A clinical trial of patient adherence and treatment outcome in supervised versus non-supervised artesunate/sulphadoxine - pyrimethamine treatment in uncomplicated falciparum malaria
- Conditions
- Health Condition 1: null- Uncomplicated Plasmodium falciparum malaria
- Registration Number
- CTRI/2014/10/005105
- Lead Sponsor
- Dr Chiranjib Bagchi Calcutta School of Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 62
Inclusion Criteria
•Presence of acute symptomatic uncomplicated malaria with a diagnosis confirmed by a positive blood smear with asexual forms of P falciparum parasites only (without mixed infection).
•Only those of the above patients considered eligible by the physician at the Malaria Clinic, for dispensation of AS-SP plus primaquine treatment as per the national guidelines (NVBDCP).
•Adult patients (age > 18 years) â?? both sexes
•Patients willing to give informed consent.
•Patients considered able to comply with the study protocol for the duration of the study.
•Patients residing within a reasonable distance of the site, so that attendance of all study visits and follow-up by medical staff are logistically feasible.
Exclusion Criteria
•Mixed infection with another Plasmodium species at the time of presentation (including P vivax, P ovale and P malariae)
•Known allergy to artesunate, artemisinin derived products, sulphadoxine, pyremethamine, primaquine or any other related drugs.
•G6PD deficiency as investigated by the G6PD test
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adherence of patients to artesunate/sulphadoxine-pyrimethamine treatmentTimepoint: Adherence, <br/ ><br>Serum antimalarial estimation- on Day 3
- Secondary Outcome Measures
Name Time Method Compare efficacy and tolerabilityTimepoint: Day 0,3,7,28