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.: PACTR201409000782309 Date of Approval: 05/03/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Randomized open-label trial to evaluate the efficacy of artesunate-amodiaquin for seasonal malaria chemoprevention in suburban school of Bamako, Sirak
Official scientific title Randomized open-label trial to evaluate the efficacy of artesunate-amodiaquin for seasonal malaria chemoprevention in suburban school of Bamako, Sirakoro-Meguetana, Mali
Brief summary describing the background and objectives of the trial This is a randomized open-label study with AS-AQ for seasonal malaria chemoprevention, conduct in the basic school of Sirakoro-Meguetana. The purpose of the study is to evaluate the efficacy of AS-AQ administered for seasonal malaria chemoprevention (SMC) in children aged 6 to 15 years in suburban school. The study will last 6 months. We also aim to assess the feasibility and safety of the administration of AS-AQ for SMC in school. Two hundred (200) pupils will be enrolled in this study and the enrollment is planned for 4 days. Children will be allocated into two arms of 100, one arm will receive AS-AQ and the other arm will be followed and receive care as recommended by the National Program of Malaria Control (prompt diagnosis and adequate treatment care using CTAs). The duration of AS-AQ administration is three days (D0, D1, D2) during four consecutive months
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 15/09/2013
Actual trial start date 23/10/2013
Anticipated date of last follow up 15/02/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
No 2013/76/CE/FMOS
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a randomisation table created by a computer software program The computer generated sequence was used, the allocation was done based on the participant arrival sequence in the clinic, the first participant receive the first allocation, the code used for two arms was : 0 =No AS-AQ ; 1= AS-AQ, Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Malaria episodes management Active and passive follow up Six months Malaria episodes management according to WHO guidelines (diagnosis and treatment with ACTs) 100 Historical
Experimental Group Artesunate-Amodiaquin once daily 3 days suing four months Administration of AS-AQ pe oS 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children aged 6-15 years; - Enrolled in basic school Sirakoro Meguètana; - Available and able to follow-up study visits; - Do not show any general danger signs (inability to drink, uncontrollable vomiting, history of convulsion, lethargy, inability to sit unaided) or other signs of severe and complicated malaria falciparum according to the criteria of WHO; - Obtaining informed consent from child parents or guardian; - No history of hypersensitivity reactions to study drugs reported ; - Presence of biological abnormalities identified at enrollment - Presence of any acute illness - Presence of chronic diseases (diabetes, High blood pressure etc.). - Presence of an evident pregnancy or revealed by a biological test - History of antimalarial treatment (ACTs or other) within 15 days before enrollment 6 Year(s) 15 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 31/07/2013 Ethic Committee of Faculty of Medecine and Dentistry
Ethics Committee Address
Street address City Postal code Country
Point G Bamako 1805 Mali
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Malaria incidence defined by the number of epidoses of uncomplicated malaria in the group receiving SMC compared to the control group During the study
Secondary Outcome 1. Incidence of anemia defined by the proportion of children with a Hb level <10g/dl in both groups 2. Safety : measured by the proportion of children who had an AE or SAE 3. Acceptability of the approach as measured by a questionnaire sent to teachers and students asking their views on the disadvantages, advantages, and their adherence to the approach. 4. School success/completion rates During the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MRTC/DEAP/FMOS/USTTB Point G Bamako 1805 Mali
FUNDING SOURCES
Name of source Street address City Postal code Country
National Center of Scientific Research Ngolonina Niaréla, Bamako 3052 Mali
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Malaria Research and Training Center/Faculty of Medecine and Dentistry/University of Sceinces, Techniques and Technologies Point G Bamako 1805 Mali Commercial Sector/Industry
Primary Sponsor Malaria Research and Training Center/Faculty of Medecine and Dentistry/University of Sceinces, Techniques and Technologies Point G Bamako 1805 Mali University
COLLABORATORS
Name Street address City Postal code Country
Elizabeth Diarra MRTC/DEAP/FMOS/USTTB Bamako 1805 Mali
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahamadou Ali Thera mthera@icermali.org (223) 66744061 Point G
City Postal code Country Position/Affiliation
Bamako 1805 Mali Professor of Parasitology-Mycology at Faculty of Medecine and Dentistry
Role Name Email Phone Street address
Public Enquiries Ogobara Doumbo okd@icermali.org (223) 20 22 81 09 Point G
City Postal code Country Position/Affiliation
Bamako 1805 Mali Director/MRTC/DEAP/FMOS/USTTB
Role Name Email Phone Street address
Scientific Enquiries Mahamadou Ali Thera mthera@icermali.org (223) 66744061 Point G
City Postal code Country Position/Affiliation
Bamako 1805 Mali Professor of Parasitology-Mycology at Faculty of Medecine and Dentistry
REPORTING
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