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Clin Infect Dis. 2019 Feb 27. pii: ciz152. doi: 10.1093/cid/ciz152. [Epub ahead of print]

A moxifloxacin-based regimen for the treatment of recurrent drug-sensitive pulmonary tuberculosis: An open-label randomised controlled trial.

Author information

1
Centre for the AIDS Programme of Research in South Africa, Nelson R Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal.
2
Department of Pulmonology and Critical Care, Groote Schuur Hospital, University of Cape Town, Western Cape, South Africa.
3
South African Medical Research Council-CAPRISA HIV-TB Pathogenesis and Treatment Research Unit, Doris Duke Medical Research Institute, University of KwaZulu-Natal.

Abstract

BACKGROUND:

The substitution of moxifloxacin for ethambutol produced promising results for improved tuberculosis (TB) treatment outcomes.

METHOD:

We conducted an open-label randomized trial to test whether a moxifloxacin-containing treatment regimen was superior to the standard regimen for the treatment of recurrent TB. The primary and secondary outcomes were sputum culture conversion rate at the end of 8 weeks and the proportion of participants with a favourable outcome, respectively.

RESULTS:

We enrolled 196 participants; 69.9% were male and 70.4% were co-infected with HIV. There was no significant difference between the study groups in the proportion of patients achieving culture conversion at the end of 8 weeks [83.0% (Moxifloxacin) vs 78.5% (Control), p=0.463], however the median time to culture conversion was significantly shorter (6.0 weeks, IQR 4.0 - 8.3) in the moxifloxacin group than the control group (7.9 weeks, IQR 4.0- 11.4) (p=0.018). A favourable end-of-treatment outcome was reported in 86 participants (87.8%) in the moxifloxacin group and 93 participants (94.9%) in the control group, for an adjusted absolute risk difference of -5.5 (95% CI -13.8 to 2.8, p=0.193) percentage points. There was a significantly higher proportion of participants with grade 3 or 4 adverse events [43.9% (43/98) vs 25.5% (25/98), p=0.011] and serious adverse events [27.6% (27/98) vs 12.2% (12/98), p=0.012] in the moxifloxacin group.

CONCLUSION:

Replacement of ethambutol with moxifloxacin did not significantly improve culture conversion rates at the end of 8 weeks or treatment success, and was associated with a higher incidence of adverse events.

KEYWORDS:

Recurrent tuberculosis; moxifloxacin; treatment outcomes; tuberculosis

PMID:
30809633
DOI:
10.1093/cid/ciz152

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