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

Sponsor

Université Victor Segalen Bordeaux 2 (Other)

Overall Status

Suspended

CT.gov ID

NCT00442403

Collaborator

(none)

200

Enrollment

Location

Duration (Months)

39.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malaria	Drug: chloroquine Drug: dehydroepiandrosterone sulphate	Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2002

Study Completion Date :

Sep 1, 2002

Outcome Measures

Primary Outcome Measures

Development of any adverse event; []
Rate of clinical and/or parasitological failure during the 14 days of follow up. []

Secondary Outcome Measures

Proportion of patients with positive blood smear during follow-u; []
Mean parasitemia during follow-up; []
Proportion of patients with clinical symptoms on day 3. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Medical Research and study of Medicinal Plants, Medical Research Center	Yaounde		Cameroon

Sponsors and Collaborators

Université Victor Segalen Bordeaux 2

Investigators

Study Director: Michel LE BRAS, Professor, Université Victor Segalen Bordeaux 2, Centre René Labusquière (Santé et Développement)
Principal Investigator: Pascal MILLET, Doctor, Université Victor Segalen Bordeaux 2, Pôle des Maladies Tropicale, CHU de Bordeaux