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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201202000278282 |
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Date of registration:
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16/02/2011 |
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Primary sponsor: |
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Public title:
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Efficacy, Safety and Population-Pharmacokinetics of Artesunate-Mefloquine combination for the Treatment of Uncomplicated Falciparum Malaria in African
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Scientific title:
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Efficacy, Safety and Population-Pharmacokinetics of Artesunate-Mefloquine combination for the Treatment of Uncomplicated Falciparum Malaria in African children versus Artemether-Lumefantrine |
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Date of first enrolment:
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2010-12-13 |
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Target sample size:
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940 |
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Recruitment status: |
Open to recruitment: actively recruiting participa |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201202000278282 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Randomised,
Randomisation using a randomisation table created by a computer software program,
Sealed opaque envelopes,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Gwenaelle
CARN |
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Address:
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15 Chemin Louis Dunant
1202
Geneva
Switzerland |
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Telephone:
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+41 22 906 92 30 |
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Email:
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gcarn@dndi.org |
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Affiliation:
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Clinical Project Coordinator |
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Name:
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Nathalie
Strub |
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Address:
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15 Chemin Louis Dunant
1202
Geneva
Switzerland |
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Telephone:
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+41 22 906 92 30 |
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Email:
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nstrub@dndi.org |
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Affiliation:
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Medical Director |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age between 6 to 59 months.
2. Presence of acute uncomplicated P. falciparum mono-infection confirmed by:
a. Axillary temperature b37.5?C and,
b. Positive microscopy of P. falciparum with parasite density between 2,000 and 200,000 asexual parasites/?l
3. Written informed consent from parent/guardian
Exclusion criteria: 1. Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organization Criteria 2000
2. Weight ` 5kg
3. Inability to tolerate oral medication (presence of any of the following danger signs: unable to drink or breastfeed, severe vomiting, recent history of convulsions, lethargic or unconscious state, unable to sit or stand up)
4. Mixed Plasmodium infection.
5. Presence of febrile conditions caused by diseases other than malaria.
6. Known history of hypersensitivity, allergic or serious adverse reactions to Mefloquine, Quinine, Quinidine, Artesunate or other Artemisinins.
7. History of use of any anti-malarial agent within 2 weeks prior to start of the study (except mefloquine and piperaquine within 4 weeks).
8. Prior participation to a therapeutic trial within 3 months.
Age minimum:
6 Month
Age maximum:
5 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Malaria
null
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Primary Outcome(s)
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Cure rate as determined by PCR-corrected adequate clinical and parasitological response (ACPR)
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Secondary Outcome(s)
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Cure rate
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Population pharmacokinetic parameters for artesunate (AS), its main metabolite, dihydroartemisinin (DHA), mefloquine (MQ) and Lumefantrine
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Safety : frequency of Adverse Events and Serious Adverse Events
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Secondary ID(s)
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ISRCTN17472707
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Source(s) of Monetary Support
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EDCTP
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DFID
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DGIS Ministry of Foreign Affairs
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DNDi
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