Overview

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

Status:
Suspended
Trial end date:
2002-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Université Victor Segalen Bordeaux 2
Treatments:
Chloroquine
Chloroquine diphosphate
Dehydroepiandrosterone
Criteria
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.