Evidence map›Paper›PMID 42312322›Full record

Trial reportClinical pharmacology and therapeutics2026

Preserved Spermatogenesis and Hormonal Function in Men Receiving a Pretomanid Regimen (BPaMZ) for Pulmonary Drug-Resistant Tuberculosis.

Pauline Howell, Antonio Lombardi, William Brumskine, Lali Mikiashvili, Kim Boekelheide, Joanna Moreira, Alda Holsta, Matthew Betteridge, Lindsay Thompson, Angela Crook and 4 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Clinical pharmacology and therapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Pauline HowellClinical Health Research Unit (CHRU), Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.ORCID 0000-0002-5635-3134
Antonio LombardiTB Alliance, New York, New York, USA.ORCID 0009-0001-7383-2495
William BrumskineThe Aurum Institute NPC, Rustenburg, South Africa.ORCID 0000-0002-1092-9919
Lali MikiashviliNational Center for Tuberculosis and Lung Disease, Tbilisi, Georgia.ORCID 0000-0002-9569-7060
Kim BoekelheideBrown University, Providence, Rhode Island, USA.ORCID 0000-0003-4564-8057
Joanna MoreiraTB Alliance, New York, New York, USA.
Alda HolstaRho, Riga, Latvia.
Matthew BetteridgeTB Alliance, New York, New York, USA.
Lindsay ThompsonMRC Clinical Trials Unit, University College London, London, UK.ORCID 0000-0003-2651-4512
Angela CrookMRC Clinical Trials Unit, University College London, London, UK.ORCID 0000-0002-6174-8747
Paul BruinenbergTB Alliance, New York, New York, USA.
Maria BeumontTB Alliance, New York, New York, USA.
Eugene SunTB Alliance, New York, New York, USA.
Francesca ConradieIsango Lethemba TB Research Unit, CHRU, Wits Health Consortium, Gqeberha, South Africa.ORCID 0000-0002-0194-3559

Funding

Emory-Georgia TB Research Training ProgramD43TW007124 · FIC · EMORY UNIVERSITY · PI HENRY M BLUMBERG, Nestani Tukvadze · 2004 to 2026
$4.6M
FIC NIH HHS D43 TW007124
6 · The paper itself

Abstract

Pretomanid is a component of the World Health Organization-recommended treatment regimen for drug-resistant tuberculosis in patients aged ≥ 14 years. While preclinical rodent studies identified testicular toxicity as a potential clinical liability at elevated doses, no corresponding effects were observed in nonhuman primates nor clinical hormone assessments. This phase 2 clinical trial assessed testicular safety of therapy with bedaquiline, pretomanid, moxifloxacin, and pyrazinamide in 26 adult males with drug-resistant tuberculosis recruited from South Africa and Georgia. The study included 26 weeks of treatment followed by 52 weeks of safety monitoring until study week 78. The primary endpoint measured change in total sperm count from baseline at week 26, with secondary endpoints evaluating sperm concentration, semen volume, and reproductive hormone concentrations. Results demonstrated favorable testicular safety outcomes. Mean total sperm count increased from 48.8 to 68.8 × 10

Indexed as

Antitubercular AgentsNitroimidazolesSpermatogenesisTuberculosis, Multidrug-ResistantTuberculosis, PulmonaryAdultFollicle Stimulating HormoneHumansInhibinsLuteinizing HormoneMaleMiddle AgedSouth AfricaSperm CountTestisYoung AdultAntitubercular AgentsFollicle Stimulating Hormoneinhibin BInhibinsLuteinizing HormoneNitroimidazolespretomanid

Identifiers

PMID42312322
PMCPMC13339614

What OpenQuestion holds

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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.