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Concomitant Infections of Mansonella Perstans in Tuberculosis and Buruli Ulcer Disease Patients From Ghana (Map2Co)

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ClinicalTrials.gov Identifier: NCT02281643
Recruitment Status : Completed
First Posted : November 3, 2014
Last Update Posted : March 23, 2017
Sponsor:
Collaborators:
University of Bonn
Heinrich-Heine University, Duesseldorf
Information provided by (Responsible Party):
Dr Richard Phillips, Kwame Nkrumah University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Mansonella Perstans Infection Buruli Ulcer Tuberculosis Co-infection Drug: Doxycycline Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Early and Late Administration of Doxycycline in Their Efficacy Against Mansonella Perstans and in Development of Immunity Against Mycobacterial Infections
Study Start Date : October 2014
Actual Primary Completion Date : March 15, 2017
Actual Study Completion Date : March 15, 2017


Arm Intervention/treatment
Experimental: Early doxycycline administered
Early doxycycline administered - volunteers will be treated immediately with 200mg daily doxycycline for 6 weeks
Drug: Doxycycline
200mg oral doxycycline will be administered immediately (early) in the experimental arm or delayed in the comparator arm
Other Names:
  • Vibramycim
  • Oracea

Active Comparator: Delayed doxycycline administered
Delayed doxycycline administered-volunteers will be treated six months after the early group has received treatment with 200mg daily doxycycline for 6 weeks
Drug: Doxycycline
200mg oral doxycycline will be administered immediately (early) in the experimental arm or delayed in the comparator arm
Other Names:
  • Vibramycim
  • Oracea




Primary Outcome Measures :
  1. Microfilarial assessment [ Time Frame: Change from baseline microfilarial load at 12 months ]
    Assessment of the microfilarial load


Secondary Outcome Measures :
  1. 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 ]
    Measurement of the T helper type 1 cytokine levels



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Ages Eligible for Study:   9 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281643


Locations
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Ghana
Agogo Presbyterian Hospital
Agogo, Asante Akim North District, Ghana
Sponsors and Collaborators
Kwame Nkrumah University of Science and Technology
University of Bonn
Heinrich-Heine University, Duesseldorf
Investigators
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Principal Investigator: Richard Phillips O Phillips, MBChB, PhD Kwame Nkrumah University of Science and Technology
Study Director: Ellis Owusu Dabo, MBChB, PhD Kumasi Centre for Collaborative Research
Study Chair: Alexander Y Debrah, PhD Kwame Nkrumah University of Science and Technology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Richard Phillips, Dr, Kwame Nkrumah University of Science and Technology
ClinicalTrials.gov Identifier: NCT02281643     History of Changes
Other Study ID Numbers: GZ:JA 1479/5-1
First Posted: November 3, 2014    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017
Keywords provided by Dr Richard Phillips, Kwame Nkrumah University of Science and Technology:
Coinfection
Buruli ulcer
Tuberculosis
Mansonella perstans
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Tuberculosis
Coinfection
Buruli Ulcer
Dipetalonema Infections
Acanthocheilonemiasis
Mansonelliasis
Ulcer
Pathologic Processes
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Virus Diseases
Parasitic Diseases
Mycobacterium Infections, Nontuberculous
Skin Ulcer
Skin Diseases
Filariasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents