Author:
Ndege Robert,Ngome Omary,Bani Farida,Temba Yvan,Wilson Herieth,Vanobberghen Fiona,Hella Jerry,Gingo Winfrid,Sasamalo Mohamed,Mnzava Dorcas,Kimera Namvua,Hiza Helen,Wigayi John,Mapesi Herry,Kato Irene B.,Mhimbira Francis,Reither Klaus,Battegay Manuel,Paris Daniel H.,Weisser Maja,Rohacek Martin
Abstract
Abstract
Background
Patients with clinically suspected tuberculosis are often treated empirically, as diagnosis - especially of extrapulmonary tuberculosis - remains challenging. This leads to an overtreatment of tuberculosis and to underdiagnosis of possible differential diagnoses.
Methods
This open-label, parallel-group, superiority randomized controlled trial is done in a rural and an urban center in Tanzania. HIV-positive and -negative adults (≥18 years) with clinically suspected extrapulmonary tuberculosis are randomized in a 1:1 ratio to an intervention- or control group, stratified by center and HIV status. The intervention consists of a management algorithm including extended focused assessment of sonography for HIV and tuberculosis (eFASH) in combination with chest X-ray and microbiological tests. Treatment with anti-tuberculosis drugs is started, if eFASH is positive, chest X-ray suggests tuberculosis, or a microbiological result is positive for tuberculosis. Patients in the control group are managed according national guidelines. Treatment is started if microbiology is positive or empirically according to the treating physician. The primary outcome is the proportion of correctly managed patients at 6 months (i.e patients who were treated with anti-tuberculosis treatment and had definite or probable tuberculosis, and patients who were not treated with anti-tuberculosis treatment and did not have tuberculosis). Secondary outcomes are the proportion of symptom-free patients at two and 6 months, and time to death. The sample size is 650 patients.
Discussion
This study will determine, whether ultrasound in combination with other tests can increase the proportion of correctly managed patients with clinically suspected extrapulmonary tuberculosis, thus reducing overtreatment with anti-tuberculosis drugs.
Trial registration
PACTR, Registration number: PACTR201712002829221, registered December 1st 2017.
Funder
Rudolf Geigy Foundation Basel, Switzerland
Gottfried and Julia Bangerter-Rhyner Foundation, Basel, Switzerland
Publisher
Springer Science and Business Media LLC
Cited by
8 articles.
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