Clinical trial
Clinical Trial to Evaluate Efficacy and Safety of Sulfadoxine/Pyrimethamine-Amodiaquine and Dihydroartemsinin-Piperaquine Plus Ivermectin Administered Monthly as Intermittent Preventive Treatment in School-aged Children in Burkina Faso
Name
IPTsc-BF
Description
This will be an open label cluster randomized study with two active intervention and one control arm. A cluster will be defined as a selected village. One district implementing seasonal malaria chemoprevention (SMC) will be selected, and six villages will be randomly selected in this district. These six villages will be randomly allocated to each of the three study arms; 1) Arm 1 will receive IPTsc with sulphadoxine-pyrimethamine plus amodiaquine (SPAQ); and 2) Arm 2 will receive dihydroartemisinin-piperaquine (DP) plus Ivermectin (IVM), all given monthly during the transmission season and 3) Control Arm which will have standard malaria control measures including case management and vector control measures as applicable.
Trial arms
Trial start
2023-07-15
Estimated PCD
2024-05-31
Trial end
2024-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Sulphadoxine-Pyrimethamine/Amodiaquine
Co-blister packaging of sulfadoxine-pyrimethamine (SP) dispersible tablets administered on the first day and amodiaquine (AQ) dispersible tablets administered once daily for three days. The dose of SPAQ will be determined according to the child's age.
Arms:
Sulphadoxine-Pyrimethamine/Amodiaquine (SPAQ)
Other names:
SPAQ
Dihydroartemisinin/Piperaquine (DP) plus Ivermectin (IVM)
DP will consist of tablets containing 320/40 mg and 160/20 mg piperaquine/dihydroartemisinin per tablet. A full course of DP should be administered in accordance with the manufacturer's instructions, once a day for 3 days, according to body weight. DP should be taken orally with water and without food. It will be given in association with Ivermectin.
Ivermectin (IVM) will be available as 3 mg or 6 mg tablets to be administered at the doses of 300- 400μg/kg/day for 3 days (to the nearest whole tablet). IVM should also be taken with water on an empty stomach.
Arms:
Dihydroartemisinin/Piperaquine (DP) plus Ivermectin (IVM)
Other names:
DP plus IVM
Size
13000
Primary endpoint
Prevalence of symptomatic malaria in children of the target age group by microscopy and molecular methods.
6 months
Eligibility criteria
Inclusion Criteria:
* Resident in the study area and willing to remain there for the study duration
* Age \> or = 5 and \< 15 years
* Willing to provide biological samples as requested during the study period
* Provision of informed consent by parents/guardians
* Provision of assent from children aged 12 to 15 years.
Exclusion Criteria:
* Any serious illness or medical situation that could interfere with follow-up
* Inability to take study medication
* History of known allergy or contraindication to study drugs
* History of cardiac disorders or prolonged QT syndrome
* Current use of drugs known to prolong QT interval
* Participating in another research project.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 13000, 'type': 'ESTIMATED'}}
Updated at
2023-11-22
1 organization
Organization
Malaria Consortium