Evidence map›Paper›PMID 25337749›Full record

Trial reportThe New England journal of medicine2014

High-dose rifapentine with moxifloxacin for pulmonary tuberculosis.

Amina Jindani, Thomas S Harrison, Andrew J Nunn, Patrick P J Phillips, Gavin J Churchyard, Salome Charalambous, Mark Hatherill, Hennie Geldenhuys, Helen M McIlleron, Simbarashe P Zvada and 14 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

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 2 registered trials, which are not on this map. Cited by 231 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
231citing papers in PubMed, 13 pooled it
29.8field-weighted citation impact, top 1% of its field
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.

NCT02821832 phase2completednot on this mapstarted 2017, after this paper: background citation

Using Biomarkers to Predict TB Treatment Duration

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2017 to 2022Enrolled946ConditionsPulmonary TuberculosisArmsSaliva collection, Urine collection, Sputum collection, Blood Collection, PET/CT Scan
NCT06253715 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

Shortened Regimen for Drug-susceptible TB in Children

TypeinterventionalSponsorJohns Hopkins UniversityRan2025 to 2027Enrolled860ConditionsTuberculosis, Tuberculosis, Pulmonary, Tuberculosis, Lymph Node, Mycobacterium TuberculosisArmsIsoniazid, Rifampin, Pyrazinamide, Ethambutol, Rifapentine
3 · Its place in the literature

Who cites it

231 citing papers in PubMed, 13 syntheses or guidelines pooled it, 442 citations in OpenAlex.

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  3. 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 · 2024
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  10. Guideline
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  14. Trial
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  17. Treatment Strategy for Rifampin-Susceptible Tuberculosis.The New England journal of medicine · 2023
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171 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors at 7 institutions in 3 countries.

Amina JindaniFrom St. George's, University of London (A.J., D.A.M., T.S.H., D.C., P.D.B.), Medical Research Council Clinical Trials Unit at University College London (A.J.N., P.P.J.P., H.E.C.), and University College London Centre for Clinical Biology, University College London (A.L.E.B., T.D.M.), London; Aurum Institute (G.J.C., S.C.) and School of Public Health, University of the Witwatersrand (G.J.C.), Johannesburg, and South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and School of Child and Adolescent Health (M.H., H.G.) and Division of Clinical Pharmacology, Department of Medicine (H.M.M., S.P.Z.), University of Cape Town, Cape Town - all in South Africa; Harare City Health Department, Harare (S.M., N.A.S.S.), and Medical Directorate of Mashonaland East, Marondera (S.Z., L.M.) - both in Zimbabwe; CDC, Gaborone, Botswana (J.S., S.N.); and Macha Research Trust, Macha, Zambia (J.H.D.).
Thomas S Harrison
Andrew J Nunn
Patrick P J Phillips
Gavin J Churchyard
Salome Charalambous
Mark Hatherill
Hennie Geldenhuys
Helen M McIlleron
Simbarashe P Zvada
Stanley Mungofa
Nasir A Shah
Simukai Zizhou
Lloyd Magweta
James Shepherd
Sambayawo Nyirenda
Janneke H van Dijk
Heather E Clouting
David Coleman
Anna L E Bateson
Timothy D McHugh
Philip D Butcher
Denny A Mitchison
RIFAQUIN Trial Team
St George's, University of London · GBUniversity College London · GBUniversity of Cape Town · ZAAurum Institute · ZAMedical Research Council · GBGolden Valley Agricultural Research Trust · ZMSouth African Tuberculosis Vaccine Initiative · ZA

Funding

Medical Research Council MC_U122888469Wellcome Trust 081199
6 · The paper itself

Abstract

backgroundTuberculosis regimens that are shorter and simpler than the current 6-month daily regimen are needed.

methodsWe randomly assigned patients with newly diagnosed, smear-positive, drug-sensitive tuberculosis to one of three regimens: a control regimen that included 2 months of ethambutol, isoniazid, rifampicin, and pyrazinamide administered daily followed by 4 months of daily isoniazid and rifampicin; a 4-month regimen in which the isoniazid in the control regimen was replaced by moxifloxacin administered daily for 2 months followed by moxifloxacin and 900 mg of rifapentine administered twice weekly for 2 months; or a 6-month regimen in which isoniazid was replaced by daily moxifloxacin for 2 months followed by one weekly dose of both moxifloxacin and 1200 mg of rifapentine for 4 months. Sputum specimens were examined on microscopy and after culture at regular intervals. The primary end point was a composite treatment failure and relapse, with noninferiority based on a margin of 6 percentage points and 90% confidence intervals.

resultsWe enrolled a total of 827 patients from South Africa, Zimbabwe, Botswana, and Zambia; 28% of patients were coinfected with the human immunodefiency virus. In the per-protocol analysis, the proportion of patients with an unfavorable response was 4.9% in the control group, 3.2% in the 6-month group (adjusted difference from control, -1.8 percentage points; 90% confidence interval [CI], -6.1 to 2.4), and 18.2% in the 4-month group (adjusted difference from control, 13.6 percentage points; 90% CI, 8.1 to 19.1). In the modified intention-to-treat analysis these proportions were 14.4% in the control group, 13.7% in the 6-month group (adjusted difference from control, 0.4 percentage points; 90% CI, -4.7 to 5.6), and 26.9% in the 4-month group (adjusted difference from control, 13.1 percentage points; 90% CI, 6.8 to 19.4).

conclusionsThe 6-month regimen that included weekly administration of high-dose rifapentine and moxifloxacin was as effective as the control regimen. The 4-month regimen was not noninferior to the control regimen. (Funded by the European and Developing Countries Clinical Trials Partnership and the Wellcome Trust; RIFAQUIN Current Controlled Trials number, ISRCTN44153044.).

Indexed as

AdolescentAdultAntitubercular AgentsCoinfectionDrug Administration ScheduleDrug Therapy, CombinationEthambutolFemaleFluoroquinolonesHIV SeropositivityHumansIsoniazidKaplan-Meier EstimateMaleMiddle AgedMoxifloxacinAntitubercular AgentsEthambutolFluoroquinolonesIsoniazidMoxifloxacinPyrazinamideRifampinrifapentine

Identifiers

PMID25337749
PMCPMC4233406
OpenAlexW2111276287

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.