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Ultrasononography in Managing Extrapulmonary Tuberculosis: A Randomized, Controlled, Parallel, Superiority, Open-Label Trial.
Ndege, Robert; Ngome, Omary; Vanobberghen, Fiona; Bani, Farida; Temba, Yvan; Wilson, Herieth; Hella, Jerry; Gingo, Winfrid; Sasamalo, Mohamed; Mnzava, Dorcas; Kimera, Namvua; Hiza, Hellen; 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.
  • Ngome O; Saint Francis Referral Hospital, Ifakara, United Republic of Tanzania.
  • Vanobberghen F; Swiss Tropical and Public Public Health Institute, Allschwil, Switzerland.
  • Bani F; University of Basel, Basel, Switzerland.
  • Temba Y; Ifakara Health Institute, Ifakara, United Republic of Tanzania.
  • Wilson H; Mwananyamala Regional Referral Hospital, Dar es Salaam, United Republic of Tanzania.
  • Hella J; Swiss Tropical and Public Public Health Institute, Allschwil, Switzerland.
  • Gingo W; University of Basel, Basel, Switzerland.
  • Sasamalo M; Ifakara Health Institute, Ifakara, United Republic of Tanzania.
  • Mnzava D; Saint Francis Referral Hospital, Ifakara, United Republic of Tanzania.
  • Kimera N; Ifakara Health Institute, Ifakara, United Republic of Tanzania.
  • Hiza H; Mwananyamala Regional Referral Hospital, Dar es Salaam, United Republic of Tanzania.
  • Wigayi J; Ifakara Health Institute, Ifakara, United Republic of Tanzania.
  • Mapesi H; Ifakara Health Institute, Ifakara, United Republic of Tanzania.
  • Kato IB; Saint Francis Referral Hospital, Ifakara, United Republic of Tanzania.
  • Mhimbira F; Ifakara Health Institute, Ifakara, United Republic of Tanzania.
  • Reither K; Ifakara Health Institute, Ifakara, United Republic of Tanzania.
  • Battegay M; Ifakara Health Institute, Ifakara, United Republic of Tanzania.
  • Paris DH; Ifakara Health Institute, Ifakara, United Republic of Tanzania.
  • Weisser M; Swiss Tropical and Public Public Health Institute, Allschwil, Switzerland.
  • Rohacek M; University of Basel, Basel, Switzerland.
Clin Infect Dis ; 76(6): 1013-1021, 2023 03 21.
Article in En | MEDLINE | ID: mdl-36331957
BACKGROUND: Patients with suspected extrapulmonary tuberculosis are often treated empirically. We hypothesized that extended focused assessment with sonography for human immunodeficiency virus (HIV) and tuberculosis (eFASH), in combination with other tests, would increase the proportion of correctly managed patients with suspected extrapulmonary tuberculosis. METHODS: This trial in adults with suspected extrapulmonary tuberculosis was performed in a rural and an urban hospital in Tanzania. Participants were randomized 1:1 to intervention or routine care, stratified by site and HIV status. All participants underwent clinical evaluation, chest radiography, and testing with sputum Xpert MTB/RIF and urine Xpert MTB/RIF Ultra assays. The intervention was a management algorithm based on results of eFASH plus microbiology, adenosine deaminase (ADA), and chest radiography. The primary outcome was the proportion of correctly managed patients. The presence of positive microbiological or ADA results defined definite tuberculosis. An independent end-point review committee determined diagnoses of probable or no tuberculosis. We evaluated outcomes using logistic regression models, adjusted for randomization stratification factors. RESULTS: From September 2018 to October 2020, a total of 1036 patients were screened and 701 were randomized (350 to the intervention and 351 to the control group). Of participants in the intervention group, 251 (72%) had a positive eFASH outcome. In 258 (74%) of the intervention and 227 (65%) of the control participants antituberculosis was initiated treatment at baseline. More intervention participants had definite tuberculosis (n = 124 [35%]), compared with controls (n = 85 [24%]). There was no difference between groups for the primary outcome (intervention group, 266 of 286 [93%]; control group, 245 of 266 [92%]; odds ratio, 1.14 [95% confidence interval: .60-2.16]; P = .68). There were no procedure-associated adverse events. CONCLUSIONS: eFASH did not change the proportion of correctly managed patients but increased the proportion of those with definite tuberculosis. CLINICAL TRIALS REGISTRATION: Pan African Registry: PACTR201712002829221.
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Full text: 1 Collection: 01-internacional Health context: 1_ASSA2030 / 2_ODS3 / 3_ND Database: MEDLINE Main subject: Tuberculosis / HIV Infections / Tuberculosis, Extrapulmonary Type of study: Clinical_trials / Prognostic_studies Limits: Adult / Humans Country/Region as subject: Africa Language: En Journal: Clin Infect Dis Year: 2023 Document type: Article

Full text: 1 Collection: 01-internacional Health context: 1_ASSA2030 / 2_ODS3 / 3_ND Database: MEDLINE Main subject: Tuberculosis / HIV Infections / Tuberculosis, Extrapulmonary Type of study: Clinical_trials / Prognostic_studies Limits: Adult / Humans Country/Region as subject: Africa Language: En Journal: Clin Infect Dis Year: 2023 Document type: Article