search
Back to results

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

Primary Purpose

Malaria

Status
Suspended
Phase
Phase 3
Locations
Cameroon
Study Type
Interventional
Intervention
chloroquine
dehydroepiandrosterone sulphate
Sponsored by
Université Victor Segalen Bordeaux 2
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria focused on measuring Malaria, Plasmodium falciparum, Chemotherapy, Chloroquine, Dehydroepiandrosterone sulphate

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institute of Medical Research and study of Medicinal Plants, Medical Research Center

Outcomes

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.

Full Information

First Posted
February 28, 2007
Last Updated
February 28, 2007
Sponsor
Université Victor Segalen Bordeaux 2
search

1. Study Identification

Unique Protocol Identification Number
NCT00442403
Brief Title
Safety and Efficacy of Chloroquine Associated With Dehydroepiandrosterone Sulphate to Treat Uncomplicated Falciparum Malaria
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 Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Suspended
Why Stopped
At the end of the year 2002, Cameroon switched from chloroquine to amodiaquine as first-line therapy for of uncomplicated malaria.
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Université Victor Segalen Bordeaux 2

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Malaria, Plasmodium falciparum, Chemotherapy, Chloroquine, Dehydroepiandrosterone sulphate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
chloroquine
Intervention Type
Drug
Intervention Name(s)
dehydroepiandrosterone sulphate
Primary Outcome Measure Information:
Title
Development of any adverse event;
Title
Rate of clinical and/or parasitological failure during the 14 days of follow up.
Secondary Outcome Measure Information:
Title
Proportion of patients with positive blood smear during follow-u;
Title
Mean parasitemia during follow-up;
Title
Proportion of patients with clinical symptoms on day 3.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel LE BRAS, Professor
Organizational Affiliation
Université Victor Segalen Bordeaux 2, Centre René Labusquière (Santé et Développement)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pascal MILLET, Doctor
Organizational Affiliation
Université Victor Segalen Bordeaux 2, Pôle des Maladies Tropicale, CHU de Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Medical Research and study of Medicinal Plants, Medical Research Center
City
Yaounde
Country
Cameroon

12. IPD Sharing Statement

Citations:
PubMed Identifier
16846568
Citation
Libonati RM, de Mendonca BB, Maues JA, Quaresma JA, de Souza JM. Some aspects of the behavior of the hypothalamus-pituitary-adrenal axis in patients with uncomplicated Plasmodium falciparum malaria: Cortisol and dehydroepiandrosterone levels. Acta Trop. 2006 Jul;98(3):270-6. doi: 10.1016/j.actatropica.2006.05.008. Epub 2006 Jul 17.
Results Reference
background
PubMed Identifier
16699290
Citation
Libonati RM, Cunha MG, Souza JM, Santos MV, Oliveira SG, Daniel-Ribeiro CT, Carvalho LJ, do Nascimento JL. Estradiol, but not dehydroepiandrosterone, decreases parasitemia and increases the incidence of cerebral malaria and the mortality in plasmodium berghei ANKA-infected CBA mice. Neuroimmunomodulation. 2006;13(1):28-35. doi: 10.1159/000093271. Epub 2006 May 12.
Results Reference
background
PubMed Identifier
15476661
Citation
Safeukui I, Mangou F, Malvy D, Vincendeau P, Mossalayi D, Haumont G, Vatan R, Olliaro P, Millet P. Plasmodium berghei: dehydroepiandrosterone sulfate reverses chloroquino-resistance in experimental malaria infection; correlation with glucose 6-phosphate dehydrogenase and glutathione synthesis pathway. Biochem Pharmacol. 2004 Nov 15;68(10):1903-10. doi: 10.1016/j.bcp.2004.05.049.
Results Reference
background
PubMed Identifier
12854087
Citation
Leenstra T, ter Kuile FO, Kariuki SK, Nixon CP, Oloo AJ, Kager PA, Kurtis JD. Dehydroepiandrosterone sulfate levels associated with decreased malaria parasite density and increased hemoglobin concentration in pubertal girls from western Kenya. J Infect Dis. 2003 Jul 15;188(2):297-304. doi: 10.1086/376508. Epub 2003 Jul 1.
Results Reference
background
PubMed Identifier
12234842
Citation
Ayi K, Giribaldi G, Skorokhod A, Schwarzer E, Prendergast PT, Arese P. 16alpha-bromoepiandrosterone, an antimalarial analogue of the hormone dehydroepiandrosterone, enhances phagocytosis of ring stage parasitized erythrocytes: a novel mechanism for antimalarial activity. Antimicrob Agents Chemother. 2002 Oct;46(10):3180-4. doi: 10.1128/AAC.46.10.3180-3184.2002.
Results Reference
background
PubMed Identifier
11119497
Citation
Kurtis JD, Mtalib R, Onyango FK, Duffy PE. Human resistance to Plasmodium falciparum increases during puberty and is predicted by dehydroepiandrosterone sulfate levels. Infect Immun. 2001 Jan;69(1):123-8. doi: 10.1128/IAI.69.1.123-128.2001.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs