Evidence map›Paper›PMID 39148008›Full record

Trial reportBMC infectious diseases2024

Expanding Xpert MTB/RIF Ultra® and LF-LAM testing for diagnosis of tuberculosis among HIV-positive adults admitted to hospitals in Tanzania and Mozambique: a randomized controlled trial (the EXULTANT trial).

Chacha Mangu, Marta Cossa, Robert Ndege, Celso Khosa, Vinzeigh Leukes, Laura de la Torre-Pérez, Antonio Machiana, Bernard Kivuma, Dorcas Mnzava, Craysophy Zachariah and 20 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyPragmatic Clinical Trial
In one paragraph

Trial report in BMC infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04568967 (Expanding Xpert Ultra Testing for TB Diagnosis Among HIV-positive Patients Admitted to Hospital in Africa), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT04568967 nacompletednot on this map

Expanding Xpert Ultra Testing for TB Diagnosis Among HIV-positive Patients Admitted to Hospital in Africa

TypeinterventionalSponsorFoundation for Innovative New Diagnostics, SwitzerlandRan2022 to 2024Enrolled1,172ConditionsTuberculosis, HIV Coinfection, Diagnoses DiseaseArmsConcentrated urine with Xpert Ultra, Stool with Xpert Ultra
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Review
  3. 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

30 authors.

Chacha ManguMbeya Medical Research Centre, National Institute for Medical Research (NIMR), Mbeya, Tanzania.
Marta Cossa *Centro de Investigação Em Saúde de Manhiça (CISM), Manhica, Mozambique.
Robert NdegeIfakara Health Institute, Dar Es Salaam, Tanzania.
Celso KhosaInstituto Nacional de Saúde (INS), Marracuene, Mozambique.
Vinzeigh LeukesFIND, Geneva, Switzerland.
Laura de la Torre-PérezISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.
Antonio MachianaInstituto Nacional de Saúde (INS), Marracuene, Mozambique.
Bernard KivumaIfakara Health Institute, Dar Es Salaam, Tanzania.
Dorcas MnzavaIfakara Health Institute, Dar Es Salaam, Tanzania.
Craysophy ZachariahMbeya Medical Research Centre, National Institute for Medical Research (NIMR), Mbeya, Tanzania.
Patricia ManjateCentro de Investigação Em Saúde de Manhiça (CISM), Manhica, Mozambique.
Elisa TaglianiEmerging Bacterial Pathogens Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Claudia SchachtLINQ Management, Berlin, Germany.
Julia BuechLINQ Management, Berlin, Germany.
Sunita SinghFIND, Geneva, Switzerland.
Joanna EhrlichISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.
Friedrich RiessDivision of Infectious Diseases and Tropical Medicine, LMU University Hospital, LMU Munich, Munich, Germany.
Sergi SanzISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.
Katharina KranzerDivision of Infectious Diseases and Tropical Medicine, LMU University Hospital, LMU Munich, Munich, Germany.
Helen CoxDivision of Medical Microbiology, Department of Pathology, Institute of Infectious Disease and Molecular Medicine, and Wellcome Centre for Infectious Disease Research in Africa, University of Cape Town, Cape Town, South Africa.
Issa SabiMbeya Medical Research Centre, National Institute for Medical Research (NIMR), Mbeya, Tanzania.
Dinis NguenhaCentro de Investigação Em Saúde de Manhiça (CISM), Manhica, Mozambique.
Bindiya MeggiInstituto Nacional de Saúde (INS), Marracuene, Mozambique.
Maja WeisserIfakara Health Institute, Dar Es Salaam, Tanzania.
Nyanda NtinginyaMbeya Medical Research Centre, National Institute for Medical Research (NIMR), Mbeya, Tanzania.
Samuel SchumacherFIND, Geneva, Switzerland.
Morten RuhwaldFIND, Geneva, Switzerland.
Adam Penn-NicholsonFIND, Geneva, Switzerland.
Alberto L Garcia-BasteiroCentro de Investigação Em Saúde de Manhiça (CISM), Manhica, Mozambique. alberto.garcia-basteiro@isglobal.org.
TB-CAPT Consortium

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTuberculosis (TB) is an important cause of morbidity and mortality among people living with HIV (PLHIV). Current WHO-recommended strategies for diagnosing TB among hospitalized PLHIV rely on symptom screening and disease severity to assess eligibility for urine lipoarabinomannan lateral flow (LF-LAM) and molecular testing. Despite these recommendations, autopsy studies show a large burden of undiagnosed TB among admitted PLHIV. The EXULTANT trial aims to assess the impact of an expanded screening strategy using three specimens (sputum, stool, and urine) for TB diagnosis among PLHIV admitted to hospitals in two high HIV and TB burden African countries.

methodsThis is a multicenter, pragmatic, individually randomized controlled trial conducted across eleven hospitals in Tanzania and Mozambique. Participants in the intervention arm will be tested with Xpert MTB/RIF Ultra® from expectorated sputum, stool, and urine samples, with additional urine LF-LAM testing in the first 24 h after hospital admission, irrespective of the presence of the symptoms. The control arm will implement the WHO standard of care recommendations. Hospitalized adults (≥ 18 years) with a confirmed HIV-diagnosis, irrespective of antiretroviral (ART) therapy status or presence of TB symptoms will be assessed for eligibility at admission. Patients with a pre-existing TB diagnosis, those receiving anti-tuberculosis therapy or tuberculosis preventive treatment in the 6 months prior to enrolment, and those transferred from other hospitals will not be eligible. Also, participants admitted for traumatic reasons such as acute abdomen, maternal conditions, scheduled surgery, having a positive SARS-CoV2 test will be ineligible. The primary endpoint is the proportion of participants with microbiologically confirmed TB starting treatment within 3 days of enrolment. DISCUSSION: The EXULTANT trial investigates rapid implementation after admission of a new diagnostic algorithm using Xpert MTB/RIF Ultra® in several non-invasive specimens, in addition to LF-LAM, in hospitalized PLHIV regardless of TB symptoms. This enhanced strategy is anticipated to detect frequently missed TB cases in this population and is being evaluated as an implementable and scalable intervention.

trial registrationTrial reference number: NCT04568967 (ClinicalTrials.gov) registered on 2020-09-29.

Indexed as

HIV InfectionsTuberculosisAdultFecesFemaleHospitalizationHumansLipopolysaccharidesMaleMozambiqueMycobacterium tuberculosisSputumTanzanialipoarabinomannanLipopolysaccharidesEnhanced screeningHIVTB case-findingTB diagnosisTuberculosis

Identifiers

PMID39148008
PMCPMC11325809

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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.