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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).
Mangu, Chacha; Cossa, Marta; Ndege, Robert; Khosa, Celso; Leukes, Vinzeigh; de la Torre-Pérez, Laura; Machiana, Antonio; Kivuma, Bernard; Mnzava, Dorcas; Zachariah, Craysophy; Manjate, Patricia; Tagliani, Elisa; Schacht, Claudia; Buech, Julia; Singh, Sunita; Ehrlich, Joanna; Riess, Friedrich; Sanz, Sergi; Kranzer, Katharina; Cox, Helen; Sabi, Issa; Nguenha, Dinis; Meggi, Bindiya; Weisser, Maja; Ntinginya, Nyanda; Schumacher, Samuel; Ruhwald, Morten; Penn-Nicholson, Adam; Garcia-Basteiro, Alberto L.
Affiliation
  • Mangu C; Mbeya Medical Research Centre, National Institute for Medical Research (NIMR), Mbeya, Tanzania.
  • Cossa M; Centro de Investigação Em Saúde de Manhiça (CISM), Manhica, Mozambique.
  • Ndege R; Ifakara Health Institute, Dar Es Salaam, Tanzania.
  • Khosa C; Swiss Tropical and Public Health Institute, Allschwill, Switzerland.
  • Leukes V; Instituto Nacional de Saúde (INS), Marracuene, Mozambique.
  • de la Torre-Pérez L; FIND, Geneva, Switzerland.
  • Machiana A; ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.
  • Kivuma B; Instituto Nacional de Saúde (INS), Marracuene, Mozambique.
  • Mnzava D; Ifakara Health Institute, Dar Es Salaam, Tanzania.
  • Zachariah C; Ifakara Health Institute, Dar Es Salaam, Tanzania.
  • Manjate P; Mbeya Medical Research Centre, National Institute for Medical Research (NIMR), Mbeya, Tanzania.
  • Tagliani E; Centro de Investigação Em Saúde de Manhiça (CISM), Manhica, Mozambique.
  • Schacht C; Emerging Bacterial Pathogens Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Buech J; LINQ Management, Berlin, Germany.
  • Singh S; LINQ Management, Berlin, Germany.
  • Ehrlich J; FIND, Geneva, Switzerland.
  • Riess F; ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.
  • Sanz S; Division of Infectious Diseases and Tropical Medicine, LMU University Hospital, LMU Munich, Munich, Germany.
  • Kranzer K; ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.
  • Cox H; Division of Infectious Diseases and Tropical Medicine, LMU University Hospital, LMU Munich, Munich, Germany.
  • Sabi I; Institute of Infectious Diseases and Tropical Medicine, LMU University Hospital, LMU Munich German Center for Infection Research (DZIF), Munich, Germany.
  • Nguenha D; Division 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.
  • Meggi B; Mbeya Medical Research Centre, National Institute for Medical Research (NIMR), Mbeya, Tanzania.
  • Weisser M; Centro de Investigação Em Saúde de Manhiça (CISM), Manhica, Mozambique.
  • Ntinginya N; Instituto Nacional de Saúde (INS), Marracuene, Mozambique.
  • Schumacher S; Ifakara Health Institute, Dar Es Salaam, Tanzania.
  • Ruhwald M; Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland.
  • Penn-Nicholson A; Mbeya Medical Research Centre, National Institute for Medical Research (NIMR), Mbeya, Tanzania.
  • Garcia-Basteiro AL; FIND, Geneva, Switzerland.
BMC Infect Dis ; 24(1): 831, 2024 Aug 15.
Article in En | MEDLINE | ID: mdl-39148008
ABSTRACT

INTRODUCTION:

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.

METHODS:

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.

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 REGISTRATION Trial reference number NCT04568967 (ClinicalTrials.gov) registered on 2020-09-29.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Tuberculosis / HIV Infections Limits: Adult / Female / Humans / Male Country/Region as subject: Africa Language: En Journal: BMC Infect Dis Year: 2024 Document type: Article

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Tuberculosis / HIV Infections Limits: Adult / Female / Humans / Male Country/Region as subject: Africa Language: En Journal: BMC Infect Dis Year: 2024 Document type: Article