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Efficacy study of antimalarial drugs in Senegal

Phase 3
Conditions
Malaria
Registration Number
PACTR202003802011316
Brief Summary

A total of 496 patients were enrolled. In Diourbel, PCR non-corrected/corrected adequate clinical and parasitological responses (ACPR) was 100.0% in both AL and ASAQ arms. In Kedougou, PCR corrected ACPR were 98.8%, 100% and 97.6% in AL, ASAQ and DP arms respectively. No Pfk13 or Pfcoronin mutation associated to artemisinin resistance was found. This study showed that AL, ASAQ and DP remain efficacious and well tolerated in the treatment of uncomplicated falciparum malaria in Senegal.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
500
Inclusion Criteria

Patients aged 6 months or above, had an axillary temperature = 37.5 °C at presentation or history of fever during the last 24 hours,
a positive P. falciparum mono-infection parasitemia of 1,000 to 100,000 asexual forms/ul,
ability to swallow oral medication,
ability and willingness to comply with the study protocol and visit schedule for the duration of the study,
written informed consent from the patient or from the parent or guardian for enrolled children

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 ,
mixed or mono-infection with another Plasmodium species detected by microscopy,
positive pregnancy test, severe malnutrition,
febrile conditions due to diseases other than malaria or other known underlying chronic or severe diseases, regular medication, which may interfere with anti-malarial treatment, history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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