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Sponsors and Collaborators: |
Makerere University Sanofi-Synthelabo Ministry of Health, Uganda |
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Information provided by: | Makerere University |
ClinicalTrials.gov Identifier: | NCT00124267 |
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.
Condition | Intervention | Phase |
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Cerebral Malaria |
Drug: Intrarectal quinine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of Intrarectal Versus Intravenous Quinine for the Treatment of Childhood Cerebral Malaria: a Randomized Clinical Trial |
Estimated Enrollment: | 108 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | January 2004 |
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.
Ages Eligible for Study: | 6 Months to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Uganda | |
Mulago Hospital | |
Kampala, Uganda, 7051 |
Principal Investigator: | Jane Achan, MBChB | Department of Paediatrics and Child Health, Makerere University |
Study ID Numbers: | 2001/HD11/524/RQ |
Study First Received: | July 26, 2005 |
Last Updated: | August 3, 2005 |
ClinicalTrials.gov Identifier: | NCT00124267 History of Changes |
Health Authority: | Uganda: National Council for Science and Technology |
Cerebral malaria intra-rectal quinine |
children Uganda efficacy safety |
Protozoan Infections Malaria, Cerebral Quinine Central Nervous System Diseases Malaria Malaria, Falciparum Antimalarials |
Central Nervous System Infections Analgesics, Non-Narcotic Muscle Relaxants, Central Parasitic Diseases Peripheral Nervous System Agents Analgesics |
Anti-Infective Agents Antiprotozoal Agents Quinine Physiological Effects of Drugs Malaria Neuromuscular Agents Central Nervous System Parasitic Infections Antimalarials Antiparasitic Agents Sensory System Agents Therapeutic Uses Muscle Relaxants, Central Parasitic Diseases |
Analgesics Protozoan Infections Malaria, Cerebral Coccidiosis Nervous System Diseases Central Nervous System Diseases Pharmacologic Actions Malaria, Falciparum Central Nervous System Protozoal Infections Central Nervous System Infections Analgesics, Non-Narcotic Peripheral Nervous System Agents Central Nervous System Agents |