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Ultrasound in managing extrapulmonary tuberculosis: a randomized controlled two-center study.
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.
Affiliation
  • Ndege R; Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania. rndege@ihi.or.tz.
  • Ngome O; St Francis Referral Hospital, Ifakara, United Republic of Tanzania. rndege@ihi.or.tz.
  • Bani F; Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.
  • Temba Y; Mwananyamala Regional Referral Hospital, Dar es salaam, United Republic of Tanzania.
  • Wilson H; Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.
  • Vanobberghen F; St Francis Referral Hospital, Ifakara, United Republic of Tanzania.
  • Hella J; Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.
  • Gingo W; Mwananyamala Regional Referral Hospital, Dar es salaam, United Republic of Tanzania.
  • Sasamalo M; Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.
  • Mnzava D; St Francis Referral Hospital, Ifakara, United Republic of Tanzania.
  • Kimera N; Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland.
  • Hiza H; Faculty of Medicine, University of Basel, Basel, Switzerland.
  • Wigayi J; Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.
  • Mapesi H; St Francis Referral Hospital, Ifakara, United Republic of Tanzania.
  • Kato IB; Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.
  • Mhimbira F; Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.
  • Reither K; Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.
  • Battegay M; Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.
  • Paris DH; Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.
  • Weisser M; Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.
  • Rohacek M; Mwananyamala Regional Referral Hospital, Dar es salaam, United Republic of Tanzania.
BMC Infect Dis ; 20(1): 349, 2020 May 15.
Article in En | MEDLINE | ID: mdl-32414338
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.
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Full text: 1 Collection: 01-internacional Health context: 1_ASSA2030 / 2_ODS3 / 3_ND / 4_TD Database: MEDLINE Main subject: Tuberculosis / Ultrasonography Limits: Adult / Female / Humans / Male / Middle aged Country/Region as subject: Africa Language: En Journal: BMC Infect Dis Year: 2020 Document type: Article

Full text: 1 Collection: 01-internacional Health context: 1_ASSA2030 / 2_ODS3 / 3_ND / 4_TD Database: MEDLINE Main subject: Tuberculosis / Ultrasonography Limits: Adult / Female / Humans / Male / Middle aged Country/Region as subject: Africa Language: En Journal: BMC Infect Dis Year: 2020 Document type: Article