Evidence map›Paper›PMID 37832571›Full record

ArticleThe Lancet. Microbe2023

Effect of seven anti-tuberculosis treatment regimens on sputum microbiome: a retrospective analysis of the HIGHRIF study 2 and PanACEA MAMS-TB clinical trials.

Emmanuel Musisi, Adam Wyness, Sahar Eldirdiri, Evelin Dombay, Bariki Mtafya, Nyanda E Ntinginya, Norbert Heinrich, Gibson S Kibiki, Michael Hoelscher, Martin Boeree and 4 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in The Lancet. Microbe, 2023. 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 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.5field-weighted citation impact, top 17% 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.

NCT00760149 phase2completednot on this map

Pharmacokinetics and Pharmacodynamics of High Versus Standard Dose Rifampicin in Patients With Pulmonary Tuberculosis in the Kilimanjaro Region, Tanzania.

TypeinterventionalSponsorRadboud University Medical CenterRan2010 to 2013Enrolled150ConditionsTuberculosisArmsRifampicin in higher doses
NCT01785186 phase2completednot on this map

A Multiple Arm, Multiple Stage, Phase 2, OL, Randomized, Controlled Trial to Evaluate 4 Treatment Regimens of SQ109, Increased Doses of Rifampicin, and Moxifloxacin in Adults With Newly Diagnosed, Smear-positive Pulmonary Tuberculosis

TypeinterventionalSponsorMichael HoelscherRan2013 to 2015Enrolled365ConditionsTuberculosis, PulmonaryArmsSQ109, Rifampicin, Moxifloxacin, isoniazid, pyrazinamide
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 10 citations in OpenAlex.

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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 at 8 institutions in 4 countries.

Emmanuel MusisiDivision of Infection and Global Health, School of Medicine, University of St Andrews, St Andrews, UK.
Adam WynessDivision of Infection and Global Health, School of Medicine, University of St Andrews, St Andrews, UK; Scottish Association of Marine Science, Oban, UK.
Sahar EldirdiriDepartment of Microbiology, Kettering General Hospital, Kettering, UK.
Evelin DombayDivision of Infection and Global Health, School of Medicine, University of St Andrews, St Andrews, UK.
Bariki MtafyaDivision of Infection and Global Health, School of Medicine, University of St Andrews, St Andrews, UK; National Institute for Medical Research, Mbeya Medical Research Centre, Mbeya, Tanzania.
Nyanda E NtinginyaNational Institute for Medical Research, Mbeya Medical Research Centre, Mbeya, Tanzania.
Norbert HeinrichDivision of Infectious Diseases and Tropical Medicine, University Hospital, University of Munich (LMU), Munich, Germany.
Gibson S KibikiKilimanjaro Clinical Research Institute, Moshi, Tanzania; Africa Research Excellence Fund (AREF), London, UK.
Michael HoelscherDivision of Infectious Diseases and Tropical Medicine, University Hospital, University of Munich (LMU), Munich, Germany; Fraunhofer ITMP, Immunology, Infection and Pandemic Research, Munich, Germany.
Martin BoereeDepartment of Lung Diseases, Radboud University Medical Centre, Nijmegen, Netherlands.
Rob AarnoutseDepartment of Pharmacy, Radboud University Medical Centre, Nijmegen, Netherlands.
Stephen H GillespieDivision of Infection and Global Health, School of Medicine, University of St Andrews, St Andrews, UK.
Wilber SabiitiDivision of Infection and Global Health, School of Medicine, University of St Andrews, St Andrews, UK. Electronic address: ws31@st-andrews.ac.uk.
PanACEA consortium
University of St Andrews · GBNational Institute for Medical Research · TZRadboud University Nijmegen · NLFraunhofer Institute for Translational Medicine and Pharmacology · DEKilimanjaro Christian Medical Centre · TZLudwig-Maximilians-Universität München · DEKettering General Hospital · GBRadboud University Medical Center · NL

Funding

Medical Research Council MC_UU_00004/04Medical Research Council MC_UU_12023/27
6 · The paper itself

Abstract

backgroundRespiratory tract microbiota has been described as the gatekeeper for respiratory health. We aimed to assess the impact of standard-of-care and experimental anti-tuberculosis treatment regimens on the respiratory microbiome and implications for treatment outcomes.

methodsIn this retrospective study, we analysed the sputum microbiome of participants with tuberculosis treated with six experimental regimens versus standard-of-care who were part of the HIGHRIF study 2 (NCT00760149) and PanACEA MAMS-TB (NCT01785186) clinical trials across a 3-month treatment follow-up period. Samples were from participants in Mbeya, Kilimanjaro, Bagamoyo, and Dar es Salaam, Tanzania. Experimental regimens were composed of different combinations of rifampicin (R), isoniazid (H), pyrazinamide (Z), ethambutol (E), moxifloxacin (M), and a new drug, SQ109 (Q). Reverse transcription was used to create complementary DNA for each participant's total sputum RNA and the V3-V4 region of the 16S rRNA gene was sequenced using the Illumina metagenomic technique. Qiime was used to analyse the amplicon sequence variants and estimate alpha diversity. Descriptive statistics were applied to assess differences in alpha diversity pre-treatment and post-treatment initiation and the effect of each treatment regimen.

findingsSequence data were obtained from 397 pre-treatment and post-treatment samples taken between Sept 26, 2008, and June 30, 2015, across seven treatment regimens. Pre-treatment microbiome (206 genera) was dominated by Firmicutes (2860 [44%] of 6500 amplicon sequence variants [ASVs]) at the phylum level and Streptococcus (2340 [36%] ASVs) at the genus level. Two regimens had a significant depressing effect on the microbiome after 2 weeks of treatment, HR

interpretationHR

fundingEuropean and Developing Countries Clinical Trials Partnership and German Ministry of Education and Research.

Indexed as

MicrobiotaTuberculosisTuberculosis, PulmonaryAntitubercular AgentsClinical Trials as TopicDrug Therapy, CombinationHumansMoxifloxacinRetrospective StudiesRNA, Ribosomal, 16SSputumTanzaniaAntitubercular AgentsMoxifloxacinRNA, Ribosomal, 16S

Identifiers

PMID37832571
PMCPMC7617392
OpenAlexW4387637035

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.