CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 290 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02659566
NCT02659566N/ACompleted

Impact of Antimalarial Treatment on Measures of T Cell Suppression/Regulation in Healthy Adults From Ouelessebougou, Mali

National Institute of Allergy and Infectious Diseases (NIAID)·observational·Posted Jan 20, 2016·Updated Jun 14, 2018

In Brief

An observational study for Malaria. Completed, enrolled 290 participants across 1 site.

Detailed Summary

Background: Malaria is a disease that affects many people in the country of Mali and other parts of Africa. It is caused by germs that are spread by mosquito bites. Malaria may be mild, but can also be serious or can lead to death if not diagnosed and treated promptly. Children younger than 5 years and pregnant women are at highest risk of malaria. Researchers want to better understand how malaria infection suppresses the immune system. They want to compare a group of adults who receive antimalarial treatment to a group that does not receive it. Objective: To investigate the effect of antimalarial treatment at the beginning of the dry season on the immune system and malaria episodes. Eligibility: Healthy adults ages 18-60 who live in the area of Doneguebougou, Mali. Design: Participants will be screened with a physical exam and health questions. If participants are found to be sick at the screening visit, they will get initial care at the study clinic free of charge. They may get referrals for consultation. Participants will be randomly assigned to a group. One group will get an approved antimalarial drug called Coartem . The other will not receive it. Participants in the Coartem group will take the drug for 3 days. All participants will have blood tests. Al participants will be seen about once a month for about 1 year. At each visit, they will be asked how they are feeling and be examined. Blood will be drawn. If participants become sick at any time, they will come to the clinic to be examined.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesMali
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 20, 2016
Enrollment StartJan 15, 2016
Primary CompletionJun 12, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.5 years ago