- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02281643
Concomitant Infections of Mansonella Perstans in Tuberculosis and Buruli Ulcer Disease Patients From Ghana (Map2Co)
Comparison of Early and Late Administration of Doxycycline in Their Efficacy Against Mansonella Perstans and in Development of Immunity Against Mycobacterial Infections
Study Overview
Status
Intervention / Treatment
Detailed Description
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 doxycycline will result in killing of Wolbachia endosymbionts, depletion of Mansonella perstans and development of a T helper type 1 immunity and reduced risk of developing Tuberculosis and Buruli ulcer
Sample size justification Since the study is a pilot study to gain first experience regarding the primary and secondary endpoints under the intended treatment regimens, the sample size cannot be justified by a statistical argumentation. A sample size of 100 participants (80 participants plus 20% drop-out rate) per treatment arm was chosen in agreement with the study statistician.
Statistical methods The detailed plan for data analysis will be written and discussed with the DMEC before final de-blinding of the data.
Data safety Electronic data will be secured and password limited to persons named in this Study Protocol. Analyses of the data will be performed on copies of the original data files ensuring raw data accessibility at all times. Regular backups to an external hard drive will be carried out ensuring protection against data loss.
Data Monitoring and Ethics Committee (DMEC) Independent monitoring of the clinical trial will be carried out by the DMEC consisting of representatives from key stakeholders in existing filarial control programmes with the necessary expertise covering the range of project activities and skills to provide support and advice on the study progress.
Additionally the External Scientific Advisory Committee (ESAC) will monitor the study ensuring compliance with all directives. DMEC and ESAC members are listed
Informed Consent Form (ICF) Regulatory requirement necessitates obtaining and documenting informed consent, Good Clinical Practice and ethical principles along the Declaration of Helsinki (first adopted 1964, amended five times, most recently in 2000). All consent forms will accompany the study protocol and submitted for approval by the relevant ethic committees.
Patient insurance Professional indemnity liability insurance of the individual volunteers will be obtained to take care of any form of injuries that may arise in the process of drug administration.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Asante Akim North District
-
Agogo, Asante Akim North District, Ghana
- Agogo Presbyterian Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Early doxycycline administered
Early doxycycline administered - volunteers will be treated immediately with 200mg daily doxycycline for 6 weeks
|
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
|
200mg oral doxycycline will be administered immediately (early) in the experimental arm or delayed in the comparator arm
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microfilarial assessment
Time Frame: Change from baseline microfilarial load at 12 months
|
Assessment of the microfilarial load
|
Change from baseline microfilarial load at 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from baseline T helper type 1 cytokine levels at 24 weeks
|
Collaborators and Investigators
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Disease Attributes
- Skin Ulcer
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Parasitic Diseases
- Mycobacterium Infections
- Spirurida Infections
- Secernentea Infections
- Nematode Infections
- Helminthiasis
- Mycobacterium Infections, Nontuberculous
- Filariasis
- Ulcer
- Infections
- Communicable Diseases
- Tuberculosis
- Coinfection
- Dipetalonema Infections
- Acanthocheilonemiasis
- Mansonelliasis
- Buruli Ulcer
- Anti-Infective Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Doxycycline
Other Study ID Numbers
- GZ:JA 1479/5-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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