Innovative Intermittent Preventive Treatment Approaches to Reduce Malaria Burden in School-age Children in Burkina Faso
BF-IPTsc
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
1 other identifier
interventional
13,000
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2023
CompletedFirst Posted
Study publicly available on registry
July 14, 2023
CompletedStudy Start
First participant enrolled
July 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedNovember 22, 2023
July 1, 2023
11 months
June 27, 2023
November 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Prevalence of symptomatic malaria in children of the target age group by microscopy and molecular methods.
prevalence of clinical malaria in the different study arms
6 months
Secondary Outcomes (6)
Prevalence of asymptomatic malaria
6 months
Prevalence of anemia
6 months
Prevalence of gametocytes determined by microscopy.
6 months
Prevalence of antimalarial drug resistance markers
6 months
Acceptability of the two IPTsc approaches
6 months
- +1 more secondary outcomes
Study Arms (3)
Sulphadoxine-Pyrimethamine/Amodiaquine (SPAQ)
EXPERIMENTALSPAQ treatment will be given according to child's age. Dispersible tablets of sulphadoxine-pyrimethamine (SP) will be given on day 1 only. Dispersible tablets of amodiaquine (AQ) which will be given once a day for 3 days. The full 3-day course will be administered each month under directly observed therapy (DOT).
Dihydroartemisinin/Piperaquine (DP) plus Ivermectin (IVM)
EXPERIMENTALDP will be available as tablets of 320/40mg and 160/20mg piperaquine/dihydroartemisinin per tablet. DP will be given once daily for 3 days and according to body weight. IVM will be given at 300-400μg/kg/day over 3 days (to the nearest whole tablet). IVM will also be taken on an empty stomach with water. Ivermectin 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.
Control
NO INTERVENTIONThe control/standard of care arm will consist of the standard malaria control measures provided by the malaria programme, including case management and long-lasting insecticidal nets (LLINs).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Malaria Consortium
Ouagadougou, BP 01, Burkina Faso
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jane Achan, PhD
Malaria Consortium
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2023
First Posted
July 14, 2023
Study Start
July 15, 2023
Primary Completion
May 31, 2024
Study Completion
December 31, 2024
Last Updated
November 22, 2023
Record last verified: 2023-07