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

NCT02659566 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 290

Last updated 2018-06-14

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Michal Fried, Ph.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-15
Primary Completion
2018-06-12
Completion
2018-06-12

Countries

  • Mali

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02659566 on ClinicalTrials.gov