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 range0 Years – 5 Years

SexALL

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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

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