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: pactr.samrc.ac.za
Trial no.: PACTR201202000278282 Date of Approval: 16/02/2011
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
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 Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Other
Anticipated trial start date 13/12/2010
Actual trial start date 13/12/2010
Anticipated date of last follow up 31/12/2012
Actual Last follow-up date 01/10/2013
Anticipated target sample size (number of participants) 940
Actual target sample size (number of participants) 945
Recruitment status Completed
Publication URL http://www.ncbi.nlm.nih.gov/pubmed/27430374
Secondary Ids Issuing authority/Trial register
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-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum 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 Month(s) 5 Year(s) 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 07/07/2010 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 16/11/2010 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 12/07/2010 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 15/05/2012 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
Ifakara Health Institute PO Box 74 Bagamoyo Tanzania
CNRFP Balonghin, Burkina Faso Burkina Faso
NIMR PO Box 96 Kilosa Tanzania
KEMRI Kisumu Kenya
NIMR PO Box 210 Korogwe 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 Charities/Societies/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 Street address
Principal Investigator Sodiomon Bienvenu SIRIMA s.sirima.cnlp@fasonet.bf + 226 50 32 46 95 CNRFP, 01 BP2208
City Postal code Country Position/Affiliation
Ouagadougou Burkina Faso Physician
Role Name Email Phone Street address
Principal Investigator Bernhards OGUTU bogutu@wrp-ksm.org +254 20 2733031 Ngumo Estate, Off Mbagathi Road
City Postal code Country Position/Affiliation
Nairobi Kenya Physician
Role Name Email Phone Street address
Principal Investigator Zakayo MRANGO mrango@yahoo.com +255 22 2121400 NIMR, Kalenga Street
City Postal code Country Position/Affiliation
Dar Es Salaam Tanzania
Role Name Email Phone Street address
Principal Investigator Zakayo MRANGO mrango@yahoo.com +255 22 2121400 NIMR, Kalenga Street
City Postal code Country Position/Affiliation
Dar Es Salaam Tanzania Physician
Role Name Email Phone Street address
Principal Investigator John LUSINGU jpalusingu@gmail.com +255272644423 NIMR
City Postal code Country Position/Affiliation
Korogwe Tanzania Physician
Role Name Email Phone Street address
Principal Investigator Ali MTORO alimtoro@yahoo.com +255659933326 Ifakara Health Institute
City Postal code Country Position/Affiliation
Bagamoyo Tanzania Physician
Role Name Email Phone Street address
Public Enquiries Gwenaelle CARN gcarn@dndi.org +41 22 906 92 30 15 Chemin Louis Dunant
City Postal code Country Position/Affiliation
Geneva 1202 Switzerland Clinical Project Coordinator
Role Name Email Phone Street address
Scientific Enquiries Nathalie Strub nstrub@dndi.org +41 22 906 92 30 15 Chemin Louis Dunant
City Postal code Country Position/Affiliation
Geneva 1202 Switzerland Medical Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information