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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02659566 |
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Date of registration:
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15/01/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Impact of Antimalarial Treatment on Measures of T Cell Suppression/Regulation in Healthy Adults From Doneguebougou, Mali
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Scientific title:
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Impact of Antimalarial Treatment on Measures of T Cell Suppression/Regulation in Healthy Adults From Ouelessebougou, Mali |
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Date of first enrolment:
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January 15, 2016 |
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Target sample size:
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290 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02659566 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Mali
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Contacts
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Name:
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Michal Fried, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institute of Allergy and Infectious Diseases (NIAID) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
A study participant must satisfy the following criteria to be enrolled in this study:
- Provide individual informed consent
- Adult between ages of 18 and 60
- Willingness to have blood samples stored for future research
- Known resident of Ouelessebougou or surrounding area
EXCLUSION CRITERIA:
A subject will be excluded from participating in this trial if any one of the following
criteria is fulfilled:
- Known to be pregnant (by history) or positive pregnancy test
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine,
rheumatologic, autoimmune, hematological, oncologic, psychiatric, or renal disease by
history and/or physical examination that may impact the subject s overall health and
immune system
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator
affects the ability of the participant to understand and comply with the study
protocol
- Use of chronic (greater than or equal to14 days) oral or intravenous corticosteroids
(excluding topical or nasal) at immunosuppressive doses (i.e., prednisone >10 mg/day)
or immunosuppressive drugs within 30 days of Study Day 0
- Receipt of Coartem within less than 14 days from Study Day 0
- Known allergies or contraindications (such as significant cardiac disease prolonged
QTc >450 ms; currently taking medications that may prolong your QTc; serious side
effects from Coartem in the past) to study treatment (Coartem
[artemether/lumefantrine])
- Receipt of investigational malaria vaccine within the last 5 years
- Enrollment in another investigational trial during the study period (participating in
screening for other investigational trials is permitted)
- Tested positive for HIV or Hepatitis B or Hepatitis C.
- Other condition that in the opinion of the investigator would jeopardize the safety or
rights of a participant participating in the trial, interfere with the evaluation of
the study objectives, or would render the subject unable to comply with the protocol
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malaria
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Primary Outcome(s)
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To measure the percentage of T cells expressing PD-1 during scheduled visits by comparing markers of T cell suppression/regulation in adults (specifically PD-1) who receive or do not receive antimalarial treatment at the beginning of dry season ...
[Time Frame: Twelve months]
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Secondary ID(s)
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999916051
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16-I-N051
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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