None listed
Conditions
Brief summary
Efficacy and safety of artesunate + sulfadoxine+pyrimethamine and artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in three sites in Pakistan
Interventions
To assess the efficacy and safety of artesunate+sulfadoxine-pyrimethamine for the treatment of uncomplicated P. falciparum malaria in three sentinel sites in Pakistan. The daily dose of artesunate (4 mg/kg) over 3 days co-administered with a single dose of sulfadoxine/pyrimethamine (25 mg sulfadoxine/1.25 mg pyrimethamine per kg) on day 0 will be administered orally.
Sponsors
Bannu Medical College
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than 6 months, excluding 12-17 old female minors and unmarried females aged 18 years and above; 2. mono-infection with P. falciparum detected by microscopy; 3. Parasitaemia of 1000 – 250000 / microlitre asexual forms for sites in Sindh, Balochistan and Khyber Pakhtoonkwa. 4. Presence of axillary temperature equal to or greater than 37.5 degrees celsius or history of fever during the past 48 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; and 7. Informed consent from the patient or from a parent or guardian in the case 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 whose growth standard is below –3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference less than 110 mm); 4. Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea 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); and 7. 12-17 old female minors and unmarried females aged 18 years and above;
Outcome results
None listed