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.: PACTR201409000702188 Date of Approval: 09/11/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Monitoring Artemether-Lumefantrin (ALU) and Artesunate-Amodiaquin (AS-AQ) efficacy in uncomplicated malaria treatment in Bandiagara, and Doneguebougou
Official scientific title Monitoring Artemether-Lumefantrin (ALU) and Artesunate-Amodiaquin (AS-AQ) efficacy in uncomplicated malaria treatment in Bandiagara, and Doneguebougou¿s area, Mali.
Brief summary describing the background and objectives of the trial The study design is a WHO vivo study to monitor efficacy of ACTs, eligible patients received either ALU or ASAQ for the treatment of uncomplicated malaria, the study take place in Bandiagara, and Doneguebougou. The study objective is to monitor the efficacy of AS-AQ and AL on P. falciparum malaria occurring in volunteers aged 6 months to 70 years. A total of 160 volunteers will be included in each arm and the enrollment will last 6 months. The Treatment follow up period is 42 days after the start of treatment, AS-AQ or ALU is given on Days 0, 1 and 2, a thick smear, hemoglobin level and filter paper blot will be performed on days 0, 1, 2, 3, 7, 14, 21, 28, 35 and 42.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Drugs
Anticipated trial start date 16/10/2012
Actual trial start date 16/10/2012
Anticipated date of last follow up 28/10/2013
Actual Last follow-up date 29/11/2013
Anticipated target sample size (number of participants) 320
Actual target sample size (number of participants) 320
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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 Non-randomised Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Artemether-Lumefantrin or Artesunate-Amodiaquin per range of Weigh 3 days Study participants with uncomplicated malaria receive ALU or AS-AQ folllow up for 42 days 160
Experimental Group Artemether-Lumefantrin or Artesunate-Amodiaquin per range of Weigh 3 days Study participants with uncomplicated malaria receive ALU or AS-AQ follow up for 42 days, volunteers were included in ALU group first, when this group was complet, recruitment was continued, patients with malaria were included in ASAQ group. We assume particpants have equal chance to participe in the order they have arrived at center, the two groups were not defined prior the study initiation 160
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- age between 6 months-70 years; - résident in Bandiagara and area of Donéguébougou during study follow up periode ; - Be able to take tablet per os - Body temperature ¿ 37,5 degree Celsius or history of fievre within last 24 hours; - Plasmodium falciparum infection parasitemia between 2000 et 200 000 asexual forms/ul associated or not with P. ovale, P. malaria and/or P. vivax ; - consent of participant or/and parent (ou guardian) for children Clinical signs of severe malaria or cerebral malaria according to WHO criteria - Patients with severe concomitant disease - Concomitant febrile disorders (otitis, Acute chest infection, tonsillitis and others) - Have a lower than 8 g / dl hemoglobin; - Known to be allergic to artemisinin derivatives; - Have a documented decision CTA in the last fifteen (15) days. 6 Year(s) 70 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 09/11/2012 Ethic committee of Faculty of Medicine, Pharmacy and Dentistry
Ethics Committee Address
Street address City Postal code Country
Facculty of Medecine and Dentistry, BP:1805 Point G Bamako Mali
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time to parasite clearance, Proportion of subjects with Clinical and Parasitological Response Adequate, Proportion of subjects with parasitaemia on day 3 Do, D1, D2: at each 12 hours thick smears are performed until negative microscopic examination, D3, D7, D14, D21, D28, D35, and D42: thick smear
Secondary Outcome Time to gametocytes clearance From Do to day of gametocytes disappearance
Secondary Outcome Time to fever clearance form D0 to days (D1, D2, D3) with temperature < 37.5
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Malaria Research and Training Center Doneguebougou 1805 Mali
Malaria Research an Training Center Bandiagara 1805 Mali
FUNDING SOURCES
Name of source Street address City Postal code Country
WANETAM/MRTC Malaria Research and Training Center, Department of Epidemiology of Parasitic Diseases/Faculty of Medecine and Dentistry/USTTB Bamako Mali
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor WANETAM/MRTC/DEAP/FMOS/USTTB MRTC/DEAP/Faculty of Medicine and Dentistry Bamako Mali Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Amadou Niangaly MRTC/DEAP Bamako Mali
Doumbo Safiatou Niare MRTC/DEAP/FMOS Bamako 1805 Mali
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdoulaye Kassoum Kone fankone@icermali.org 223 20 22 0981 MRTC/DEAP/FMOS/USTTB
City Postal code Country Position/Affiliation
Bamako Mali Assistant Professor
Role Name Email Phone Street address
Public Enquiries Doumbo Ogobara K. okd@icermali.org (223) 20 22 09 81
City Postal code Country Position/Affiliation
Bamako 1805 Mali Prof in Parasitology-Mycology, Director of MRTC/DEAP
Role Name Email Phone Street address
Scientific Enquiries Thera Mahamadou Ali mthera@icermali.org (223)20 22 09 81 MRTC/DEAP/FMOS
City Postal code Country Position/Affiliation
Bamako 1805 Mali Prof in Parasitology-Mycology, Faculty of medicine and dentistry
REPORTING
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