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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201202000278282 Date registered: 2011/02/16
TRIAL DESCRIPTION
Public title Efficacy, Safety and Population-Pharmacokinetics of Artesunate-Mefloquine combination for the Treatment of Uncomplicated Falciparum Malaria in African
Official scientific title Efficacy, Safety and Population-Pharmacokinetics of Artesunate-Mefloquine combination for the Treatment of Uncomplicated Falciparum Malaria in African children versus Artemether-Lumefantrine
Brief summary describing the background
and objectives of the trial
The combination of AS and MQ, whether in loose or fixed combination, was the first of the ACTs, used extensively in Asia and Latin America, however there is very limited data on its efficacy and safety in young children in Africa. The objective of this clinical study is to evaluate efficacy, safety and population-pharmacokinetics of a new fixed-dosed combination of Artesunate-Mefloquine, for the treatment of under-5 children with uncomplicated P. falciparum malaria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DNDi-ASMQ-AF09
Disease(s) or condition(s) being studied Malaria ,
Purpose of the trial Treatment
Anticipated trial start date 2010-12-13
Actual trial start date 2010-12-13
Anticipated date of last follow up 2012-12-31
Actual date of last follow up 2013-10-01
Anticipated target sample size (number of participants) 940   
Actual target sample size (number of participants)   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID
ISRCTN17472707 ISRCTN

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
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 Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group ASMQ 6 -11 months: 1 tablet /day;1-5 y: 2 tablets /day 3 days ASMQ administered orally once a day 470
Control group Coartem® dispersible 5-<15 kg BW: 2 tablets/day; 15-<25 kg BW: 4 tablets/day 3 days Coartem® dispersible administered orally twice a day 470 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
1. Age between 6 to 59 months. 2. Presence of acute uncomplicated P. falciparum mono-infection confirmed by: a. Axillary temperature >37.5°C and, b. Positive microscopy of P. falciparum with parasite density between 2,000 and 200,000 asexual parasites/µl 3. Written informed consent from parent/guardian 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. 6 Months 5 Years Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2010/07/07 Comité d'éthique pour la Recherche en Santé
Ethics Committee Address
Street address City Postal code Country
Ouagadougou Burkina Faso
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2010/11/16 KEMRI/National Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
PO Box 54840 Nairobi 00200 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2010/07/12 Ministry of Health and Social Welfare
Ethics Committee Address
Street address City Postal code Country
Dar Es Salaam PO Box 9083 Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2012/05/15 Ministry of Health and Social Welfare
Ethics Committee Address
Street address City Postal code Country
Dar Es Salaam PO Box 9083 Tanzania

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cure rate as determined by PCR-corrected adequate clinical and parasitological response (ACPR) Day 63.
Secondary Outcome Safety : frequency of Adverse Events and Serious Adverse Events Treatment Period (first 3 days) Day 7 Day 14 Day 21 Day 28 Day 35 Day 42 Day 49 Day 56 Day 63
Secondary Outcome Cure rate Day 28 Day 42
Secondary Outcome Population pharmacokinetic parameters for artesunate (AS), its main metabolite, dihydroartemisinin (DHA), mefloquine (MQ) and Lumefantrine Day 0, Day 2, Day 3, Day 7, 1 sample randomly selected times in day 28, 35, 42, 49, 56 or 63 Last visit

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CNRFP Balonghin, Burkina Faso Burkina Faso
NIMR PO Box 96 Kilosa Tanzania
KEMRI Kisumu Kenya
NIMR PO Box 210 Korogwe Tanzania
Ifakara Health Institute PO Box 74 Bagamoyo Tanzania

FUNDING SOURCES
Name of source Street address City Postal code Country
DNDi 15 chemin Louis Dunant Geneva 1202 Switzerland
DGIS Ministry of Foreign Affairs Postbus 20061 Den Haag 2500 Netherlands
DFID Eaglesham Road Glasgow United Kingdom
EDCTP 334 Laan van Nieuw Oost Indië The Hague P.O.Box 93015 Netherlands
Agence Française de Développement (AFD) 5 rue Roland Barthes PARIS Cedex 12 75598 France

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DNDi 15 chemin Louis Dunant Geneva 1202 Switzerland Foundation

COLLABORATORS
Name Street address City Postal code Country
Dr SIRIMA CNRFP Ouagadougou 2208 Burkina Faso
Dr OGUTU KEMRI, Ngumo Estate, Off Mbagathi Road Nairobi 00202 Kenya
Dr MRANGO Kalenga Street Dar Es Salaam PO Box 3436 Tanzania
Dr LUSINGU NIMR Korogwe PO Box 210 Tanzania
Dr Mtoro Ifakara Health Institute Bagamoyo PO Box 74 Tanzania

CONTACT PEOPLE
Role Name Email Phone Fax
Public Enquiries Ms Gwenaelle CARN gcarn@dndi.org +41 22 906 92 30 +41 22 906 92 31
Street address City Postal code Country Position / Affiliation
15 Chemin Louis Dunant Geneva 1202 Switzerland Clinical Project Coordinator
Role Name Email Phone Fax
Scientific Enquiries Dr Nathalie Strub nstrub@dndi.org +41 22 906 92 30 +41 22 906 92 31
Street address City Postal code Country Position / Affiliation
15 Chemin Louis Dunant Geneva 1202 Switzerland Medical Director
Role Name Email Phone Fax
Principal Investigator Dr Sodiomon Bienvenu SIRIMA s.sirima.cnlp@fasonet.bf + 226 50 32 46 95
Street address City Postal code Country Position / Affiliation
CNRFP, 01 BP2208 Ouagadougou Burkina Faso Physician
Role Name Email Phone Fax
Principal Investigator Dr Bernhards OGUTU bogutu@wrp-ksm.org +254 20 2733031
Street address City Postal code Country Position / Affiliation
Ngumo Estate, Off Mbagathi Road Nairobi Kenya Physician
Role Name Email Phone Fax
Principal Investigator Dr Zakayo MRANGO mrango@yahoo.com +255 22 2121400
Street address City Postal code Country Position / Affiliation
NIMR, Kalenga Street Dar Es Salaam Tanzania
Role Name Email Phone Fax
Principal Investigator Dr Zakayo MRANGO mrango@yahoo.com +255 22 2121400
Street address City Postal code Country Position / Affiliation
NIMR, Kalenga Street Dar Es Salaam Tanzania Physician
Role Name Email Phone Fax
Principal Investigator Dr John LUSINGU jpalusingu@gmail.com +255272644423
Street address City Postal code Country Position / Affiliation
NIMR Korogwe Tanzania Physician
Role Name Email Phone Fax
Principal Investigator Mr Ali MTORO alimtoro@yahoo.com +255659933326
Street address City Postal code Country Position / Affiliation
Ifakara Health Institute Bagamoyo Tanzania Physician