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).
Enhanced screening
HIV
TB case-finding
TB diagnosis
Tuberculosis
Journal
BMC infectious diseases
ISSN: 1471-2334
Titre abrégé: BMC Infect Dis
Pays: England
ID NLM: 100968551
Informations de publication
Date de publication:
15 Aug 2024
15 Aug 2024
Historique:
received:
20
02
2024
accepted:
23
07
2024
medline:
16
8
2024
pubmed:
16
8
2024
entrez:
15
8
2024
Statut:
epublish
Résumé
Tuberculosis (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. This 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. 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 reference number: NCT04568967 (ClinicalTrials.gov) registered on 2020-09-29.
Identifiants
pubmed: 39148008
doi: 10.1186/s12879-024-09651-z
pii: 10.1186/s12879-024-09651-z
doi:
Substances chimiques
lipoarabinomannan
0
Lipopolysaccharides
0
Banques de données
ClinicalTrials.gov
['NCT04568967']
Types de publication
Journal Article
Randomized Controlled Trial
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
831Investigateurs
Berra Erkosar
(B)
Muhuminu Nuru
(M)
Mahmud Mahmud
(M)
Neema Shija
(N)
Deogratias Bulime
(D)
Petro Sabuni
(P)
Hosiana Temba
(H)
Jamali Siru
(J)
Jerry Hella
(J)
Jonathan Msafiri
(J)
Mohamed Mbaruku
(M)
Mohamed Sasamalo
(M)
Alice Leonard
(A)
Ambilikile Malango
(A)
Annastazia Alexander
(A)
Faith Komakoma
(F)
Gloria Msigala
(G)
Kasmir Johaness
(K)
Grace Mhalu
(G)
Mwajabu Hamis
(M)
Priscilla Mlay
(P)
Sera Barasa
(S)
Swalehe Masoud
(S)
Theonestina Byakuzana
(T)
Anange Lwilla
(A)
Pauline Sylvester
(P)
Emanuel Sichone
(E)
Subira Wailes
(S)
Bariki Mtafya
(B)
Abisai Kisinda
(A)
Malendeja Martine
(M)
Regino Mgaya
(R)
Christina Manyama
(C)
Theodora Mbunda
(T)
Elimina Siyame
(E)
Last Mwaipopo
(L)
Nyanda Elias Ntinginya
(NE)
Raphael Edom
(R)
Willyhelmina Olomi
(W)
Delio Elisio
(D)
None Edson Mambuque
Joaquim Cossa
(J)
Neide Gomes
(N)
Shilzia Munguambe
(S)
Sozinho Acacio
(S)
Helio Chiconela
(H)
Katia Ribeiro
(K)
Carla Madeira
(C)
Daniel Machavae
(D)
Emelva Manhiça
(E)
Onelia Guiliche
(O)
Diosdélio Malamule
(D)
Sofia Viegas
(S)
Belén Saavedra
(B)
Carlos Fernández-Escobar
(C)
Michael Hoelscher
(M)
Norbert Heinrich
(N)
Leyla Larsson
(L)
Maria Del Mar Castro Noriega
(M)
Claudia Denkinger
(C)
Saima Arif
(S)
Daniela Maria Cirillo
(DM)
Federico Di Marco
(F)
Virginia Batignani
(V)
Akash Malhotra
(A)
David Dowdy
(D)
Caroline Stöhr
(C)
Marguerite Massinga Loembé
(MM)
Pascale Ondoa
(P)
Nqobile Ndlovu
(N)
Fumbani Brown
(F)
Yonas Ghebrekristos
(Y)
Cindy Hayes
(C)
Ilse Vanderwalt
(I)
Shareef Abrahams
(S)
Puleng Marokane
(P)
Mbuti Radebe
(M)
Neil Martinson
(N)
Anura David
(A)
Lesley Scott
(L)
Lucky Ngwenya
(L)
Pedro Da Silva
(P)
Riffat Munir
(R)
Wendy Stevens
(W)
Charles Abongomera
(C)
Klaus Reither
(K)
Leon Stieger
(L)
Adrian Brink
(A)
Chad Centner
(C)
Judi van Heerden
(J)
Mark Nicol
(M)
Nchimunya Hapeela
(N)
Parveen Brown
(P)
Reyhana Solomon
(R)
Widaad Zemanay
(W)
Tania Dolby
(T)
Informations de copyright
© 2024. The Author(s).
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