Trial reportThe New England journal of medicine2014
Four-month moxifloxacin-based regimens for drug-sensitive tuberculosis.
Trial report in The New England journal of medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 356 papers, 8 of them syntheses that pooled 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.
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.
A Randomised Placebo - Controlled Double Blind Trial Comparing 1) a Two Month Intensive Phase of Ethambutol, Moxifloxacin, Rifampicin, Pyrazinamide Versus the Standard Regimen (Ethambutol, Isoniazid, Rifampicin, Pyrazinamide) and 2) a Treatment Shortening Regimen Comparing Two Months Moxifloxacin, Isoniazid, Rifampicin, Pyrazinamide Followed by Two Months Moxifloxacin, Isoniazid, Rifampicin Versus the Standard Regimen (Two Months Ethambutol, Isoniazid, Rifampicin, Pyrazinamide Followed by Four Months Isoniazid and Rifampicin) for the Treatment of Adults With Pulmonary Tuberculosis
Using Biomarkers to Predict TB Treatment Duration
A Prospective, Randomized Controlled Study for the Efficacy and Safety of the Substitution of Pyrazinamide and Ethambutol With Moxifloxacin During the Intensive Phase of Treatment of Pulmonary Tuberculosis
Shortened Regimen for Drug-susceptible TB in Children
Candidate Clinical Correlate of Prognostic Outcome for TB Study
Who cites it
356 citing papers in PubMed, 8 syntheses or guidelines pooled it, 643 citations in OpenAlex.
- Treatment shortening and relapse control in drug-susceptible pulmonary tuberculosis: a network meta-analysis of randomized trials.Frontiers in cellular and infection microbiology · 2026Pooled it
- Comparative efficacy and safety of high-dose rifamycin regimens for tuberculosis treatment: a Bayesian network meta-analysis.BMJ open · 2025Pooled it
- Subclinical tuberculosis: a meta-analysis of prevalence and scoping review of definitions, prevalence and clinical characteristics.European respiratory review : an official journal of the European Respiratory Society · 2024Pooled it
- Pooled it
- A systematic review of endpoint definitions in late phase pulmonary tuberculosis therapeutic trials.Trials · 2021Pooled it
- Pooled it
- Shortened treatment regimens versus the standard regimen for drug-sensitive pulmonary tuberculosis.The Cochrane database of systematic reviews · 2019Pooled it
- Diabetes mellitus comorbidity in patients enrolled in tuberculosis drug efficacy trials around the world: A systematic review.British journal of clinical pharmacology · 2019Pooled it
- Efficacy and safety of a 4-month quabodepistat, delamanid, and bedaquiline regimen for drug-susceptible pulmonary tuberculosis: a multicentre, open-label, randomised, proof-of-concept, non-inferiority, phase 2b/c trial.The Lancet. Infectious diseases · 2026Trial
- Applying a Pharmacometrics-Enabled Machine Learning Analysis to Predict 2-Month Culture Conversion Using Phase 2a Data in a Tuberculosis Clinical Trial.Clinical and translational science · 2026Trial
- Pharmacokinetics, bactericidal activity and toxicity of short oral regimens for rifampicin-resistant tuberculosis treatment.Nature communications · 2026Trial
- Clinical testing of drug treatment shortening in patients with TB using PET/CT imaging of lung lesions.Science translational medicine · 2026Trial
- Risk-stratified treatment for drug-susceptible pulmonary tuberculosis.Nature communications · 2024Trial
- Safety and Efficacy of 25 mg/kg and 35 mg/kg vs 10 mg/kg Rifampicin in Pulmonary TB: A Phase IIb Randomized Controlled Trial.Open forum infectious diseases · 2024Trial
- A flexible multi-metric Bayesian framework for decision-making in Phase II multi-arm multi-stage studies.Statistics in medicine · 2024Trial
- Radiographic characteristics of rifampicin-resistant tuberculosis in the STREAM stage 1 trial and their influence on time to culture conversion in the short regimen.BMC infectious diseases · 2024Trial
- A Standardized Approach for Collection of Objective Data to Support Outcome Determination for Late-Phase Tuberculosis Clinical Trials.American journal of respiratory and critical care medicine · 2023Trial
- Treatment Strategy for Rifampin-Susceptible Tuberculosis.The New England journal of medicine · 2023Trial
- Efavirenz Pharmacokinetics and Human Immunodeficiency Virus Type 1 (HIV-1) Viral Suppression Among Patients Receiving Tuberculosis Treatment Containing Daily High-Dose Rifapentine.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Trial
- Comparing timelines and evidence available to support new TB, HIV, and HCV drug approvals: The same, only different.PloS one · 2022Trial
296 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
10 authors at 4 institutions in 3 countries.
Funding
Abstract
backgroundEarly-phase and preclinical studies suggest that moxifloxacin-containing regimens could allow for effective 4-month treatment of uncomplicated, smear-positive pulmonary tuberculosis.
methodsWe conducted a randomized, double-blind, placebo-controlled, phase 3 trial to test the noninferiority of two moxifloxacin-containing regimens as compared with a control regimen. One group of patients received isoniazid, rifampin, pyrazinamide, and ethambutol for 8 weeks, followed by 18 weeks of isoniazid and rifampin (control group). In the second group, we replaced ethambutol with moxifloxacin for 17 weeks, followed by 9 weeks of placebo (isoniazid group), and in the third group, we replaced isoniazid with moxifloxacin for 17 weeks, followed by 9 weeks of placebo (ethambutol group). The primary end point was treatment failure or relapse within 18 months after randomization.
resultsOf the 1931 patients who underwent randomization, in the per-protocol analysis, a favorable outcome was reported in fewer patients in the isoniazid group (85%) and the ethambutol group (80%) than in the control group (92%), for a difference favoring the control group of 6.1 percentage points (97.5% confidence interval [CI], 1.7 to 10.5) versus the isoniazid group and 11.4 percentage points (97.5% CI, 6.7 to 16.1) versus the ethambutol group. Results were consistent in the modified intention-to-treat analysis and all sensitivity analyses. The hazard ratios for the time to culture negativity in both solid and liquid mediums for the isoniazid and ethambutol groups, as compared with the control group, ranged from 1.17 to 1.25, indicating a shorter duration, with the lower bounds of the 95% confidence intervals exceeding 1.00 in all cases. There was no significant difference in the incidence of grade 3 or 4 adverse events, with events reported in 127 patients (19%) in the isoniazid group, 111 (17%) in the ethambutol group, and 123 (19%) in the control group.
conclusionsThe two moxifloxacin-containing regimens produced a more rapid initial decline in bacterial load, as compared with the control group. However, noninferiority for these regimens was not shown, which indicates that shortening treatment to 4 months was not effective in this setting. (Funded by the Global Alliance for TB Drug Development and others; REMoxTB ClinicalTrials.gov number, NCT00864383.).
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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.