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Published on: April 5, 2017
Treatment outcomes and safety in children with rifampicin-resistant TB
E Lopez-Varela1, A J Garcia-Prats2, J A Seddon3
1Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa, ISGlobal, Barcelona Centre for International Health Research (CRESIB), Hospital Clínic - Universidad de Barcelona, Barcelona, Spain.
Insights
Treatment for drug-resistant tuberculosis (TB) in children showed excellent outcomes. Most children responded well, with few severe side effects, providing data for new treatment regimens.
Area of Science:
- Pediatric Infectious Diseases
- Mycobacterial Infections
- Public Health
Background:
- Rifampicin-resistant tuberculosis (RR-TB) treatment in children is evolving.
- Newer regimens necessitate comparison with historical treatment outcomes and safety data.
- Understanding outcomes in vulnerable pediatric populations is crucial.
Purpose of the Study:
- To evaluate the safety and effectiveness of routine RR-TB treatment in children.
- To establish a reference cohort for future studies on novel TB regimens.
- To assess adverse events associated with current RR-TB treatment protocols in pediatric patients.
Main Methods:
- Prospective observational cohort study of children undergoing RR-TB treatment.
- Enrolled children from 2011-2015 in Cape Town, South Africa.
- Monitored children for safety, treatment response, and overall outcomes.
Main Results:
- 91.5% of children achieved favorable TB treatment outcomes.
- Median time to culture conversion was 28.5 days in bacteriological confirmed cases.
- Hearing loss occurred in 8.5% of children receiving injectable drugs; 5.1% had other severe adverse events.
Conclusions:
- Excellent TB treatment outcomes were observed in this pediatric cohort, including those with severe TB and HIV.
- Severe adverse events were infrequent, with hearing loss being the most notable.
- This study offers valuable reference data for evaluating future shorter, injectable-sparing RR-TB regimens in children.
Abstract:
BACKGROUND: The treatment of rifampicin-resistant TB (RR-TB) in children is evolving rapidly. As newer regimens are introduced into routine care, it is vital to compare their outcome and safety with well-characterised clinical cohorts treated with historical regimens.METHODS: Study sample comprised a prospective observational cohort of children on routine RR-TB treatment, enrolled from 2011 to 2015 in Cape Town, South Africa. Children were followed for safety, treatment response and outcome.RESULTS: Of 136 children included, 27 (19.9%) were living with HIV and 48 (37.8%) had severe TB. The median time-to-culture conversion in children with bacteriological confirmation (n = 44) was 28.5 days (IQR 14.5-45). Overall, 118/129 (91.5%) had favourable TB treatment outcomes. Of 106 (77.9%) children who received an injectable drug, 9 (8.5%) developed hearing loss and 7/136 (5.1%) developed other Grade 3 or higher adverse events likely related to treatment.CONCLUSIONS: In this cohort with a substantial proportion of children with severe manifestations of TB and with HIV, TB treatment outcomes were excellent. Apart from hearing loss, few children developed severe adverse events related to treatment. This study provides robust reference data for future evaluation of shorter, injectable-sparing regimens.
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