None listed
Conditions
Brief summary
Therapeutic efficacy testing of artemether/lumefantrine and artesunate+sulfadoxine/pyrimethamine combination therapies for the treatment of uncomplicated P. falciparum infections in Somalia.
Interventions
Assessing the efficacy of artesunate+sulfadoxine/pyrimethamine (SP) combination therapy for the treatment of uncomplicated P. falciparum infections in one site (Jamame) in Somalia. Patients will be treated with artesunate (4mg/kg over 3 days) co-administered with sulfadoxine/pyrimethamine (single dose of 25mg sulfadoxine/1.25mg pyrimethamine per kg on day 0). Medicine will be administered orally.
Sponsors
Ministry of Health and Human Services
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 60 Years
Healthy volunteers
No
Inclusion criteria
1. age between 6 months and 60 years with the exception of 12-18 years old female minors and unmarried females above 18 years; 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 500 - 200000/microlitre asexual forms; 4. presence of axillary temperature equal to or greater than 37.5 degrees C or history of fever during the past 24 hours; 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. a positive pregnancy test or breastfeeding; 8. Unable to or unwilling to take a pregnancy test or contraceptives.
Outcome results
None listed