7.2Campylobacter

Bibliographic informationStudy type and evidence levelStudy detailsPatient characteristicsIntervention and comparisonOutcome measures, follow-up and effect sizeComments
Robins-Browne 1983a152
Location : South Africa
Study Type RCT

Evidence Level 1−
Total number of participants
n = 25
C jejuni only
n = 8

Randomised into two treatment arms

Group 1
Intervention :
Erythromycin
All participants
n = 11
C jejuni infection only
n = 4

Group 2
Intervention :
Placebo
All participants
n = 14
C jejuni infection only
n = 4
Inclusion criteria:
Children aged 1–24 months admitted to hospital with a history of diarrhoea of duration <96 hours, who had received no antimicrobial therapy for this illness.

Confirmation of C jejuni and any other infection from microscopic and culture examination of stool samples.

Exclusion criteria :
No details

Withdrawal criteria :
No details
Comparison

Erythromycin vs placebo

Intervention details:

Group 1:
Erythromycin ethylsuccinate oral suspension, 40 mg/kg per day in divided doses for 5 days

Group 2:
Placebo oral suspension
Follow up
Daily examination for 7 days

Outcome measures:

Mean duration of abnormal stool frequency

All participants
Group 1 = 0.77+−0.47 days
Group 2 = 1.57+−1.59 days
P = NS

C jejuni only
Group 1 = 0.8+−0.5 days
Group 2 = 1.8+−2.5 days
P = NS

Mean duration of abnormal stool consistency

All participants
Group 1 = 5.27+−1.68 d
Group 2 = 5.79+−1.25 d
P = NS

C jejuni only
Group 1 = 5.3+−1.7 days
Group 2 = 6.0+−1.2 days
P = NS

Mean duration of vomiting

All participants
Group 1 = 3.5+−0.71 d
Group 2 = 3.8+−1.3 d
P = NS

C jejuni only
Group 1 = 0
Group 2 = 3.0 d

Mean duration of dehydration

All participants
Group 1 = 2.91+−1.81 d
Group 2 = 2.79+−1.97 d
P = NS

C jejuni only
Group 1 = 1.8+−1.5 days
Group 2 = 2.3+−2.5 days
P = NS

Fever

All participants
Group 1 = 3.33+−1.63 d
Group 2 = 3.6+−1.52 d
P = NS

C jejuni only
Group 1 = 2.0 d
Group 2 = 0 d
Funding :
South African MRC
University of Natal, Abbott Laboratories

Applicable to UK

Baseline comparability
Similar for age, sex, nutritional status, duration of illness, extent of dehydration

Allocation concealment :
Yes, pharmacy controlled

Sequence generation :
Code used

Blinding of outcome assessors :
Yes

Loss to follow up
1/26 voluntarily withdrew

Intention to treat analysis :
Not stated

Power calculation :
None stated
Pai 1983146

Location : Canada
Study Type
RCT

Evidence Level 1+
Total number of participants

N =32, results for 27 participants with complete data presented

Randomised into two treatment arms

Group 1
Intervention :
Erythromycin
n = 15

Group 2
Intervention :
No treatment
n = 12
Inclusion criteria:

Children up to 12 years with symptomatic enteritis and their household contacts.

Recruitment when stool samples from children had positive culture of erythromycin sensitive campylobacter.

Exclusion criteria :
Presence of other enteric pathogens in the stool, antibiotic therapy in previous 2 weeks and patients with a positive culture who were no longer symptomatic

Withdrawal criteria :
Not stated
Comparison

Erythromycin vs no treatment

Intervention details:

Group 1:
Erythromycin ethylsuccinate oral suspension, 40 mg/kg per day every 6 hours for 7 days

Group 2:
No treatment
Follow up

All participants contacted until all of the household had three consecutive negative (weekly) stool samples

Clinical symptoms assessed and reported daily by parent on telephone

Outcome measures:

Mean no of days with diarrhoea

Group 1 = 3.2 +/− 1.7
Group 2 = 3.8 +/− 4.0

WMD −0.60 [95% CI −3.02–1.82] P = 0.63

Range of no of days with diarrhoea

Group 1 = 1–6
Group 2 = 1–15

Mean no of days until first negative culture

Group 1 = 2.0 +−1.3
Group 2 = 16.8 +−12.5
P < 0.01
Funding :

Applicable to UK

Baseline comparability
Similar for age, sex, symptoms (diarrhoea, bloody diarrhoea, fever, vomiting), days ill prior to study entry.

Allocation concealment :
Not stated

Sequence generation :
Not stated

Blinding of outcome assessors:
No

Loss to follow up
5/32 participants had incomplete data

Intention to treat analysis :
No details

Power calculation :
Not stated
Salazar-Lindo 1986147

Location : Peru
Study Type
RCT

Evidence Level 1+
Total number of participants
n = 30

30 participants had C. jejuni positive stool culture

2/30 had concurrent Shigella infection

Randomised into two treatment arms

Group 1
Intervention :
Erythromycin
n = 14

Group 2
Intervention :
Placebo
n = 10
Inclusion criteria:

Children aged 3–60 months brought as outpatient for treatment of acute diarrhoea

Five or more loose stools per day with mucous and gross blood or PMN leucocytes for no longer than 5 days, no antibiotic treatment for 7 days, no other illness necessitating antibiotics

Exclusion criteria :

Clinical signs of dehydration, separate episode of diarrhoea during 2 weeks prior to coming to hospital, weight/height ratio <3rd percentile. Concurrent Campylobacter and Shigella infection

Withdrawal criteria :
Not stated

Confirmation of Campylobacter by stool culture. Confirmation received after randomisation.

If treatment failed, co-trimoxazole given as therapy for dysentery.
Comparison

Intervention details:

Group 1:
Erythromycin ethylsuccinate oral suspension, 50 mg/kg per day in 4 doses for 5 days

Group 2:
Placebo oral suspension
Follow up

Daily stool cultures (except Sundays holidays and daily reporting of symptoms by parents for a period of 5 days

Outcome measures:

Mean duration of diarrhoea

Group 1 = 2.4+−0.4 days
Group 2 = 4.2+−0.3 days
P < 0.01

Number patients with normal stools at 5 days
Group 1 = 13/14
Group 2 = 5/10
P < 0.02

Mean days to last positive stool culture
Group 1 = 0.5+−0.3 days
Range 0–5
Group 2 = 2.2+−0.6 days
Range 0–5
P < 0.01

Number patients with positive stool culture at 5 days
Group 1 = 1/11
Group 2 = 3/5
P < 0.05
Funding :
Abbott Laboratories Nestec Ltd

Applicable to UK

Baseline comparability
Similar for age, sex, weight/length ratio, diarrhoea symptoms, fever, vomiting, infections concurrent with Campylobacter

Allocation concealment :
Pharmacy controlled

Sequence generation :
Pharmacy controlled

Blinding of outcome assessors :
Yes

Loss to follow up
4/30 (two from each group)

Intention to treat analysis :
Partly

Power calculation :
Not stated

From: Evidence tables

Cover of Diarrhoea and Vomiting Caused by Gastroenteritis
Diarrhoea and Vomiting Caused by Gastroenteritis: Diagnosis, Assessment and Management in Children Younger than 5 Years.
NICE Clinical Guidelines, No. 84.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2009 Apr.
Copyright © 2009, National Collaborating Centre for Women’s and Children’s Health.

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