Trial reportThe Journal of infectious diseases2025
Pharmacokinetics and Safety of Clofazimine in Children With Rifampicin-Resistant Tuberculosis.
Trial report in The Journal of infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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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.
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.
Who cites it
4 citing papers in PubMed.
- Pharmacokinetics of Clofazimine Tablet Formulation in Children with Rifampicin-Resistant Tuberculosis in CATALYST, a Multi-Site International Trial.Journal of the Pediatric Infectious Diseases Society · 2026Article
- Exposure-QTc modeling of bedaquiline, pretomanid, and clofazimine in adults with tuberculosis.Antimicrobial agents and chemotherapy · 2026Article
- Global child-friendly anti-TB medicines - where do we stand?IJTLD open · 2025Article
- Acceptability of a clofazimine tablet in children with rifampicin-resistant TB in three high-burden countries.IJTLD open · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
backgroundWe described the pharmacokinetics and safety of clofazimine in children treated for multidrug/rifampicin-resistant tuberculosis (MDR/RR-TB).
methodsChildren aged <18 years were eligible. Clofazimine was administered by weight-based dosing. Sparse and semi-intensive pharmacokinetic sampling was completed at baseline and weeks 2 and 16. Clofazimine weekly area under the concentration time-curve (wAUC) was compared with the target wAUC (60.87 mg × h/L and 111.79 mg × h/L) in adults receiving clofazimine (100 mg) daily for MDR/RR-TB and leprosy, respectively. Safety monitoring included measurement of QT interval prolongation and laboratory assessment.
resultsTwenty children were included: median age was 6.0 years (IQR, 1.6-14.4); 6 (30%) were male. Median clofazimine wAUC was 162.94 (IQR, 130.06-263.95), >25% higher than the target adult wAUC in adults with MDR/RR-TB (111.79; IQR, 81.9-151.9). No serious or grade ≥3 cardiac events occurred. There was a QT interval increase of 0.02 milliseconds for every 1-µg/L increase in clofazimine concentration. One severe adverse event (elevated alanine transferase) led to temporary withdrawal of clofazimine.
conclusionsThe clofazimine doses used achieved substantially higher exposures in children than adults receiving standard clofazimine doses. The association of higher clofazimine exposures and QT interval prolongation may pose unnecessary risk to children, particularly in combination with other QT-prolonging drugs. CLINICAL TRIALS REGISTRATION: South African National Clinical Trials Register (https://sanctr.samrc.ac.za/; DOH-27-0620-6415).
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