Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
12 December 2020 |
Main ID: |
NCT02156882 |
Date of registration:
|
04/06/2014 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Establishment of a Clinical Trial Unit in Mavalane, Maputo, in Mozambique
MaTuTU |
Scientific title:
|
Maputo Tuberculosis Trial Unit- Project (MaTuTU- Project) |
Date of first enrolment:
|
June 2014 |
Target sample size:
|
81 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT02156882 |
Study type:
|
Observational |
Study design:
|
|
Phase:
|
|
|
Countries of recruitment
|
Mozambique
| | | | | | | |
Contacts
|
Name:
|
Nilesh Bhatt, MD, MMED |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Centro de Investigação e Treino em Saúde da Polana Caniço, Costa do Sol Street, nº 178, PO.BOX 264 Polana Caniço B neighborhood Maputo, Mozambique |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- >/= 18 years old
- Able and willing to give informed consent to study participation, including
HIV-testing
- Positive TB result by Xpert MTB/RIF performed at the study clinic
Exclusion Criteria:
- TB treatment in the last 6 months
- Abandoned TB treatment at any time point in the past
- Suffering from a condition likely to lead to uncooperative behaviour e.g. psychiatric
illness or alcoholism.
- Karnofsky index below 50%
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Tuberculosis
|
Primary Outcome(s)
|
Number of participants with clinical and microbiological cure at month 6 after treatment initiation
[Time Frame: 52 weeks in those patients which were enrolled until December 2014]
|
Secondary ID(s)
|
MaTuTU-TB-01
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|