Evidence map›Paper›PMID 40342012›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025

Treatment Outcomes With an Oral Short Course Regimen for Rifampicin-resistant Tuberculosis in a High HIV Prevalence, Programmatic Setting in South Africa.

Jacob A M Stadler, Johanna Kuhlin, Síle F Molloy, Nomfuneko Mtwa, Cindy Hayes, Gary Maartens, Robin Warren, Graeme Meintjes, Sean Wasserman

Erratum issuedAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Treatment Adherence With an Oral 9-Month Regimen for Rifampicin-Resistant Tuberculosis in South Africa.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Observational
  3. Observational
  4. Article
  5. Observational
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Jacob A M StadlerWellcome Discovery Research Platforms in Infection, Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0003-1704-5208
Johanna KuhlinWellcome Discovery Research Platforms in Infection, Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-3398-2421
Síle F MolloyInstitute for Infection and Immunity, City St George's, University of London, London, United Kingdom.ORCID 0000-0001-8847-2325
Nomfuneko MtwaDepartment of Health, Eastern Cape Province, South Africa.
Cindy HayesNational Health Laboratory Service, Port Elizabeth, South Africa.
Gary MaartensWellcome Discovery Research Platforms in Infection, Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0003-3080-6606
Robin WarrenDSI-NRF Centre of Excellence for Biomedical Tuberculosis Research/South African Medical Research Council Centre for Tuberculosis Research, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.ORCID 0000-0001-5741-7358
Graeme MeintjesWellcome Discovery Research Platforms in Infection, Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Sean WassermanWellcome Discovery Research Platforms in Infection, Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-3508-6719

Funding

PRESCIENT: A phase IIc, open-label, randomized controlled trial of ultra-short course bedaquiline, clofazimine, pyrazinamide and delamanid versus standard therapy for drug-susceptible tuberculosisU01AI170426 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI SERENA Patricia KOENIG, Sean Wasserman · 2022 to 2026
$5.9M
Bill & Melinda Gates FoundationNIAID NIH HHS U01 AI170426NIH HHS U01AI170426South African Medical Research Council MRC-RFA-SHIP 02-2018Swedish Heart-Lung Foundation 20220859Swedish Society of Medicine SLS-985976
6 · The paper itself

Abstract

backgroundBedaquiline-based oral short-course regimens (SCR) for rifampicin-resistant tuberculosis (RR-TB) are highly effective in clinical trials but outcomes in programmatic settings may be more modest. We evaluated clinical and bacteriological outcomes with a seven-drug, linezolid-containing SCR in a high-burden programmatic setting.

methodsThis prospective cohort study enrolled adults with newly diagnosed RR-TB who were started on the oral SCR in the Eastern Cape Province, South Africa. The primary outcome was World Health Organization-defined end-of-treatment success. Secondary outcomes were TB-free survival (composite of alive, absence of a positive Mycobacterium tuberculosis culture, and treatment completed or in care) at 18 months and time to sputum culture conversion (SCC).

resultsIn total, 248 participants were included, 173 (69.8%) of whom were human immunodeficiency virus (HIV) positive. Culture conversion by 90 days was 96.8% (median time to SCC: 29 days, 95% confidence interval [CI]: 27-31). Treatment success was 37.5% (93/248). Reasons for unsuccessful treatment included switching to individualised regimens (35.1%, 87/248), loss to follow-up (19.4%, 48/348), and death (8.1%, 20/248). At 18 months, 157 (63.3%) participants achieved TB-free survival, with a cumulative mortality of 21.6% (95% CI: 16.1-29.0). Baseline 3+ smear (adjusted odds ratio [aOR]: 3.38, 95% CI: 1.28-8.95), higher age (aOR: 1.05, 1.01-1.08), and lower albumin (aOR: 0.94, 0.88-0.99), but not HIV status, were associated with unfavourable outcome at 18 months.

conclusionsThe oral SCR performed poorly in a high-burden TB programme. Strategies to support the implementation of effective new regimens for RR-TB are needed to translate outcomes from clinical trials into practice.

Indexed as

Antitubercular AgentsHIV InfectionsRifampinTuberculosis, Multidrug-ResistantAdministration, OralAdultFemaleHumansLinezolidMaleMiddle AgedMycobacterium tuberculosisPrevalenceProspective StudiesSouth AfricaTreatment OutcomeAntitubercular AgentsLinezolidRifampindrug-resistant tuberculosisHIVoutcomesrifampicin-resistant tuberculosisshort oral regimen

Identifiers

PMID40342012
PMCPMC12596408

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.