Tuberculosis Clinical Trial
— Map2CoOfficial title:
Comparison of Early and Late Administration of Doxycycline in Their Efficacy Against Mansonella Perstans and in Development of Immunity Against Mycobacterial Infections
Verified date | March 2017 |
Source | Kwame Nkrumah University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will determine the influence of doxycycline treatment against Wolbachia/M. perstans on immunity against concomitant mycobacterial infections in healthy M. perstans infected individuals. In this regard, the investigators will perform a community-based randomized controlled trial (Phase 2a) in Asante Akim North District. A cohort of 200 participants who are contacts of patients with Tuberculosis or Buruli ulcer, of both sexes with no clinical condition requiring long-term medication but connected with Mansonella perstans will be investigated for the effect of doxycycline on microfilaria, the immune response and development of mycobacterial disease.
Status | Completed |
Enrollment | 200 |
Est. completion date | March 15, 2017 |
Est. primary completion date | March 15, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 9 Years to 55 Years |
Eligibility |
Inclusion Criteria: M. perstans mg-positive status Good general health without any clinical condition requiring long-term medication. Normal renal and hepatic laboratory profiles Exclusion Criteria: Known intolerance to the doxycycline Body weight <40 kg Pregnancy or breastfeeding History of severe allergic reaction or anaphylaxis Alcohol or drug abuse |
Country | Name | City | State |
---|---|---|---|
Ghana | Agogo Presbyterian Hospital | Agogo | Asante Akim North District |
Lead Sponsor | Collaborator |
---|---|
Kwame Nkrumah University of Science and Technology | Heinrich-Heine University, Duesseldorf, University of Bonn |
Ghana,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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Secondary | Demonstrate development of a T helper type 1 immunity through Immunological profile of cellular immune responses | Measurement of the T helper type 1 cytokine levels | Change from baseline T helper type 1 cytokine levels at 24 weeks |
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