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Efficacy of antimalarials (Artemether/Lumefantrine and Dihydroartemisinine/Piperaquine) used in Burkina Faso for the treatment of malaria in children

Efficacy and safety of two artemisinin based combination therapies (CTAs) for the treatment of uncomplicated Plasmodium falciparum malaria in Burkina Faso

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201708002499311
Enrollment
720
Registered
2017-08-03
Start date
2017-09-11
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Malaria

Interventions

Dihydroartemisinine/piperaquine

Sponsors

Improving Malaria Care (IMC Project)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age, 6¿59 months, Mono-infection with P. falciparum detected by microscopy; Asexual parasite count of 2000¿200 000/¿l Axillary temperature ¿ 37.5 °C or history of fever during the previous two weeks; Hemoglogin ¿ 8g/dl Ability to swallow oral medication; Ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule; Informed consent from a parent or guardian in the case of children

Exclusion criteria

Exclusion criteria: Presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO Body weight less than 5 kg; Presence of severe malnutrition (defined as a child whose growth standard is below ¿3 z-score); Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea withdehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS); Regular medication, which may interfere with antimalarial pharmacokinetics; History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s) Known individual or familly history of clinically significant prolonged QTc or subite death Previous particpation to malaria vaccine trial

Design outcomes

Primary

MeasureTime frame
Adequate clinical and parasitological response at day 28 PCR-corrected.;Late treatment failure;Early treatment failure

Secondary

MeasureTime frame
Adequate clinical and parasitological response at day 42, PCR-corrected.;Fever clearance;Parasite clearance;Nature and incidence of adverse events

Countries

Burkina Faso

Contacts

Public ContactOusmane Badolo
Ousmane.Badolo@jhpiego.org+226 70 25 34 00

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 16, 2026