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

Completed

• Conditions: Malaria; Infections and Infestations

• Registration Number: ISRCTN45665690
• Lead Sponsor: World Health Organization (WHO)/HIV/AIDS, Tuberculosis and Malaria (HTM) - Global Malaria Programme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-15
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 180

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified