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

NCT00442403 | Suspended Phase 3

• 1 other identifier: FSP 97008500
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

Malaria; Plasmodium falciparum; Chemotherapy; Chloroquine; Dehydroepiandrosterone sulphate

Outcome Measures

Primary Outcomes (2)

• Development of any adverse event;

• Rate of clinical and/or parasitological failure during the 14 days of follow up.

Secondary Outcomes (3)

• Proportion of patients with positive blood smear during follow-u;

• Mean parasitemia during follow-up;

• Proportion of patients with clinical symptoms on day 3.

Interventions

chloroquine DRUG

dehydroepiandrosterone sulphate DRUG

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université Victor Segalen Bordeaux 2: lead

Study Sites (1)

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

Yaoundé, Cameroon

Location

Related Publications (6)

• 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.

  PMID: 16846568 BACKGROUND

• 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.

  PMID: 16699290 BACKGROUND

• 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.

  PMID: 15476661 BACKGROUND

• 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.

  PMID: 12854087 BACKGROUND

• 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.

  PMID: 12234842 BACKGROUND

• 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.

  PMID: 11119497 BACKGROUND

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Interventions

Chloroquine; Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Michel LE BRAS, Professor

  Université Victor Segalen Bordeaux 2, Centre René Labusquière (Santé et Développement)

  STUDY DIRECTOR

• Pascal MILLET, Doctor

  Université Victor Segalen Bordeaux 2, Pôle des Maladies Tropicale, CHU de Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 28, 2007
• First Posted: March 1, 2007
• Study Start: April 1, 2002
• Study Completion: September 1, 2002
• Last Updated: March 1, 2007

Record last verified: 2007-02

Locations

CA (1)