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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Malaria

Intervention / Treatment
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* Drug: chloroquine
* Drug: dehydroepiandrosterone sulphate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: chloroquine|nan|
|Drug: dehydroepiandrosterone sulphate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of any adverse event; |  |  | 
| Rate of clinical and/or parasitological failure during the 14 days of follow up. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malaria, Plasmodium falciparum, Chemotherapy, Chloroquine, Dehydroepiandrosterone sulphate