Evidence map›Paper›PMID 41564894›Full record

Observational studyClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026

Pregnant Women With Multidrug-Resistant/Rifampicin-Resistant Tuberculosis and the All-Oral 6-Month Regimen: Experiences From a Patient Series in South Africa.

Marian Loveday, Emma Clarence, Sindisiwe Hlangu, Nalini Singh, Sunitha Chotoo, James C M Brust, Catriona Waitt, Richard Court, Jennifer Furin

Erratum issuedAbstract readObservational Study
In one paragraph

Observational study in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Marian LovedayHIV and Other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.ORCID 0000-0001-9205-9314
Emma ClarenceHIV and Other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.ORCID 0009-0006-1025-0494
Sindisiwe HlanguHIV and Other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.
Nalini SinghKing Dinuzulu Hospital Complex, Sydenham, Durban, South Africa.
Sunitha ChotooKing Dinuzulu Hospital Complex, Sydenham, Durban, South Africa.
James C M BrustDivisions of General Internal Medicine and Infectious Diseases, Montefiore Medical Center, Albert Einstein College of Medicine, NewYork, New York, USA.ORCID 0000-0003-3362-1818
Catriona WaittInfectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.ORCID 0000-0003-0134-5855
Richard CourtDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-7927-6506
Jennifer FurinDepartment of Global Health and Social Development, Harvard Medical School, Boston, Massachusetts, USA.

Funding

Mentoring of multidisciplinary global health research in tuberculosis and HIVK24AI155045 · NIAID · ALBERT EINSTEIN COLLEGE OF MEDICINE · PI BRUST, JAMES C M · 2020 to 2025
$889k
IMPILO: Investigating novel 6-Month regimens for RR-TB in Pregnancy and LactationR01AI183355 · NIAID · MEDICAL RESEARCH COUNCIL OF SOUTH AFRICA · PI Marian Loveday · 2024 to 2026
$386k
National Institute of Allergy and Infectious DiseasesNIAID NIH HHS K24 AI155045NIAID NIH HHS R01 AI183355NIH HHS R01AI183355South African Medical Research Council
6 · The paper itself

Abstract

backgroundThere is limited experience of the all-oral 6-month regimens containing bedaquiline, delamanid, linezolid, and levofloxacin or clofazimine (BDLLfx/BDLCfz) in pregnant women with multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR-TB). We report maternal treatment, pregnancy, and infant outcomes to 12 months of age in a cohort of pregnant women treated with these regimens.

methodsWe included pregnant women treated for MDR/RR-TB from September 2023 to January 2025 in KwaZulu-Natal, South Africa, in a prospective observational study. Outcomes were collected through ongoing record reviews. Infant clinical assessments were conducted at 6 weeks, 6 months, and 12 months.

resultsOf 25 pregnant women with MDR/RR-TB, 21 received BDLLfx/BDLCfz; 12 (57%) were diagnosed with human immunodeficiency virus. Although 10 of the 21 (48%) treated women developed anemia, 18 (86%) had favorable treatment outcomes. All 21 infants were born alive, with a median gestational age 39 weeks (interquartile range [IQR], 38-40 weeks) and median birth weight 3160 g (IQR, 2818-3308 g). Three women had unfavorable pregnancy outcomes, with infants born prematurely (2 with low birth weight and 1 who developed respiratory distress syndrome). Of the 18 infants evaluated at 12 months, 10 (56%) had possible or confirmed unfavorable outcomes. Two infants had confirmed congenital anomalies and 3 possible congenital anomalies, but only 1 had first-trimester drug exposure. One infant died, another was diagnosed with MDR/RR-TB and started on treatment, and 3 infants had signs/symptoms of tuberculosis, necessitating referral for care.

conclusionsThese limited data suggest that in pregnant women, the BDLLfx/BDLCfz regimens have improved treatment and pregnancy outcomes compared to prior regimens. However, there is a high prevalence of unfavorable infant outcomes.

Indexed as

Antitubercular AgentsPregnancy Complications, InfectiousTuberculosis, Multidrug-ResistantAdministration, OralAdultFemaleHumansInfantInfant, NewbornPregnancyPregnancy OutcomeProspective StudiesRifampinSouth AfricaTreatment OutcomeYoung AdultAntitubercular AgentsRifampinall-oral 6-month MDR/RR-TB regimendrug-resistanceoutcomestuberculosis

Identifiers

PMID41564894
PMCPMC13189674

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.