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Randomized Controlled Trial
. 2020 May 15;20(1):349.
doi: 10.1186/s12879-020-05073-9.

Ultrasound in managing extrapulmonary tuberculosis: a randomized controlled two-center study

Robert Ndege  1   2 , Omary Ngome  3   4 , Farida Bani  3   5 , Yvan Temba  3   4 , Herieth Wilson  3   5 , Fiona Vanobberghen  6   7 , Jerry Hella  3 , Winfrid Gingo  5 , Mohamed Sasamalo  3 , Dorcas Mnzava  3 , Namvua Kimera  3 , Helen Hiza  3 , John Wigayi  3 , Herry Mapesi  3 , Irene B Kato  4 , Francis Mhimbira  3 , Klaus Reither  6   7 , Manuel Battegay  7   8 , Daniel H Paris  6   7 , Maja Weisser  3   7   8 , Martin Rohacek  9   10   11   12
Affiliations
Randomized Controlled Trial

Ultrasound in managing extrapulmonary tuberculosis: a randomized controlled two-center study

Robert Ndege et al. BMC Infect Dis. .

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.

Keywords: Extrapulmonary; FASH; Sonography; Sub-Saharan Africa; Tuberculosis.

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Conflict of interest statement

The authors report that there are no conflicts of interest.

Figures

Fig. 1
Fig. 1
Algorithm for management of intervention group and control group. LN: lymph node; TB: Tuberculosis; eFASH: Extended Focused Assessment with Sonography for HIV and Tuberculosis; PE: pericardial effusion. † anti-tuberculosis treatment is started in case of a positive microbiological result
See this image and copyright information in PMC

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