Overview

This trial is active, not recruiting.

Condition cerebral malaria
Treatment intrarectal quinine
Phase phase 3
Sponsor Makerere University
Collaborator Sanofi-Synthelabo
Start date September 2003
End date January 2004
Trial size 108 participants
Trial identifier NCT00124267, 2001/HD11/524/RQ

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
Parasite clearance time
time frame:

Secondary Outcomes

Measure
Fever clearance time
time frame:
Coma recovery time
time frame:
Time to sit unsupported
time frame:
Time to begin oral intake
time frame:
Mortality
time frame:
Neurological sequelae
time frame:
Adverse drug events
time frame:

Eligibility Criteria

Male or female participants from 6 months up to 5 years old.

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.

Additional Information

Official title Efficacy of Intrarectal Versus Intravenous Quinine for the Treatment of Childhood Cerebral Malaria: a Randomized Clinical Trial
Principal investigator Jane Achan, MBChB
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 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. A few studies in Francophone Africa have reported clinical efficacy and tolerance of intrarectal quinine. Although the studies were randomized trials, they were not blinded and did not use the WHO definition of cerebral malaria as selection criteria. The current study aims to establish whether intrarectal quinine is as effective and as safe as intravenous quinine in the treatment of childhood cerebral malaria. To address the shortcomings of the Francophone African studies, the investigators have designed a randomized, double blind placebo controlled clinical trial to include patients who meet the WHO definition of cerebral malaria. Hypothesis: Intrarectal quinine (15mg/kg every 8 hours) given to children with cerebral malaria, will lead to a shorter parasite clearance time (39.9 hours) than intravenous quinine (55.0 hours). The investigators calculated a sample size of 54 patients in each group for 90% power and 95% confidence. In the calculation, the researchers assumed that the children receiving intrarectal quinine would have a mean parasite clearance time of 39.9 (SD 24.3) hours and those receiving intravenous quinine would have a mean parasite clearance time of 55.0(SD 24.3) hours (27.5% effect size), according to a study by Aceng, Byarugaba and Tumwine in the same hospital.
Trial information was received from ClinicalTrials.gov and was last updated in August 2005.
Information provided to ClinicalTrials.gov by Makerere University.