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

Etude de l'Activite (Efficacite et Tolerance) de l'Association de la Chloroquine Avec la Dehydroepiandrosterone-Sulfate (Dheas) Dans le Traitement de l'Acces Palustre Simple A Plasmodium Falciparum

Status

Suspended

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00442403

Enrollment

200

Registered

2007-03-01

Start date

2002-04-30

Completion date

2002-09-30

Last updated

2007-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Keywords

Malaria, Plasmodium falciparum, Chemotherapy, Chloroquine, Dehydroepiandrosterone sulphate

Brief 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.

Detailed description

Worldwide progression of Plasmodium falciparum chloroquine (CQ), amodiaquine and sulfadoxine-pyrimethamine resistance leaves few alternative for the control of malaria, particularly in Africa. For some strains of P. falciparum and P. berghei, the resistance to CQ and AQ is linked to an increase in reduced glutathione (GSH) levels and GSH-related enzyme activity, such as glucose 6-phosphate deshydrogenase (G6PD). The pro-hormone dehydroepiandrosterone sulphate can be used to potentiate the antimalarial action of CQ on drug resistant P. falciparum strains, by inhibiting parasite G6PD activity. This hormone has a second advantage: it is metabolised in human into a series of potent immunomodulatory steroids which may be in the causal pathway that allowed the induction of protective immune responses against several infections, included malaria. This first study evaluated the tolerance and efficacy of a standard CQ regimen supplemented with dehydroepiandrosterone sulphate for the treatment of drug resistant uncomplicated falciparum malaria.

Interventions

DRUGchloroquine

DRUGdehydroepiandrosterone sulphate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Development of any adverse event;	—
Rate of clinical and/or parasitological failure during the 14 days of follow up.	—

Secondary

Measure	Time frame
Proportion of patients with positive blood smear during follow-u;	—
Mean parasitemia during follow-up;	—
Proportion of patients with clinical symptoms on day 3.	—

Countries

Cameroon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026