ISRCTN45665690CompletedNot Applicable
Efficacy and safety of artesunate and sulfadoxine-pyrimethamine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in low to moderate sentinel sites in Suda
World Health Organization (WHO)/HIV/AIDS, Tuberculosis and Malaria (HTM) - Global Malaria Programme0 sites180 target enrollmentStarted: August 15, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 180
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Aged over 6 months old
- •2. Infection with P. falciparum
- •3. Parasitaemia, 1000 - 100 000 asexual forms per µl
- •4. Axillary temperature of 37.5°C or oral/rectal temperature of 38°C
- •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 the patient or from a parent or guardian in case of children
Exclusion Criteria
- •1. Presence of general danger signs among children less than 5 years old or other signs of severe and complicated falciparum malaria according to current WHO definitions
- •2. Mixed or mono-infection with another Plasmodium species
- •3. Presence of severe malnutrition (defined as a child whose weight-for-height is below -3 standard deviation or who has symmetrical oedema involving at least the feet)
- •4. Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhoea with dehydration, etc.), or other known underlying chronic or severe diseases
- •5. History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment
- •6. Pregnancy or lactation
Investigators
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