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

Ndege, Robert and Ngome, Omary and Bani, Farida and Temba, Yvan and Wilson, Herieth and Vanobberghen, Fiona and Hella, Jerry and Gingo, Winfrid and Sasamalo, Mohamed and Mnzava, Dorcas and Kimera, Namvua and Hiza, Helen and Wigayi, John and Mapesi, Herry and Kato, Irene B. and Mhimbira, Francis and Reither, Klaus and Battegay, Manuel and Paris, Daniel H. and Weisser, Maja and Rohacek, Martin. (2020) Ultrasound in managing extrapulmonary tuberculosis: a randomized controlled two-center study. BMC infectious diseases, 20. p. 349.

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Abstract

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.; 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.; 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.; PACTR, Registration number: PACTR201712002829221, registered December 1st 2017.
Faculties and Departments:09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Medicine (MED)
UniBasel Contributors:Vanobberghen, Fiona and Paris, Daniel Henry and Reither, Klaus and Rohacek, Martin
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:BioMed Central
ISSN:1471-2334
Note:Publication type according to Uni Basel Research Database: Journal article
Language:English
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Last Modified:17 Jun 2020 10:10
Deposited On:17 Jun 2020 10:10

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