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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: Michael Hoelscher
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
Intervention(s)
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 Outcome(s)
Secondary ID(s)
MaTuTU-TB-01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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