None listed
Conditions
Brief summary
Title: Assessment of parasite clearance rate in Plasmodium falciparum malaria induced by Artesunate in Guyana. Purpose: To assess the efficacy, including parasite clearance time, and safety of artesunate 7 day treatment for uncomplicated falciparum malaria Objective: To assess the efficacy, including parasite clearance time, and safety 7 days artesunate for the treatment of uncomplicated P. falciparum malaria infections Study Sites: study was conducted in Malaria Clinic, Georgetown, Guyana Study Period: The study was conducted from March to December 2014 Study Design: Single arm prospective study. Patient population: Febrile patients aged 2 years and above with confirmed uncomplicated P. falciparum infection Sample Size: 50 patients. Treatments and follow-up: Artesunate (daily dose for 7 days) was be given. Clinical and parasitological parameters was monitored over a 28-day follow-up period to evaluate drug efficacy and safety. Primary endpoints: (i) the proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy; (ii) the proportion of patients positive on day 3 and parasite clearance time; Recrudescence was to be distinguished from re-infection by polymerase chain reaction (PCR) analysis. Secondary endpoints: 1. The frequency of adverse events. 2. Frequency of molecular markers for artemisinin resistance (K13)
Interventions
To assess the efficacy and safety of artesunate (4 mg/kg body weight) once daily for 7 consecutive days) for the treatment of uncomplicated P. falciparum infection.. The treatment was taken orally under direct supervision by the health worker. The drug was tested in one site. Eligibile subjects were treated for 7 days days and followed up for 28 days.
Sponsors
Regional Office for the Americas of the World Health Organization
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
2 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. age greater or equal to 2 years; 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 1000–100,000/microliter asexual forms; 4. presence of axillary temperature greater or equal to 37.5 degrees C or history of fever during the past 24 h 5. ability to swallow oral medication; 6. ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; 7. informed consent from patients or parent or guardian of children.
Exclusion criteria
1. presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO; 2. mixed or mono-infection with another Plasmodium species detected by microscopy; 3. presence of severe malnutrition defined as a child aged 6-60 months has a mid-upper arm circumference belo 115 mm) 4. presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS); 5. regular medication, which may interfere with antimalarial pharmacokinetics; 6. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); 7. a positive pregnancy test or breastfeeding (include this criterion only if adults are included); 8. unable to or unwilling to take a pregnancy test or contraceptives (for women of child-bearing age); 9. previous antimalarial drug intake in the past 48 hours; 10. Patients presenting with splenectomy.
Outcome results
None listed