None listed
Conditions
Brief summary
Efficacy and safety of artesunate/amodiaquine and artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in three sites in South Sudan
Interventions
To assess the efficacy and safety of artesunate/amodiaquine (standard dose of 30mg/kg of amodiaquine (10mg/kg x 3 times per day for 3 days) and 12mg/kg of artesunate (4mg/kg x 3 times per day for 3 days) for the treatment of uncomplicated P. falciparum infection. The treatment will be taken orally. Eligibile subjects will be treated for three days and followed up for 28 days.
Sponsors
Ministry of Health of the Republic of South Sudan
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 59 Months
Healthy volunteers
No
Inclusion criteria
1. age between 6 to 59 months; 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 1000-200,000/microlitre asexual forms; 4. presence of axillary (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; and 7. informed consent from the patient or from a parent or guardian of children.
Exclusion criteria
1. presence of general danger signs or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1) in children (aged 6- 59 months); 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 < 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).
Outcome results
None listed