TuberculosisMaTuTUNCT02156882
Establishment of a Clinical Trial Unit in Mavalane, Maputo, in Mozambique
An observational study of Tuberculosis, run by Michael Hoelscher at 2 sites in Mozambique.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- How many people
- 81 participants
- Where
- 2 sitesMozambique
- Study dates
- Jun 2014to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: TB patients and TB suspects who present themselves or are referred to theTB clinic at the Mavalane Health center
Who may be able to join
- >/= 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
Who cannot join
- 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%
Trial locations and contacts
2 sites in 1 country.
Mozambique2 sites
Centro de Investigação e Treino em Saúde da Polana Caniço
Maputo, PO.BOX 264
Instituto Nacional de Saúde, Eduardo Mondlane Avenue nº 1008 MISAU
Maputo
About this study
Official title: Maputo Tuberculosis Trial Unit- Project (MaTuTU- Project)
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.
Read the detailed description
Main study objective:
To assess the feasibility to perform a TB clinical trial in Maputo, Mozambique, by screening, examining,enrollment, follow-up and data collection of TB patients sent for TB treatment as well as TB suspects who are sent for smear microscopy to the TB clinic at the Mavalane health center.
Screening of study patients:
After consenting, each study participant (with confirmed or suspected TB) will be screened for TB with smear microscopy after Ziehl-Neelsen staining and Xpert MTB/RIF assay. In patients with signs of extrapulmonary TB manifestation, specimen collection other than sputum are to be decided by the treating physician in the patient' s best interest, to establish TB diagnosis by using smear microscopy and/or Xpert MTB/RIF assay. Patients without a positive Xpert MTB/RIF-assay result will not continue in the study but will be referred to the National TB Program for further evaluation and treatment. In patients with a positive Xpert MTB/RIF result in any specimen anti TB treatment will be commenced according to the National Guidelines. All TB positive study participants will be followed up until 6 months after TB treatment initiation.
Study methods:
Follow up visits will occur at week 1, 2, 4, 8, 12, 17 and 26 after commencement of TB therapy. An optional visit will be performed in selected patients at week 52 in order to confirm cure of TB disease. At each study visit, a clinical investigation will be performed and a medical questionnaire will be completed for each participant. Further, sputum and urine samples will be collected for the evaluation of the new TB diagnostics. A chest x-ray will be performed and blood for HIV testing, CD4 count, biochemistry and full blood picture will be collected at baseline only or when medically indicated during the course of the study.
Data recording and analysis:
The study will follow ethical principles as outlined in the declaration of Helsinki and its revisions (last in 2008) and will be performed in compliance with the guidelines of Good Clinical, Laboratory (GCLP) and Clinical Data Management Practice (GCDMP). All essential documents will be archived for 3 years. All patient information will be treated in a strictly confidential manner and will be linked to a unique ID number and not to personal identifiers. Data will be collected on paper CRFs, which will be entered into a secured clinical data management system, for which daily backups will be done. Double data entry will minimize data entry errors, and full data validation and cleaning process will be employed.
- Conditions
- Tuberculosis
- Keywords
- TB, Tuberculosis, MaTuTU - Maputo Tuberculosis Trial Unit, Clinical Trial Capacity Development
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TB patients and Tb suspects | Patients with confirmed tuberculosis who are treated by the National TB Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinical and microbiological cure at month 6 after treatment initiation
Measured: 52 weeks in those patients which were enrolled until December 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Hoelscher
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Hoelscher, Ludwig-Maximilians - University of Munich
- Investigators
- Nilesh Bhatt, MD, MMED, Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156882
- Sponsor's protocol ID
- MaTuTU-TB-01
- Acronym
- MaTuTU
- Status last verified
- Mar 2018
- First submitted
- 4 Jun 2014
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maputo Tuberculosis Trial Unit- Project (MaTuTU- Project)
- ClinicalTrials.gov ID
- NCT02156882
- Acronym / sponsor ID
- MaTuTU / MaTuTU-TB-01
- Conditions
- Tuberculosis
- Keywords
- TB, Tuberculosis, MaTuTU - Maputo Tuberculosis Trial Unit, Clinical Trial Capacity Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Michael HoelscherUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Main study objective:
To assess the feasibility to perform a TB clinical trial in Maputo, Mozambique, by screening, examining,enrollment, follow-up and data collection of TB patients sent for TB treatment as well as TB suspects who are sent for smear microscopy to the TB clinic at the Mavalane health center.
Screening of study patients:
After consenting, each study participant (with confirmed or suspected TB) will be screened for TB with smear microscopy after Ziehl-Neelsen staining and Xpert MTB/RIF assay. In patients with signs of extrapulmonary TB manifestation, specimen collection other than sputum are to be decided by the treating physician in the patient' s best interest, to establish TB diagnosis by using smear microscopy and/or Xpert MTB/RIF assay. Patients without a positive Xpert MTB/RIF-assay result will not continue in the study but will be referred to the National TB Program for further evaluation and treatment. In patients with a positive Xpert MTB/RIF result in any specimen anti TB treatment will be commenced according to the National Guidelines. All TB positive study participants will be followed up until 6 months after TB treatment initiation.
Study methods:
Follow up visits will occur at week 1, 2, 4, 8, 12, 17 and 26 after commencement of TB therapy. An optional visit will be performed in selected patients at week 52 in order to confirm cure of TB disease. At each study visit, a clinical investigation will be performed and a medical questionnaire will be completed for each participant. Further, sputum and urine samples will be collected for the evaluation of the new TB diagnostics. A chest x-ray will be performed and blood for HIV testing, CD4 count, biochemistry and full blood picture will be collected at baseline only or when medically indicated during the course of the study.
Data recording and analysis:
The study will follow ethical principles as outlined in the declaration of Helsinki and its revisions (last in 2008) and will be performed in compliance with the guidelines of Good Clinical, Laboratory (GCLP) and Clinical Data Management Practice (GCDMP). All essential documents will be archived for 3 years. All patient information will be treated in a strictly confidential manner and will be linked to a unique ID number and not to personal identifiers. Data will be collected on paper CRFs, which will be entered into a secured clinical data management system, for which daily backups will be done. Double data entry will minimize data entry errors, and full data validation and cleaning process will be employed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TB patients and Tb suspects | – | –Patients with confirmed tuberculosis who are treated by the National TB Programme |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- TB patients and TB suspects who present themselves or are referred to theTB clinic at the Mavalane Health center
Key inclusion criteria (3 listed)
- >/= 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
Key exclusion criteria (4 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilesh Bhatt, MD, MMED principal investigator
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Michael Hoelscher at 2 sites in Mozambique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.