence of effects

Remarks:

  • Although erythromycin treats the pregnant woman, it does not cross the placental barrier completely and as a result the fetus is not treated. It is therefore necessary to treat the newborn infant soon after delivery (see recommendations in the WHO guidelines referring to congenital syphilis [15, 23]).
  • Doxycycline is contraindicated during pregnancy.

Rationale for making the recommendations

Penicillin continues to be the treatment with the greatest benefits compared with other antibiotics used for syphilis during pregnancy, and while there is little data for azithromycin the available data indicate that this treatment has the greatest potential for harm. There continue to be concerns about penicillin allergy, but it is likely that fewer than 3% of pregnant women are allergic to penicillin. The GDG therefore emphasized the need for increased public awareness about the low risk of penicillin allergy and that alternatives only rarely need to be used. Overall, the recommendations for penicillin use were not changed, but edits were made to delete azithromycin as an alternative and to emphasize the low risk of penicillin allergy.

Summary of the evidence

Effects

Overall, the certainty of evidence for the effects of treatment for syphilis during pregnancy is very low. The evidence-to-decision framework in Web Annex C provides a detailed description of the evidence summarized below, and includes all the references. Since the systematic review was conducted for the previous WHO treatment guidelines published in 2016, six non-randomized comparative studies comparing benzathine penicillin G with other antibiotics, two non-randomized trials comparing amoxicillin versus azithromycin, and three single-arm studies of non-penicillin antibiotics have been published (Web Annex C). As most studies did not report whether pregnant women had early or late syphilis, the evidence from these studies could not be separated for analysis as the basis for making the recommendations. The majority of the data (representing over 5000 participants) are from studies assessing penicillin and prevention of transmission of syphilis to babies, with reported effectiveness ranging from 96% to 100%. There is less data for erythromycin (about 70 participants) and ceftriaxone (about 30 participants), showing 96% and 70% effectiveness at preventing transmission, respectively. There is a very small amount of data for the use of azithromycin: in all five participants vertical transmission occurred, which may be because azithromycin does not cross the placental barrier. Adverse events may also be similar across medication regimens, although azithromycin likely results in greater adverse events. While both benzathine penicillin G (benzathine benzylpenicillin) and procaine penicillin (procaine benzylpenicillin) are categorized as “Access” on the WHO AWaRe list, the alternative treatments, such as azithromycin, are typically categorized as “Watch” (see Table 1.1 in section 1.6) (19, 20).

Concerns were raised about penicillin allergy, but a review found that while allergic responses are often reported (ranging from 6% to 25% across various treatment populations), only a small proportion of pregnant women, or indeed of people in general (likely less than 3%), truly has a penicillin allergy (37). In the absence of benzathine penicillin G, use procaine penicillin; this would provide greater benefits than other antibiotics since it can cross both the placental and blood–brain barriers.

Costs, feasibility and equity

Costs and feasibility are probably similar across medication regimens. Estimates of the costs of both medicines were based on the UNICEF Supply Catalogue and judged to be similar (38). Three studies explored equity issues in different contexts, including barriers to immediate treatment due to lack of awareness and concerns about adverse reactions.

3.4. Implementation considerations

3.4.1. Adapting, implementing and monitoring

These guidelines provide recommendations for treatment of gonorrhoea, chlamydia and syphilis based on the best available evidence at the time of compilation. However, the epidemiology and the patterns of AMR vary geographically and need to be monitored, in particular for N. gonorrhoeae. In areas lacking local, national or regional data as a basis for adaptation, the recommendations in these guidelines can be adopted as presented since they have been assessed globally before being included in these guidelines and were developed with a view to being applicable to most settings.

When the guidelines are adapted for national use, the STI medication regimens that are included should have an efficacy of at least 95% and should also meet as many of the other criteria listed in Box 3.1 as possible. The selected medicines also need to be locally available, and the competencies and experience of local health workers should be considered.

