Trial reportThe international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease2018
Quality assurance of rifampicin-containing fixed-drug combinations in South Africa: dosing implications.
Trial report in The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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.
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
16 citing papers in PubMed, 25 citations in OpenAlex.
- Population Pharmacokinetics of Rifampicin in Plasma and Cerebrospinal Fluid in Adults With Tuberculosis Meningitis.The Journal of infectious diseases · 2025Trial
- Pharmacokinetics of ethambutol and weight banded dosing in South African adults newly diagnosed with tuberculosis and HIV.Antimicrobial agents and chemotherapy · 2025Trial
- Plasma Pharmacokinetics of High-Dose Oral versus Intravenous Rifampicin in Patients with Tuberculous Meningitis: a Randomized Controlled Trial.Antimicrobial agents and chemotherapy · 2021Trial
- Pretomanid Pharmacokinetics in the Presence of Rifamycins: Interim Results from a Randomized Trial among Patients with Tuberculosis.Antimicrobial agents and chemotherapy · 2021Trial
- Fixed Dose Combinations as an Advantage for the Treatment of Pediatric Tuberculosis: A Narrative Review.Pharmaceuticals (Basel, Switzerland) · 2026Review
- The impact of alcohol and illicit substance use on the pharmacokinetics of first-line TB drugs.The Journal of antimicrobial chemotherapy · 2024Article
- Article
- Real-world impact of the fixed-dose combination on improving treatment outcomes of drug-susceptible tuberculosis: a comparative study using multiyear national tuberculosis patient data.BMJ open respiratory research · 2023Article
- Estimating the prevalence of poor-quality anti-TB medicines: a neglected risk for global TB control and resistance.BMJ global health · 2023Article
- Pharmacokinetics and safety of high-dose rifampicin in children with TB: the Opti-Rif trial.The Journal of antimicrobial chemotherapy · 2021Article
- Advancing the development of new tuberculosis treatment regimens: The essential role of translational and clinical pharmacology and microbiology.PLoS medicine · 2019Review
- Low Antituberculosis Drug Concentrations in HIV-Tuberculosis-Coinfected Adults with Low Body Weight: Is It Time To Update Dosing Guidelines?Antimicrobial agents and chemotherapy · 2019Article
- Association of anti-tuberculosis drug concentrations in hair and treatment outcomes in MDR- and XDR-TB.ERJ open research · 2019Article
- Current research toward optimizing dosing of first-line antituberculosis treatment.Expert review of anti-infective therapy · 2019Review
- Effect of Diabetes Mellitus on the Pharmacokinetics and Pharmacodynamics of Tuberculosis Treatment.Antimicrobial agents and chemotherapy · 2018Article
- Making up the difference: ensuring the bioequivalence of fixed-dose combinations for tuberculosis.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2018Article
Corrections and comments
- Commented on by
Authors and funding
7 authors at 1 institution in 1 country.
Funding
Abstract
settingRifampicin (RMP) drives treatment response in drug-susceptible tuberculosis. Low RMP concentrations increase the risk of poor outcomes, and drug quality needs to be excluded as a contributor to low RMP exposure. OBJECTIVES AND
designWe performed an open-label, three-way cross-over study of three licensed RMP-containing formulations widely used in South Africa to evaluate the bioavailability of RMP in a two-drug fixed-dose combination tablet (2FDC) and a four-drug FDC (4FDC) against a single-drug reference. RMP dosed at 600 mg was administered 2 weeks apart in random sequence. Plasma RMP concentrations were measured pre-dose and 1, 2, 3, 4, 6, 8 and 12 h post-dose. The area under the concentration-time curve (AUC0-12) of the FDCs was compared to the single drug reference. Simulations were used to predict the impact of our findings.
resultsTwenty healthy volunteers (median age 22.8 years, body mass index 24.2 kg/m2) completed the study. The AUC0-12 of the 4FDC/reference (geometric mean ratio [GMR] 78%, 90%CI 69-89) indicated an average 20% reduction in RMP bioavailability in the 4FDC. The 2FDC/reference (GMR 104%, 90%CI 97-111) was bioequivalent. Simulations suggested dose adjustments to compensate for the poor bioavailability of RMP with the 4FDC, and revised weight-band doses to prevent systematic underdosing of low-weight patients.
conclusionPost-marketing surveillance of in vivo bioavailability of RMP and improved weight band-based dosing are recommended.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.