Molecular Surveillance of Artemisinin Resistance Markers and Impact on Treatment Outcome in Patients with Acute Uncomplicated Plasmodium falciparum Malaria in South-West Nigeria
Phase 4
Recruiting
- Conditions
- Malaria
- Registration Number
- PACTR202108584742856
- Lead Sponsor
- Amusan Abiodun
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
(i) Age 1 to 15 years with symptoms compatible with acute uncomplicated Plasmodium falciparum infection (ii) P. falciparum parasitemia = 2,000 asexual forms of parasite per µL of blood,
(iii) Body (axillary) temperature = 37.5°C, or history of fever within one to two days preceding presentation,
(iv) Absence of other concomitant illnesses,
(v) Absence of any history of antimalarial drug use within 2 weeks prior to presentation,
(vi) Written informed consent from parents or guardians of participants.
Exclusion Criteria
(i) severe malaria,
(ii) severe malnutrition,
(iii) serious underlying diseases (renal, cardiac, or hepatic),
(iv) known allergic reaction to study drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment success or failure
- Secondary Outcome Measures
Name Time Method Response of patient to treatment will be classified as follows: (i) adequate clinical and parasitological response (ACPR), (ii) late parasitological failure (LPF), (iii) late clinical failure (LCF) and (iv) early treatment failure (ETF), (v) Slow clearance will be defined as failure to clear parasitemia by day 3 (WHO, 2018). <br>