Efficacy and safety of rectal artesunate in paediatric patients - a randomised controlled study (Ghana and Tanzania)
Completed
- Conditions
- MalariaInfections and Infestations
- Registration Number
- ISRCTN78768405
- Lead Sponsor
- ICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 246
Inclusion Criteria
1. Aged 3 to 24 months
2. Suspected malaria with no other obvious cause of illness
3. P. falciparum asexual parasitaemia greater than ++ (5 - 10 parasites/High Power Field [HPF])
4. Unable to eat, suck or drink, or repeatedly vomiting (more than three episodes over past 24 hours); or prostrate (unable to sit or stand if previously able to do so)
5. History of convulsions over the preceding 24 hours or impaired consciousness (Blantyre Coma Score less than five)
6. Parent/guardian informed consent
Exclusion Criteria
1. Ability to tolerate oral intake
2. Acute diarrhoea defined as the presence of more than three episodes of watery stools in the preceding 24 hours
3. History of allergy to artemisinin compounds and/or quinine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 28-day disease-free survival, defined as patients who survived the 28-day period of follow-up with the peripheral blood free of the original genotype of malaria parasites.
- Secondary Outcome Measures
Name Time Method The parasitological outcomes and tolerability of a single dose of the rectal artesunate in children aged 3 to 24 months with non per os falciparum malaria.