The usefulness of whole genome sequencing in diagnosis and clinical management of drug-resistant tuberculosis patients in Tanzania
| ISRCTN | ISRCTN14635089 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14635089 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | NIMR/HQ/R.8a/Vol.IX/3600 |
| Sponsor | Tanzania Commission for Science and Technology |
| Funder | European and Developing Countries Clinical Trials Partnerships |
- Submission date
- 10/11/2023
- Registration date
- 06/03/2024
- Last edited
- 06/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Drug-resistant tuberculosis (DR-TB) poses a significant challenge to global tuberculosis (TB) control efforts. Whole genome sequencing (WGS) which is based on genetic change of the TB causing bacteria (Mycobacterium tuberculosis) has been used in diagnosis and management of drug resistance TB patients in developed countries, but its incorporation into the detection of TB in developing countries is limited due to lack of expertise and financial capabilities. This study aims to determine the usefulness of WGS in detection and management of TB patients by comparing with currently used diagnostic tests such as growth of bacterial causing TB disease, GeneXpert test (currently used detection test for TB diagnosis in health centers).
Who can participate?
The participation in the study is voluntary and will involve TB patients who do not respond to treatments of at least isoniazid and rifampin, the two most potent TB drugs.
What does the study involve?
Patients receive treatments as per guidelines for the management of the disease in the country.
What are the possible benefits and risks of participating?
The study is non-invasive; hence risk is minimal based on the fact that only sputum sample on the spot is routinely required at the health centre.
Where is the study run from?
Tanzania Commission for Science and Technology in collaboration with Muhimbili University of Health and Allied Sciences and Kibong'oto Infectious Diseases Hospital, Moshi, Kilimanjaro region in the United Republic of Tanzania.
When is the study starting and how long is it expected to run for?
October 2020 to October 2024
Who is funding the study?
European and Developing Countries Clinical Trials Partnerships (EDCTP)
Who is the main contact?
Dr Bugwesa Katale
bugwesa2002@yahoo.co.uk
zablon.bugwesa@sacids.org
bugwesa.katale@costech.or.tz
Contact information
Public, Scientific, Principal investigator
Tanzania Commission for Science and Technology, P.O. BOX 4302
Dar es Salaam
14113
Tanzania
 ORCID ID |
0000-0002-3276-2603 |
|---|---|
| Phone | +255 784687178 |
| zablon.bugwesa@sacids.org |
Public, Scientific, Principal investigator
Tanzania Commission for Science and Technology, P.O. BOX 4302
Dar es Salaam
14113
Tanzania
| Phone | +255784687178 |
|---|---|
| bugwesa.katale@costech.or.tz |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cross sectional |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Clinical application of whole genome sequencing in multidrug-resistant tuberculosis patients in Tanzania |
| Study acronym | CWGSMDRT-TB |
| Study objectives | Whole genome sequencing of DR TB strains will improve the diagnosis and treatment of TB in Tanzania while providing stringent strain discrimination. |
| Ethics approval(s) |
Approved 01/10/2020, National health Research Ethics Committee (NaTHREC) (3 Baraka Obama Drive, P.O. BOX 9653, 11101, Dar es Salaam, 12101, Tanzania; +255 222121400; hq@nimr.or.tz), ref: NIMR/HQ/R.8b/Vol.I/1099, 2021-617-NA-2021/109 |
| Health condition(s) or problem(s) studied | Application of whole genome sequencing in multidrug resistance tuberculosis patients |
| Intervention | 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 the efficacy of whole genome sequencing (WGS) in comparison to the existing diagnostic methods for detecting MDRTB in the country. The participants in the trial will be MDRTB patients attending tuberculosis (TB) clinics, who have been initially diagnosed using Xpert MTB/RIF and subsequently confirmed through Line Probe Assays (LPA), specifically the GenoType MTBDRplus. Every second MDRTB patient seeking health services at the clinic will be included in the study. The evaluation will involve comparing WGS with the current diagnostic tests, including culture, drug susceptibility testing, and GeneXpert. The goal is to determine the utility and effectiveness of WGS in detecting multidrug resistance in tuberculosis patients as compared to the standard diagnostic procedures currently in use. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Illumina hiseq |
| Primary outcome measure(s) |
The efficacy of the diagnostic tests including drug susceptibility testing (DST), line probe assay and GeneXpert measured against the Gold standard (Culture). |
| Key secondary outcome measure(s) |
Whole genome diagnostic efficacy will be measured against the gold standard test (culture). The measurement will be sensitivity and specificity. |
| Completion date | 01/11/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 153 |
| Key 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. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/10/2021 |
| Date of final enrolment | 01/11/2024 |
Locations
Countries of recruitment
- Tanzania
Study participating centre
Dar es Salaam
25101
Tanzania
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| IPD sharing plan | The dataset generated from the study will be stored at Tanzania Commission for Science and Technology repository and shared upon request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/11/2023: Trial's existence confirmed by National health Research Ethics Committee (NaTHREC)
