Status:
UNKNOWN
Efficacy of Intrarectal Versus Intravenous Quinine for the Treatment of Childhood Cerebral Malaria
Lead Sponsor:
Makerere University
Collaborating Sponsors:
Sanofi-Synthelabo
Ministry of Health, Uganda
Conditions:
Cerebral Malaria
Eligibility:
All Genders
6-5 years
Phase:
PHASE3
Brief Summary
Cerebral malaria is the most lethal complication of P.falciparum infection with a mortality rate between 5 and 40%. Intravenous quinine remains the recommended treatment for cerebral malaria. However ...
Detailed Description
Cerebral malaria is the most lethal complication of P.falciparum infection with a mortality rate between 5 and 40%. Intravenous quinine remains the recommended treatment for cerebral malaria. However ...
Eligibility Criteria
Inclusion
- Children aged 6 months to 5 years admitted to Mulago hospital during the study period who satisfy the World Health Organization (WHO) case definition of cerebral malaria (Unarousable coma lasting more than 30 minutes after a seizure, with peripheral asexual P.falciparum parasitaemia and absence of other causes of coma) and whose caretakers give informed consent.
Exclusion
- Patients with diarrhea (more than 4 motions/24 hours)
- Any recent anal pathology (such as rectal bleeding, rectal prolapse)
- Documented quinine treatment in previous 48 hours.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2004
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00124267
Start Date
September 1 2003
End Date
January 1 2004
Last Update
August 4 2005
Active Locations (1)
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1
Mulago Hospital
Kampala, Kampala, Uganda, 7051