Efficacy of artemether-lumefantrine treatment in uncomplicated malaria (Plasmodium falciparum) patients and in-vitro experiment on susceptibility of malaria (P. falciparum) strains to new chemical substances

Completed

• Conditions: ncomplicated P. falciparum malaria infection; Infections and Infestations; Plasmodium falciparum malaria

• Registration Number: ISRCTN08391109
• Lead Sponsor: Medicines for Malaria Venture (MMV) (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Male or female aged greater than 1 year
2. Fever (axillary, 37.5ºC) on admission, or reported history of fever within the last 72 hours (3 days)
3. Willingness to participate in particular to stay at the hospital for the first 7 days
4. Full written informed consent (signed) provided by themselves or by attending relatives
5. Signed pre-consent if patient was referred from a district hospital or dispensary
6. Willing to stay under close medical supervision at the hospital for the study duration of at 7 days, and willingness to participate weekly until the 6th week (42 days follow-up)

Exclusion Criteria

1. Pregnancy: all females (aged 12 - 50 years) are required to have a negative pregnancy test (urine) or are currently using an acceptable method of contraception
2. Lactating mother
3. Intake of anti-malarial drugs for the last 3 days (reported on admission, urine samples for confirmation)
4. Mixed malaria infection on admission, i.e. P. falciparum and any other Plasmodium species
5. A previous history of intolerance or hypersensitivity to the study drugs artemether-lumefantrine or to drugs with similar chemical structures, such as artemether, artemisinin or dihydroartemisinin and lumefantrine-like compounds
6. History of significant cardiovascular, liver or renal functional abnormality or any other clinically significant illness
7. Symptoms of severe vomiting
8. Signs or symptoms of severe malaria (World Health Organization [WHO] 2003)
9. Unable to follow the protocol
10. Age of 12 months and below

Study & Design

• Study Type: Interventional
• Study Design: Not specified