Clinical Trial: Concomitant Infections of Mansonella Perstans in Tuberculosis and Buruli Ulcer Disease Patients From Ghana

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparison of Early and Late Administration of Doxycycline in Their Efficacy Against Mansonella Perstans and in Development of Immunity Against Mycobacterial Infections

Brief Summary: 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.

Detailed Summary:

The purpose of this study is to describe the immune response to Mansonella perstans with or without doxycycline treatment. And to suggest the use of doxycycline for the treatment of Mansonella perstans infected individuals. Two hundred Mansonella perstans infected individuals who are contacts of patients with Buruli ulcer or Tuberculosis will be recruited and placed in two groups. Hundred patients in each group ('early', or 'delayed' doxycycline-treatment group) with weight 40kg and above. Individuals will be recruited from communities in the Asante Akim North District.

Half of the M. perstans infected individuals (randomly selected) will be treated immediately with 200mg daily doxycycline for six weeks. All recruited individuals will be asked to donate 20ml; 10 ml heparinized blood, 5ml Ethylenediaminetetraacetic acid blood and 5ml blood for serum analysis at baseline (day 0), after 4 months (day 112), after 12 months (day 336) and after 24 months (day 672). Six months after doxycycline treatment for M. perstans infected individuals the other 100 patients who are not treated at time point 0 (delayed' treatment group) will be treated as described for the 'early' treatment group. After four months (day 112) individuals from both treatment groups will be asked to donate blood for quantitative Polymerase Chain Reaction to confirm Wolbachia depletion and immunological analyses.

For 'early', and 'delayed', doxycycline-treatment group immunological assays will be performed at days 0, 112, 336 and 672 after treatment initiation for all recruited individuals.

Hypothesis:

Presence of filarial nematodes Mansonella perstans will polarize the host immunity towards humoral and T helper type 2-mediated immunity and treatment with doxycycl
Sponsor: Kwame Nkrumah University of Science and Technology

Current Primary Outcome: Microfilarial assessment [ Time Frame: Change from baseline microfilarial load at 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Demonstrate development of a T helper type 1 immunity through Immunological profile of cellular immune responses [ Time Frame: Change from baseline T helper type 1 cytokine levels at 24 weeks ]

Original Secondary Outcome: Same as current

Information By: Kwame Nkrumah University of Science and Technology

Dates:
Date Received: October 26, 2014
Date Started: October 2014
Date Completion:
Last Updated: March 22, 2017
Last Verified: March 2017