- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04547738
Influence of Filarial Infections on Tuberculosis Disease and Tuberculosis Vaccination in Cameroon (MAP-TB)
Mansonella Perstans Effects on BCG Vaccine-induced Protection Against Childhood Tuberculosis (TB) as Well as TB Disease Severity and Recovery in Cameroon (MAP-TB)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Samuel Wanji, Prof. Dr.
- Phone Number: +237 77 72 43 84
- Email: swanji@yahoo.fr
Study Contact Backup
- Name: Manuel Ritter, Dr.
- Phone Number: +4928828711453
- Email: manuel.ritter@ukbonn.de
Study Locations
-
-
-
Buea, Cameroon
- Recruiting
- University of Buea
-
Contact:
- Samuel Wanji
- Phone Number: +237694727715
- Email: samwandji@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- TB positive individuals (older than 5 years)
- TB contacts (children 5-17 years old)
Description
Inclusion Criteria:
- Patient is older than 5 years old
- Patient have BCG scare or get the BCG vaccination at birth
- Patient had no previous treatment of, tuberculosis or with at least one of the study drugs i.e. isoniazid,rifampicin, pyraziamide, ethambutol
- Patient have no history of hypersensitivity to rifampicin, or any of the above mentioned drugs
- Patient is not on any medication likely to interact with the study medication
- Patient have no history of or current clinical signs of ascites, jaundice, partial or complete deafness, myasthenia gravis, renal dysfunction (known or suspected), diabetes mellitus, and severe immune compromise (e.g., immunosuppressive drugs after organ transplant), or have no evidence of (previous) tuberculosis, Buruli ulcer or leprosy and no terminal illness (e.g., metastasized cancer)
- Patient have no mental condition
- Patient is able to take oral medication
- Patient have no mental condition including addiction with substance abuse e.g. alcohol
- Patient is willing to give informed pre-consent, and consent
- In case the patient is below 18, the parents or legal guardians were informed and provide consent
Exclusion Criteria:
- Patient is younger than 5 years old
- Patient have no BCG scare or miss the BCG vaccination at birth
- Patient had previous treatment of, tuberculosis or with at least one of the study drugs i.e. isoniazid,rifampicin, pyraziamide, ethambutol
- Patient have a history of hypersensitivity to rifampicin, or any of the above mentioned drugs
- Patient is on any medication likely to interact with the study medication
- Patient have a history of or current clinical signs of ascites, jaundice, partial or complete deafness, myasthenia gravis, renal dysfunction (known or suspected), diabetes mellitus, and severe immune compromise (e.g., immunosuppressive drugs after organ transplant), or evidence of (previous) tuberculosis, Buruli ulcer or leprosy; or terminal illness (e.g., metastasized cancer)
- Patient have a mental condition including addiction with substance abuse e.g. alcohol likely to interfere with possibility to comply with study protocol
- Patient is unable to take oral medication or having gastrointestinal disease likely to interfere with drug absorption
- Patient have a mental condition including addiction with substance abuse e.g. alcohol likely to interfere with possibility to comply with study protocol
- Patient is not willing to give informed pre-consent, and consent or withdrawal or consent
- In case the patient is below 18, were the parents or legal guardians were not informed and did not provide consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Tuberculosis (TB) index patients
- Patients (older than 5 years) diagnosed with TB before initiation of TB treatment
|
National clinics in Cameroon will initiate TB treatment according to national guidelines upon positive TB diagnosis
|
TB contacts
- Children (5-17 years old), who had contact with TB index patients
|
National clinics in Cameroon will initiate TB treatment according to national guidelines upon positive TB diagnosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Influence of filariae infection on TB disease outcome and BCG vaccination
Time Frame: 3 years
|
Does filarial infection influence tuberculosis disease severity and recovery under treatment and influence Bacille Calmette-Guérin (BCG)-induced protection against disease progression Parasitological diagnosis:
TB diagnosis:
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biomarkers for TB severity and BCG vaccination
Time Frame: 3 years
|
Decipher biomarker for TB disease severity and recovery under treatment and for prediction of BCG vaccine induced immune protection against development of TB Laboratory assessment: - CFP10/ESAT6 in vitro and TB-TAM assay from peripheral whole blood using flow cytometry technology |
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Achim Hoerauf, Prof. Dr., UKB, IMMIP
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HO2009/14-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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