Evidence map›Paper›PMID 38720383›Full record

ArticleTrials2024

Testing novel strategies for patients hospitalised with HIV-associated disseminated tuberculosis (NewStrat-TB): protocol for a randomised controlled trial.

Phiona E Namale, Linda Boloko, Marcia Vermeulen, Kate A Haigh, Fortuna Bagula, Alexis Maseko, Bianca Sossen, Scott Lee-Jones, Yoliswa Msomi, Helen McIlleron and 40 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04951986 (Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

NCT04951986 phase3active not recruitingnot on this map

Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis

TypeinterventionalSponsorUniversity of Cape TownRan2021 to 2026Enrolled732ConditionsDisseminated Tuberculosis, HIVArmsRifampin, Levofloxacin, Rifampicin, Pyrazinamide, Ethambutol and Isoniazid, Prednisone, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Observational
  3. Prevalence and Mortality due toOpen forum infectious diseases · 2026
    Article
  4. Tuberculosis and HIV coinfection: Progress and challenges towards reducing incidence and mortality.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2025
    Review
  5. Tuberculosis: An Update for the Clinician.Respirology (Carlton, Vic.) · 2025
    Review
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

50 authors.

Phiona E NamaleWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa. phenidnamale@gmail.com.ORCID http://orcid.org/0000-0003-4024-0626
Linda BolokoWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Marcia VermeulenWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Kate A HaighWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Fortuna BagulaWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Alexis MasekoWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Bianca SossenDepartment of Medicine, University of Cape Town, Cape Town, South Africa.
Scott Lee-JonesWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Yoliswa MsomiWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Helen McIlleronWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Ayanda Trevor MnguniDepartment of Medicine, Khayelitsha Hospital, Cape Town, South Africa.
Thomas CredeDepartment of Medicine, University of Cape Town, Cape Town, South Africa.
Patryk SzymanskiDepartment of Medicine, University of Cape Town, Cape Town, South Africa.
Jonathan NaudeDepartment of Medicine, University of Cape Town, Cape Town, South Africa.
Sakeena EbrahimDepartment of Medicine, University of Cape Town, Cape Town, South Africa.
Yakoob VallieDepartment of Medicine, New Somerset Hospital, Cape Town, South Africa.
Muhammed Shiraz MoosaDepartment of Medicine, New Somerset Hospital, Cape Town, South Africa.
Ismail BandekerDepartment of Medicine, New Somerset Hospital, Cape Town, South Africa.
Shakeel HoosainDepartment of Medicine, New Somerset Hospital, Cape Town, South Africa.
Mark P NicolDivision of Medical Microbiology, Department of Pathology, University of Cape Town, Cape Town, South Africa.
Nazlee SamodienDivision of Medical Microbiology, Department of Pathology, University of Cape Town, Cape Town, South Africa.
Chad CentnerDivision of Medical Microbiology, Department of Pathology, University of Cape Town, Cape Town, South Africa.
Wentzel DowlingDivision of Medical Microbiology, Department of Pathology, University of Cape Town, Cape Town, South Africa.
Paolo DentiDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Freedom GumedzeDepartment of Statistical Sciences, University of Cape Town, Cape Town, South Africa.
Francesca LittleDepartment of Statistical Sciences, University of Cape Town, Cape Town, South Africa.
Arifa ParkerDepartment of Medicine, Stellenbosch University, Stellenbosch, South Africa.
Brendon PriceDivision of Anatomical Pathology, Department of Pathology, University of Cape Town, Cape Town, South Africa.
Denzil SchietekatDepartment of Medicine, Khayelitsha Hospital, Cape Town, South Africa.
Bryony SimmonsLSE Health, London School of Economics and Political Science, London, UK.
Andrew HillLSE Health, London School of Economics and Political Science, London, UK.
Robert J WilkinsonWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Ida OliphantWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Siphokazi HlunguluWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Ivy ApolisiWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Monica ToleniWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Zimkhitha AsareWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Mkanyiseli Kenneth MpalaliWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Erica BoshoffWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Denise PrinslooWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Francisco LakayWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Abulele BekiswaWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Amanda JacksonWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Ashleigh BarnesWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Ryan JohnsonWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Sean WassermanWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Gary MaartensWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
David BarrWellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Charlotte Schutz *Wellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Graeme Meintjes *Wellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.

Funding

Wellcome TrustWellcome Trust - 214321/Z/18/Z Recipient Prof Graeme Meintjes
6 · The paper itself

Abstract

backgroundHIV-associated tuberculosis (TB) contributes disproportionately to global tuberculosis mortality. Patients hospitalised at the time of the diagnosis of HIV-associated disseminated TB are typically severely ill and have a high mortality risk despite initiation of tuberculosis treatment. The objective of the study is to assess the safety and efficacy of both intensified TB treatment (high dose rifampicin plus levofloxacin) and immunomodulation with corticosteroids as interventions to reduce early mortality in hospitalised patients with HIV-associated disseminated TB.

methodsThis is a phase III randomised controlled superiority trial, evaluating two interventions in a 2 × 2 factorial design: (1) high dose rifampicin (35 mg/kg/day) plus levofloxacin added to standard TB treatment for the first 14 days versus standard tuberculosis treatment and (2) adjunctive corticosteroids (prednisone 1.5 mg/kg/day) versus identical placebo for the first 14 days of TB treatment. The study population is HIV-positive patients diagnosed with disseminated TB (defined as being positive by at least one of the following assays: urine Alere LAM, urine Xpert MTB/RIF Ultra or blood Xpert MTB/RIF Ultra) during a hospital admission. The primary endpoint is all-cause mortality at 12 weeks comparing, first, patients receiving intensified TB treatment to standard of care and, second, patients receiving corticosteroids to those receiving placebo. Analysis of the primary endpoint will be by intention to treat. Secondary endpoints include all-cause mortality at 2 and 24 weeks. Safety and tolerability endpoints include hepatoxicity evaluations and corticosteroid-related adverse events. DISCUSSION: Disseminated TB is characterised by a high mycobacterial load and patients are often critically ill at presentation, with features of sepsis, which carries a high mortality risk. Interventions that reduce this high mycobacterial load or modulate associated immune activation could potentially reduce mortality. If found to be safe and effective, the interventions being evaluated in this trial could be easily implemented in clinical practice.

trial registrationClinicalTrials.gov NCT04951986. Registered on 7 July 2021 https://clinicaltrials.gov/study/NCT04951986.

Indexed as

HIV InfectionsHospitalizationLevofloxacinRifampinTuberculosisAIDS-Related Opportunistic InfectionsAntitubercular AgentsClinical Trials, Phase III as TopicDrug Therapy, CombinationEquivalence Trials as TopicHumansPrednisoneTime FactorsTreatment OutcomeAntitubercular AgentsLevofloxacinPrednisoneRifampinDisseminated tuberculosisHigh dose rifampicinHIVLevofloxacinPrednisoneRandomised controlled trial

Identifiers

PMID38720383
PMCPMC11077808

What Socratic holds

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LicenceCC BY
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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 Socratic graph.