SuspendedPhase 3

Safety and Efficacy of Chloroquine Associated With Dehydroepiandrosterone Sulphate to Treat Uncomplicated Falciparum Malaria

Stopped: At the end of the year 2002, Cameroon switched from chloroquine to amodiaquine as first-line therapy for of uncomplicated malaria.

Cameroon200 participantsStarted 2002-04

Plain-language summary

This study aims to evaluate the safety and efficacy of a standard chloroquine drug regimen administration supplemented with dehydroepiandrosterone sulfate against drug-resistant malaria.

Who can participate

Age range15 Years

SexALL

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: * signing an informed consent (informed consent was given by legal guardian for children); * age egal or more than 15 years; * fever (axillary temperature egal or more than 37.5 °C and less than 40°C) or a history of fever within the last 24 hours; * no sign suggestive of other febrile illness; * absence of signs of complicated malaria (WHO criteria); * willingness to participate in follow-up for 14 days * a positive thick blood film for P. falciparum without other detectable infectious microorganisms Exclusion Criteria: * patients taking glucocorticoids or other immuno-suppressive drugs, or indicating recent antimalarial drug history (verbal questionnaire); * severe malaria; * mixed infections; * women using contraceptives; * pregnant women; * breast-feeding women.

What they're measuring

Development of any adverse event;

Rate of clinical and/or parasitological failure during the 14 days of follow up.

Trial details

NCT IDNCT00442403

SponsorUniversité Victor Segalen Bordeaux 2

Sponsor typeOTHER

Study typeINTERVENTIONAL

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