CompletedNot Applicable

TIPTOP Sulfadoxine-pyrimethamine (SP) Drug Resistance Study

Democratic Republic of the Congo, Madagascar, Mozambique7,200 participantsStarted 2018-03-05

Plain-language summary

The main objective of this study is to monitor SP resistance via molecular markers in the context of the TIPTOP project implementation of community distributed SP for women during pregnancy. The specific objective is to detect trends over time in the proportion of symptomatic children with a positive rapid diagnostic test (RDT) residing in the areas where C-IPTp is implemented who carry parasites with dhfr/dhps mutations compared to those in control areas with no community SP distribution.

Who can participate

Age range

0 Years – 5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * • Children under five years of age. * Being resident in the project area at the time of the survey. * Clinical signs and symptoms suggestive of malaria infection: fever (axillary temperature ≥37.5ºC) or history of fever in the preceding 24 hours. Exclusion Criteria: * Not willing to provide informed consent * Signs or symptoms of severe malaria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

change in prevalence of molecular markers associated with SP resistance at 36 months

Timeframe: baseline to endline (approximately 36 months later)

change in prevalence of molecular markers associated with SP resistance at 18 months

Timeframe: baseline to midline (approximately 18 months later)

Trial details

NCT IDNCT03998839

SponsorJhpiego

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-11-30

View on ClinicalTrials.gov More Malaria in Pregnancy trials