Efficacy and safety of artesunate/amodiaquine and Artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in three sites in South Suda
- Conditions
- MalariaInfection - Studies of infection and infectious agents
- Registration Number
- ACTRN12612000938808
- Lead Sponsor
- Ministry of Health of the Republic of South Sudan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 540
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.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent of treatment failures (early treatment failure + late clinical failure + late parasitological failure)<br><br>Enrolled patients will be assessed for parasitological (using microscopy), clinical responses during the 28 days follow-up and treatment outcomes will be classified according to the latest WHO protocol.[At day 28 following initiation of treatment]
- Secondary Outcome Measures
Name Time Method