ISRCTN84408319
Completed
未知
Multicentre, open-label randomised clinical trial of efficacy and tolerability of the fixed-dose artesunate/amodiaquine (AS/AQ) combination therapy and amodiaquine (AQ) monotherapy for treatment of uncomplicated falciparum malaria in India
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)0 sites300 target enrollmentJanuary 30, 2008
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
- Enrollment
- 300
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Children and adults from 6 months to 60 years of age, both genders
- •2\. For children: body weight greater than 5 kg
- •3\. Uncomplicated falciparum malaria
- •4\. Axillary temperature greater than 37\.5°C
- •5\. P. falciparum parasitaemia 1000 \- 100,000 asexual forms/µL
- •6\. Ability to swallow oral medication
- •7\. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule
- •8\. Written informed consent (participant or parent/guardian)
Exclusion Criteria
- •1\. Presence of general danger signs among the children less than 5 years old or other signs of severe and complicated falciparum malaria according to current World Health Organization (WHO) definitions
- •2\. Mixed or mono\-infection with another Plasmodium species
- •3\. Presence of severe malnutrition
- •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 disease (e.g. cardiac, renal, hepatic diseases, human immunodeficiency virus \[HIV]/acquired immune deficiency syndrome \[AIDS])
- •5\. History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment
- •6\. Positive pregnancy test or lactating
- •7\. H/O antimalarial treatment in past 15 days
Outcomes
Primary Outcomes
Not specified
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