The usefulness of whole genome sequencing in diagnosis and clinical management of drug-resistant tuberculosis patients in Tanzania

Clinical application of whole genome sequencing in multidrug-resistant tuberculosis patients in Tanzania

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN14635089

Enrollment

153

Registered

2024-03-06

Start date

2021-10-01

Completion date

Unknown

Last updated

2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Application of whole genome sequencing in multidrug resistance tuberculosis patients Infections and Infestations

Interventions

This study is an observational clinical trial focusing on multidrug-resistant tuberculosis (MDRTB) patients at Kibong’oto Infectious Diseases Hospital in Moshi, Tanzania. The objective is to assess th

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. TB patients aged =18 years 2. Confirmed either as MDR-TB or non MDRTB using DST, Xpert® MTB/RIF assay GeneXpert® (Cepheid, Sunnyvale, CA, USA), GenoType MTBDRplus (Hain Life science, GmbH, Nehren) 3. Willingness to sign a written informed consent and provide sputum samples for laboratory analysis.

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
The efficacy of the diagnostic tests including drug susceptibility testing (DST), line probe assay and GeneXpert measured against the Gold standard (Culture).	—

Secondary

Measure	Time frame
Whole genome diagnostic efficacy will be measured against the gold standard test (culture). The measurement will be sensitivity and specificity.	—

Countries

Tanzania

Contacts

Public ContactBugwesa;Bugwesa Katale;Katale

;

zablon.bugwesa@sacids.org;bugwesa.katale@costech.or.tz+255 784687178;+255784687178

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 23, 2026