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.: PACTR202007754558749 Date of Approval: 31/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Randomized double-blinded controlled clinical trial to assess the efficacy of Dihydroartemisinin-Piperaquine compared to Sulfadoxine-Pyrimethamine associated to Amodiaquine in Seasonal Malaria Chemoprevention in school aged children from 6-15 years in Bandiagara, Mali
Official scientific title RCB-DHAPQ-SMC Randomized double-blinded controlled clinical trial to assess the efficacy of Dihydroartemisinin-Piperaquine compared to Sulfadoxine-Pyrimethamine associated to Amodiaquine in Seasonal Malaria Chemoprevention in school aged children from 6-15 years in Mali
Brief summary describing the background and objectives of the trial Seasonal Malaria Chemoprophylaxis with Sulfadoxine-Pyrimethamine associated to Amodiaquine (SP-AQ) is a malaria control strategy that targets children aged 3-59 months in areas where 60% or more of malaria transmission and disease burden occur in the rainy season over a period of about 4 months. School-aged children are not currently targeted by SMC in all countries and constitute a neglected population afflicted by seasonal malaria in countries where SMC is implemented. Modelling studies indicates that scale up of malaria interventions with high impact on disease burden may lead to an age shift in malaria burden. Evidence from field trials indicates that extending the age range for SMC may lead to reduced transmission of malaria and could contribute to programs to eliminate malaria transmission. SP-AQ is the currently recommended regimen for SMC and SP is also used in intermittent preventive treatment (IPT) in pregnant women. Pyrimethamine is known to rapidly select DHFR gene mutations associated with drug resistance to SP, therefore, SP is threatened by the rise and spread of drug resistant parasites. Hence, there is a need to have alternative drug regimens for SMC. Dihydroartemisinin-Piperaquine (DHA-PQ) is a long acting artemisinin-based combination therapy that is recommended by WHO for first line cure of uncomplicated malaria. The aim of this study is to establish the efficacy, effectiveness and safety of a preventive intervention with DHA-PQ to reduce malaria burden in school-aged children.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCB DHA PQ SMC
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 01/09/2020
Actual trial start date 12/09/2020
Anticipated date of last follow up 31/08/2021
Actual Last follow-up date 21/09/2021
Anticipated target sample size (number of participants) 345
Actual target sample size (number of participants) 345
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group DHA PQ plus Albendazol DHA-PQ: 4mg/kgbw for DHA and 18mg/kgbw for piperaquine once a day for three days Albendazole is given at one tablet of 400mg per day for three days 4 months, 3 consecutive days of treatment per month DHA-PQ, given four consecutive months for three days, at a 4mg/kgbw for DHA and 18mg/kgbw for piperaquine once a day for three days Albendazole is given at one tablet of 400mg per day for three days 115
Experimental Group SP AQ plus Albendazole SP: 25mg/kgbw of Sulfadoxine plus 1.25mg/kgbw of Pyrimethamine, single dose AQ: 10 mg/kgbw Albendazole is given at one tablet of 400mg per day for three days Fours consecutives months, 3 days per month SP-AQ will given during three days Day 1, SP given at 25mg/kgbw of Sulfadoxine plus 1.25mg/kgbw of Pyrimethamine; associated to 10 mg/kgbw of AQ; Days 2 and 3: AQ will be given at the dose of 10mk/kgbw. Albendazole is given at one tablet of 400mg per day for three days 115
Control Group Albendazole 400 mg Once a day for 3 consecutive days per month, for 4 months Control group will be given one tablet of albendazole 400 mg once a day, during 3 consecutive days, the same timing with the SMC groups 115 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children aged 6 to 15 enrolled in the Bandiagara Basic School; Available and able to make follow-up visits; Do not show any general signs of danger or other signs of severe and complicated P. falciparum malaria according to the WHO criteria; Informed consent of the parents or guardian of the child and children assent (13-15 years old) obtained. No abnormalities in EKG No known history of hypersensitivity reaction to the drugs used. Children who do not meet all the inclusion criteria Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 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 16/07/2020 Comite Ethique FMOS FAPH
Ethics Committee Address
Street address City Postal code Country
Faculte de medecine et odontostomatologie Faculte de Pharmacie Bamako 1805 Mali
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The incidence of clinical malaria in school aged children, defined as presence of asexual forms of P. falciparum in peripheral blood determined by thick smear associated with symptoms described by WHO and without signs of danger or severe illness During follow-up, unscheduled visits, months 6 and 12
Secondary Outcome Prevalence of P. falciparum gametocyte in school aged-children at cross sectional surveys Months 6 and 12
Secondary Outcome Prevalence of malaria infection in school aged-children at cross sectional surveys Months 6 and 12
Secondary Outcome Prevalence of adverse events in DHA-PQ group, compared to SP-AQ group and control group days 1, 2, 3, 7 post treatment
Secondary Outcome Prevalence of molecular markers of resistance to SP, AQ, DHA-PQ after SMC At inclusion, months 6 and 12
Secondary Outcome Incidence of all causes of morbidity in school aged children Trough the study during follow-up
Primary Outcome School performance of children Month 12
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bandiagara Malaria Project Bandiagara Bandiagara Mali
FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trials Partnership EDCTP Anna Van Saksenlaan 51, 2593 HW The Hague 93015 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Universite des Sciences des Techniques et des Technologies de Bamako USTTB Hamdallaye ACI 2000 - Rue 405 - Porte 359 Bamako 2528 Mali University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Karim Traore karim@icermali.org +22320228109 MRTC-DEAP-FMOS, Point G
City Postal code Country Position/Affiliation
Bamako 1805 Mali EDCTP Senior Fellow
Role Name Email Phone Street address
Scientific Enquiries Mahamadou A. Thera mthera@icermali.org +22320228109 MRTC-DEAP-FMOS, Point G
City Postal code Country Position/Affiliation
Bamako 1805 Mali Scientific Director
Role Name Email Phone Street address
Public Enquiries Drissa Coulibaly coulibalyd@icermali.org +22320228109 MRTC-DEAP-FMOS, Point G
City Postal code Country Position/Affiliation
Bamako 1805 Mali Clinical coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Additional documents (study protocol, informed consent and clinical study report) will be available and open. Data base will be available on request Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Study protocol and informed consent will be available before the study starts, progress reports will be submitted after the fourth round of SMC, a final report will be submitted 3 months after the last subject last visit. Data base will be available and controlled after the data base lock. Data base access will be controlled, available on request to the PI All the other additional documents will be open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 30/04/2024 08/09/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 30/04/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information