Efficacy of Intrarectal Versus Intravenous Quinine for the Treatment of Childhood Cerebral Malaria

• Status: Unknown status
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

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 its administration is often not feasible due to lack of simple equipment or trained staff. When referral is not possible, a viable alternative is needed. The intrarectal route is of interest in children since it is painless and simple. Studies of the efficacy of intrarectal quinine in the treatment of cerebral malaria are limited. The study aims to establish the efficacy of intrarectal quinine in the treatment of childhood cerebral malaria.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Makerere University
• Collaborators: Ministry of Health, Uganda; Sanofi-Synthelabo
• Treatments: Quinine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.