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Impact of TMP-SMX Prophylaxis on Malaria Infection and Immunity in Children in Uganda

NCT02094508 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 173

Last updated 2018-04-05

No results posted yet for this study

Summary

Background:

\- Malaria is a disease that affects many children and adults in Uganda and Africa. If it is not treated, it can make some people severely ill. TMP-SMX (Trade names Bactrim, Septrin) is a drug that is given to children born to HIV-positive mothers to help prevent infection. Studies have shown that TMP-SMX also may kill malaria infection in the very early stages of infection in the body, which may positively impact the way the body can fight malaria infection. Researchers want to know if giving TMP-SMX for 6 months longer than usual helps children fight malaria better in this way.

Objective:

\- To find out if taking TMP-SMX for longer than usual helps fight off malaria in infants.

Eligibility:

\- Infants 0-6 weeks of age who are HIV negative.

Design:

* Infants will be screened with a medical history and physical exam. A small amount of blood will be taken. The mothers medical records will be reviewed. Mothers will be asked about when they breastfeed.
* Participants will take TMP-SMX according to their doctor s orders. In Uganda, mothers will get a mosquito net with insecticide on it as per standard of care.
* Participants will come to the clinic once a month, every month, until the study ends in 2 3 years. Each visit will repeat the screening visit.
* Participants will also visit the clinic every month for a medical history, physical exam, and different blood tests.
* Six weeks after breastfeeding is stopped, children taking TMP-SMX will come into the clinic and will either be taken off the drug or will continue taking the drug for 6 more months.
* If a child becomes sick, it is important that the mother bring him or her to the RHSP clinic in Rakai.

Conditions

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Steven J Reynolds, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
2 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-07
Primary Completion
2015-12-28
Completion
2016-12-14

Countries

  • Uganda

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 NCT02094508 on ClinicalTrials.gov