Intermittent Preventive Treatment: efficacy and safety of sulfadoxine-pyrimethamine and sulfadoxine-pyrimethamine plus piperaquine in schoolchildren.
- Conditions
- Malaria
- Registration Number
- PACTR201211000449232
- Lead Sponsor
- niversity of Antwerp
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 1100
males and females primary school children,
anticipated local residence for the study duration,
signed or thumb-printed informed consent by the parents or guardians and witnessed by an impartial witness (whenever parents/guardians are illiterate)
informed ascent for 12-year children or more
Children of the 6th primary school year
Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.
Known hypersensitivity or serious adverse events (AE) to study drugs.
Clinical malaria at baseline irrespectively of the severity (World Health Organisation malaria treatment guideline 2010) (Annex III).
Febrile conditions caused by diseases other than malaria at first visit.
Clinical symptoms of severe anaemia
Illness or conditions like hematologic, cardiac, renal, hepatic diseases which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency and sickle cell.
Body weight < 14 Kg
Children with major chronic infectious diseases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hemoglobin concentration
- Secondary Outcome Measures
Name Time Method malaria incidence ;Malaria prevalence ;Prevalence of P. falciparum dihydrofolate reductase and dihydropteroate synthase markers;malaria parasitemia;Rate of malnutrition;Educational performance ;School attendance