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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02281643
• Date of registration: 26/10/2014
• Prospective Registration: No
• Primary sponsor: Kwame Nkrumah University of Science and Technology
• Public title: Concomitant Infections of Mansonella Perstans in Tuberculosis and Buruli Ulcer Disease Patients From Ghana Map2Co
• Scientific title: Comparison of Early and Late Administration of Doxycycline in Their Efficacy Against Mansonella Perstans and in Development of Immunity Against Mycobacterial Infections
• Date of first enrolment: October 2014
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02281643
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Ghana

Contacts

• Name: Alexander Y Debrah, PhD
• Affiliation: Kwame Nkrumah University of Science and Technology

• Name: Richard Phillips O Phillips, MBChB, PhD
• Affiliation: Kwame Nkrumah University of Science and Technology

• Name: Ellis Owusu Dabo, MBChB, PhD
• Affiliation: Kumasi Centre for Collaborative Research

Key inclusion & exclusion criteria

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



Age minimum: 9 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Buruli Ulcer

Co-infection

Tuberculosis

Mansonella Perstans Infection

Intervention(s)

Drug: Doxycycline

Primary Outcome(s)

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

Secondary Outcome(s)

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]

Secondary ID(s)

GZ:JA 1479/5-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Bonn

Heinrich-Heine University, Duesseldorf