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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00442403
Recruitment Status : Suspended (At the end of the year 2002, Cameroon switched from chloroquine to amodiaquine as first-line therapy for of uncomplicated malaria.)
First Posted : March 1, 2007
Last Update Posted : March 1, 2007
Information provided by:
Université Victor Segalen Bordeaux 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
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 : April 2002
Study Completion Date : September 2002

Primary Outcome Measures :
  1. Development of any adverse event;
  2. Rate of clinical and/or parasitological failure during the 14 days of follow up.

Secondary Outcome Measures :
  1. Proportion of patients with positive blood smear during follow-u;
  2. Mean parasitemia during follow-up;
  3. Proportion of patients with clinical symptoms on day 3.

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00442403

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Institute of Medical Research and study of Medicinal Plants, Medical Research Center
Yaounde, Cameroon
Sponsors and Collaborators
Université Victor Segalen Bordeaux 2
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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

Layout table for additonal information Identifier: NCT00442403    
Other Study ID Numbers: FSP 97008500
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: March 1, 2007
Last Verified: February 2007
Keywords provided by Université Victor Segalen Bordeaux 2:
Plasmodium falciparum
Dehydroepiandrosterone sulphate
Additional relevant MeSH terms:
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Protozoan Infections
Parasitic Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antirheumatic Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors