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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202007754558749
Enrollment
345
Registered
2020-07-31
Start date
2020-09-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Interventions

DHA PQ plus Albendazol
SP AQ plus Albendazole
Albendazole

Sponsors

Universite des Sciences des Techniques et des Technologies de Bamako USTTB
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: Children who do not meet all the inclusion criteria

Design outcomes

Primary

MeasureTime frame
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;School performance of children

Secondary

MeasureTime frame
Prevalence of P. falciparum gametocyte in school aged-children at cross sectional surveys;Prevalence of malaria infection in school aged-children at cross sectional surveys;Prevalence of adverse events in DHA-PQ group, compared to SP-AQ group and control group;Prevalence of molecular markers of resistance to SP, AQ, DHA-PQ after SMC ;Incidence of all causes of morbidity in school aged children

Countries

Mali

Contacts

Public ContactDrissa Coulibaly

Clinical coordinator

coulibalyd@icermali.org+22320228109

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026