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Report for Clinical Trial NCT00125489

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Chloroquine and Sulfadoxine-Pyrimethamine Efficacy for the Treatment of Uncomplicated Falciparum Malaria in Blantyre, Malawi

The purpose of this research study is to find out how well chloroquine works as a drug to treat malaria in children, compared to the standard malaria treatment in Malawi. In preparation for a longer study of the malaria treatment medication chloroquine alone and in combination with other drugs, a shorter pre-study will be done to compare the anti-malarial effectiveness of chloroquine versus sulfadoxine-pyrimethamine (SP), the standard treatment in Malawi. Two hundred ten children, ages 6 months to 12 years, around Blantyre, Malawi, will be given standard dosing of either chloroquine or SP when they come to the Ndirande Health Centre with signs or symptoms consistent with malaria. The first 30 participants in each treatment group will remain under continuous observation at the health center so that the researchers can monitor their response to the medication until the infection goes away. The participants will be followed for 28 days to see if the the treatment works or fails.

NCT00125489 Malaria Plasmodium Falciparum Malaria
MeSH: Malaria Malaria, Falciparum

2 Interventions

Name: chloroquine sulfate

Type: Drug

Name: sulfadoxine/pyrimethamine

Type: Drug



Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 K76T

The secondary study endpoints are: (1) rates of early and late therapeutic failure; (2) rates of early and late parasitologic failure; (3) prevalence of chloroquine-resistance conferring pfcrt K76T mutation in pre-treatment infections; (4) rates of pre- and post-treatment pfcrt K76T mutation in cases of chloroquine treatment failure; (5) prevalence of SP-resistance conferring dhfr/dhps mutations in pre-treatment infections; (6) rates of pre- and post-treatment dhfr/dhps mutations in cases of SP treatment failure; (7) clearance time of parasitemia; (8) clearance time of fever; and (9) presence of post-treatment anemia. --- K76T ---

The secondary study endpoints are: (1) rates of early and late therapeutic failure; (2) rates of early and late parasitologic failure; (3) prevalence of chloroquine-resistance conferring pfcrt K76T mutation in pre-treatment infections; (4) rates of pre- and post-treatment pfcrt K76T mutation in cases of chloroquine treatment failure; (5) prevalence of SP-resistance conferring dhfr/dhps mutations in pre-treatment infections; (6) rates of pre- and post-treatment dhfr/dhps mutations in cases of SP treatment failure; (7) clearance time of parasitemia; (8) clearance time of fever; and (9) presence of post-treatment anemia. --- K76T --- --- K76T ---



HPO Nodes