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Trial record 2 of 5 for:
"Acanthocheilonemiasis"
Concomitant Infections of Mansonella Perstans in Tuberculosis and Buruli Ulcer Disease Patients From Ghana (Map2Co)
This study has been completed.
Sponsor:
Kwame Nkrumah University of Science and Technology
Collaborators:
University of Bonn
Heinrich-Heine University, Duesseldorf
Information provided by (Responsible Party):
Dr Richard Phillips, Kwame Nkrumah University of Science and Technology
ClinicalTrials.gov Identifier:
NCT02281643
First received: October 26, 2014
Last updated: March 22, 2017
Last verified: March 2017
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Mansonella Perstans Infection Buruli Ulcer Tuberculosis Co-infection | Drug: Doxycycline | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: No masking 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Tuberculosis
Drug Information available for:
Doxycycline
Doxycycline monohydrate
Doxycycline hyclate
Doxycycline calcium
Genetic and Rare Diseases Information Center resources:
Tuberculosis
Acanthocheilonemiasis
Buruli Ulcer
Mansonelliasis
Lymphatic Filariasis
Helminthiasis
U.S. FDA Resources
Further study details as provided by Dr Richard Phillips, Kwame Nkrumah University of Science and Technology:
Primary Outcome Measures:
- Microfilarial assessment [ Time Frame: Change from baseline microfilarial load at 12 months ]Assessment of the microfilarial load
Secondary Outcome Measures:
- 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
| Enrollment: | 200 |
| Study Start Date: | October 2014 |
| Study Completion Date: | March 15, 2017 |
| Primary Completion Date: | March 15, 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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:
|
Show Detailed Description
Eligibility| 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02281643
Please refer to this study by its ClinicalTrials.gov identifier: NCT02281643
Locations
| 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
| 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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| Study First Received: | October 26, 2014 |
| Last Updated: | March 22, 2017 |
Keywords provided by Dr Richard Phillips, Kwame Nkrumah University of Science and Technology:
|
Coinfection Buruli ulcer Tuberculosis Mansonella perstans |
Additional relevant MeSH terms:
|
Dipetalonema Infections Acanthocheilonemiasis Infection Communicable Diseases Ulcer Tuberculosis Coinfection Buruli Ulcer Mansonelliasis 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 |
ClinicalTrials.gov processed this record on July 11, 2017