Establishment of a Clinical Trial Unit in Mavalane, Maputo, in Mozambique
MaTuTU
Maputo Tuberculosis Trial Unit- Project (MaTuTU- Project)
1 other identifier
observational
81
1 country
2
Brief Summary
In this longitudinal study with a follow up time of at least 6 months, up to 300 tuberculosis (TB) patients or TB suspects will be screened for TB using the Xpert MTB/RIF assay along with standard smear microscopy after Ziehl-Neelsen staining at the TB health clinic located at Mavalane health center. Confirmed TB cases will be followed up during TB therapy until month six after treatment initiation in order to obtain clinical and microbiological data on treatment including treatment response. Apart from relevant research questions in the field of TB diagnostics and treatment, the main objective of this study will be the development of a clinical TB research site, including capacity development in clinical and laboratory based TB research methods, in Mavalane, Maputo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2014
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 4, 2014
CompletedFirst Posted
Study publicly available on registry
June 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedMarch 7, 2018
March 1, 2018
1.9 years
June 4, 2014
March 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with clinical and microbiological cure at month 6 after treatment initiation
52 weeks in those patients which were enrolled until December 2014
Study Arms (1)
TB patients and Tb suspects
Patients with confirmed tuberculosis who are treated by the National TB Programme
Eligibility Criteria
TB patients and TB suspects who present themselves or are referred to theTB clinic at the Mavalane Health center
You may qualify if:
- \>/= 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
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centro de Investigação e Treino em Saúde da Polana Caniço
Maputo, PO.BOX 264, Mozambique
Instituto Nacional de Saúde, Eduardo Mondlane Avenue nº 1008 MISAU
Maputo, Mozambique
Biospecimen
Sputum, Urine, Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nilesh Bhatt, MD, MMED
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
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
June 4, 2014
First Posted
June 5, 2014
Study Start
June 1, 2014
Primary Completion
May 1, 2016
Study Completion
September 1, 2016
Last Updated
March 7, 2018
Record last verified: 2018-03