MalariaPhase 3NCT00442403
Safety and Efficacy of Chloroquine Associated With Dehydroepiandrosterone Sulphate to Treat Uncomplicated Falciparum Malaria
A Phase 3 study testing chloroquine and dehydroepiandrosterone sulphate in people with Malaria, run by Université Victor Segalen Bordeaux 2 at 1 site in Cameroon.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Malaria
- What is being tested?
- chloroquine and dehydroepiandrosterone sulphate
- How many people
- 200 participants
- Where
- 1 siteCameroon
- Study dates
- Apr 2002to Sep 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Cameroon1 site
Institute of Medical Research and study of Medicinal Plants, Medical Research Center
Yaoundé
About this study
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
This study aims to evaluate the safety and efficacy of a standard chloroquine drug regimen administration supplemented with dehydroepiandrosterone sulfate against drug-resistant malaria.
Read the 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.
- Conditions
- Malaria
- Being tested
- chloroquine, dehydroepiandrosterone sulphate
- Keywords
- Malaria, Plasmodium falciparum, Chemotherapy, Chloroquine, Dehydroepiandrosterone sulphate
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chloroquineDrug
dehydroepiandrosterone sulphateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startApr 2002
- Study completionSep 2002
Why it stopped: At the end of the year 2002, Cameroon switched from chloroquine to amodiaquine as first-line therapy for of uncomplicated malaria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Université Victor Segalen Bordeaux 2
- Sponsor type
- University, hospital or other
- Investigators
- Michel LE BRAS, Professor, Study director, Université Victor Segalen Bordeaux 2, Centre René Labusquière (Santé et Développement)Pascal MILLET, Doctor, Principal investigator, Université Victor Segalen Bordeaux 2, Pôle des Maladies Tropicale, CHU de Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442403
- Sponsor's protocol ID
- FSP 97008500
- Status last verified
- Feb 2007
- First submitted
- 28 Feb 2007
- Last updated
- 1 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16846568Libonati 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.
PubMed 16699290Safeukui 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.
PubMed 15476661Leenstra 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.
PubMed 12854087Ayi 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.
PubMed 12234842Kurtis 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.
PubMed 11119497
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00442403
- Acronym / sponsor ID
- FSP 97008500
- Conditions
- Malaria
- Keywords
- Malaria, Plasmodium falciparum, Chemotherapy, Chloroquine, Dehydroepiandrosterone sulphate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: At the end of the year 2002, Cameroon switched from chloroquine to amodiaquine as first-line therapy for of uncomplicated malaria.
- Enrolment
- 200 participants
- Lead sponsor
- Université Victor Segalen Bordeaux 2University, hospital or other
- Study start
- Apr 2002
- Study completion
- Sep 2002
- First posted
- 1 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chloroquine | Drug | – |
| dehydroepiandrosterone sulphate | Drug | – |
Primary outcome
Development of any adverse event;
Rate of clinical and/or parasitological failure during the 14 days of follow up.
3 secondary outcomes
Proportion of patients with positive blood smear during follow-u;
Mean parasitemia during follow-up;
Proportion of patients with clinical symptoms on day 3.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2007.
- Background: PubMed 16846568Libonati 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.
- Background: PubMed 16699290Libonati 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.
- Background: PubMed 15476661Safeukui 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.
- Background: PubMed 12854087Leenstra 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.
- Background: PubMed 12234842Ayi 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.
- Background: PubMed 11119497Kurtis 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.
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel LE BRAS, Professor study director
Université Victor Segalen Bordeaux 2, Centre René Labusquière (Santé et Développement)
Pascal MILLET, Doctor principal investigator
Université Victor Segalen Bordeaux 2, Pôle des Maladies Tropicale, CHU de Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing chloroquine and dehydroepiandrosterone sulphate in people with Malaria, run by Université Victor Segalen Bordeaux 2 at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of any adverse event;. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00442403, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2007.