Box 3.1Criteria for selecting medicines for treating STIs to include in national guidelines

  • High efficacy (at least 95% cure rate)
  • High quality (potent active ingredient)
  • Low cost
  • Low toxicity levels
  • Organism resistance unlikely to develop or likely to be delayed
  • Single-dose regimen
  • Oral administration
  • Not contraindicated for pregnant or lactating women

Appropriate medicines should also be included in national lists of essential medicines.

3.4.2. Identifying and procuring STI Medicines

Identifying the medicines that will be recommended as first-line treatment for STIs is important but so are the estimated quantities of the medicines that will be required. Quantifying medicine needs is an important part of estimating costs, to reconcile financial requirements with the available budget. Budgeting appropriately for medicines is critical. If the national health ministry does not provide medicines without user charges and the people who need the medicines cannot afford them, then there will essentially be no way to curtail the spread of infection and the occurrence of complications, which put more strain on the health system and national economy. Decision-makers, politicians and fiscal controllers at the national level should therefore understand the need to subsidize STI medicines.

Estimation of quantities is also key information as a basis for placing advance orders of medicines, with a view to minimizing the unit and freight costs. Estimating the quantity of medicines needed requires reviewing the recommended medicines, their unit prices, the quantity required per treatment and the epidemiological information on the prevalence of infection. Medicine needs can be estimated by multiplying the estimated number of cases by the average quantity of medicine required for treating one case. These figures can be derived from health centres providing care but must be verified to avoid waste caused by excessive ordering (considering the limitations of shelf life and storage requirements).

Low-cost STI medicines can be obtained through international vendors of generic products and non-profit organizations with procurement schemes such as UNICEF, UNFPA and the United Nations High Commissioner for Refugees (UNHCR). In addition, through joint medicine procurement schemes, national programmes from two or more countries can agree to jointly procure medicines, thus reducing the overall costs by sharing the overhead costs and taking advantage of discounts for purchasing in bulk.

Placing STI medicines on national lists of essential medicines increases the likelihood of achieving a supply of these medicines at low cost.

3.4.3. STI services for key populations

Adaptation and implementation of these guidelines should be accompanied by efforts to promote and protect the human rights of people who need services for STI care. This includes ensuring that stigma and discrimination are prevented in providing such services, while promoting gender equity, and ensuring that the use of services is voluntary. As key populations are disproportionately affected by STIs, it is critical to increase access to STI services, including treatment for specific STIs, for people living with HIV and key populations. Recommendations and guidance are provided in WHO’s 2022 Consolidated guidelines on HIV, viral hepatitis and STI prevention, diagnosis, treatment and care for key populations (17). In addition, the following WHO guidance documents provide additional implementation considerations for increasing access to and effectively delivering STI services for key populations.

  • Implementing comprehensive HIV and STI programmes with sex workers: practical approaches from collaborative interventions (39)
  • Implementing comprehensive HIV and STI programmes with men who have sex with men: practical guidance for collaborative interventions (40)
  • Implementing comprehensive HIV and STI programmes with transgender people: practical guidance for collaborative interventions (41)
  • Implementing comprehensive HIV and HCV programmes with people who inject drugs: practical guidance for collaborative interventions (42).

3.5. Research needs

3.5.1. Research needs relating to treatment for gonococcal infections

Although surveillance data should be collected – including break points for resistance, frequency of collection, number of isolates and interpretation of local data – research on current and new medicine options is needed for genital, anorectal and oropharyngeal infections. This research is essential given the increasing antimicrobial resistance (AMR) to currently recommended treatments. Appropriately designed RCTs should be conducted on new medicine options, dual therapy and other alternatives (e.g. gentamicin). Specifically, studies should compare different combinations of dual therapy (e.g. combinations of gentamicin, ceftriaxone, cefixime, zoliflodacin, gemifloxacin or azithromycin), and should evaluate how dual therapy as the first line of treatment affects decreasing resistance rates to ceftriaxone and how dual therapy influences the emergence of resistance.

Continued surveillance and trials are necessary to monitor and investigate resistance to ceftriaxone, cefixime, azithromycin, doxycycline and other treatments for N. gonorrhoeae. Trials should include both men and women, and members of key populations. In addition to commonly reported outcomes (e.g. cure and side-effects), other important outcomes should be evaluated, including transmission of gonorrhoea to partners, HIV transmission and acquisition, quality of life, cost–effectiveness (including an assessment of the cost of resistance) and gonorrhoea AMR in vitro.

Treatment failure has been poorly researched. Although recruiting an entire study population who have all experienced treatment failure is difficult, studies that follow up with patients who have had treatment failure should improve the reporting of results. Studies should distinguish between cases of treatment failure and reinfection and should report the first treatment, the follow-up treatment and the outcome. Studies should also explore and report the susceptibility of the organism for those who have experienced treatment failure.

Low-cost point-of-care tests to diagnose gonorrhoea and to determine antibiotic susceptibility are needed to ensure good antibiotic stewardship that conserves treatment options for those with confirmed gonorrhoea and delays the emergence of resistance. Studies on molecular AMR determinants should be pursued to inform the development of antimicrobial susceptibility testing in N. gonorrhoeae to inform targeted treatment.

There is little research on the risk of resistance to medicines that are currently available for treating ophthalmia neonatorum. The state of resistance to the medicines should be explored, and it should be established whether these organisms would be killed by ocular prophylaxis despite resistant strains being present. The prevalence of gonococcal ophthalmia in newborns should be determined given the high prevalence of maternal gonorrhoea in some settings.

There is very little research on the values people place on outcomes such as cure, burden of disease, reducing future antibiotic resistance or risk of transmission. There is also little research specifically on people with gonococcal infections and their preferences for treatments, especially their preference for injection versus oral administration of medicine. Additional studies are needed to evaluate the impacts of intramuscular injections of ceftriaxone 1 g on acceptability of treatment.

3.5.2. Research needs relating to treatment for chlamydial infections

For chlamydial infections, the potential for resistance to doxycycline, azithromycin and other treatment options should be investigated further as additional studies are needed for monitoring purposes. RCTs are needed which compare these treatments and different dosages, while assessing clinical and microbiological cure, complications, side-effects (including allergy, toxicity and gastrointestinal effects), compliance, quality of life, and implications for HIV transmission and acquisition, as well as partner transmission of chlamydia. The outcomes should be assessed in both men and women, and in key populations.

Further research is also needed in pregnant women, comparing treatment options and the recommended dosages. Although these recommended medicines are generally safe to use during pregnancy, monitoring and analysis of maternal and fetal complications (e.g. adverse pregnancy outcomes and fetal defects) arising from the use of these treatments for STIs and other infections are important to inform future updates to recommendations. Cost and treatment acceptability should also be assessed.

3.5.3. Research needs relating to treatment for syphilis in pregnant women

An urgent need exists to develop a new treatment for syphilis during pregnancy, preferably an effective short-term orally administered course. Such treatment should have the capacity to cross the blood–brain and placental barriers, to prevent vertical transmission of syphilis (congenital syphilis).

Considering the requirement for health workers to administer benzathine penicillin G and related penicillins via injection, in addition to effective oral alternatives, research should explore the safety of self-injection. Dosage considerations for late syphilis (e.g. single-dose options versus multiple doses) should also be studied to inform treatment recommendations.

Further research is needed in pregnant women, comparing treatment options and the recommended dosages. Although these recommended medicines are generally safe to use during pregnancy, monitoring and analysis of maternal and fetal complications (e.g. adverse pregnancy outcomes and fetal defects) arising from the use of these treatments for STIs and other infections are important to inform future updates to recommendations. Cost and treatment acceptability should also be assessed.

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