OBJECTIVE: To compare the efficacy and safety of rectal artemether with intravenous quinine in the treatment of cerebral malaria in children. DESIGN: Randomised, single blind, clinical trial. SETTING:Acute care unit at Mulago Hospital, Uganda's national referral and teaching hospital in Kampala. PARTICIPANTS: 103 children aged 6 months to 5 years with cerebral malaria. INTERVENTION: Patients were randomised to either intravenous quinine or rectal artemether for seven days. MAIN OUTCOME MEASURES: Time to clearance of parasites and fever; time to regaining consciousness, starting oral intake, and sitting unaided; and adverse effects. RESULTS: The difference in parasitological and clinical outcomes between rectal artemether and intravenous quinine did not reach significance (parasite clearance time 54.2 (SD 33.6) hours v 55.0 (SD 24.3) hours, P = 0.90; fever clearance time 33.2 (SD 21.9) hours v 24.1(SD 18.9 hours, P = 0.08; time to regaining consciousness 30.1 (SD 24.1) hours v 22.67 (SD 18.5) hours, P = 0.10; time to starting oral intake 37.9 (SD 27.0) hours v 30.3 (SD 21.1) hours, P = 0.14). Mortality was higher in the quinine group than in the artemether group (10/52 v 6/51; relative risk 1.29, 95% confidence interval 0.84 to 2.01). No serious immediate adverse effects occurred. CONCLUSION: Rectal artemether is effective and well tolerated and could be used as treatment for cerebral malaria.
RCT Entities:
OBJECTIVE: To compare the efficacy and safety of rectal artemether with intravenous quinine in the treatment of cerebral malaria in children. DESIGN: Randomised, single blind, clinical trial. SETTING: Acute care unit at Mulago Hospital, Uganda's national referral and teaching hospital in Kampala. PARTICIPANTS: 103 children aged 6 months to 5 years with cerebral malaria. INTERVENTION: Patients were randomised to either intravenous quinine or rectal artemether for seven days. MAIN OUTCOME MEASURES: Time to clearance of parasites and fever; time to regaining consciousness, starting oral intake, and sitting unaided; and adverse effects. RESULTS: The difference in parasitological and clinical outcomes between rectal artemether and intravenous quinine did not reach significance (parasite clearance time 54.2 (SD 33.6) hours v 55.0 (SD 24.3) hours, P = 0.90; fever clearance time 33.2 (SD 21.9) hours v 24.1(SD 18.9 hours, P = 0.08; time to regaining consciousness 30.1 (SD 24.1) hours v 22.67 (SD 18.5) hours, P = 0.10; time to starting oral intake 37.9 (SD 27.0) hours v 30.3 (SD 21.1) hours, P = 0.14). Mortality was higher in the quinine group than in the artemether group (10/52 v 6/51; relative risk 1.29, 95% confidence interval 0.84 to 2.01). No serious immediate adverse effects occurred. CONCLUSION: Rectal artemether is effective and well tolerated and could be used as treatment for cerebral malaria.
Authors: Eric A F Simoes; Stefan Peterson; Youssouf Gamatie; Felix S Kisanga; Gelasius Mukasa; Jesca Nsungwa-Sabiiti; M Wilson Were; Martin W Weber Journal: Bull World Health Organ Date: 2003-09-03 Impact factor: 9.408
Authors: K I Barnes; J Mwenechanya; M Tembo; H McIlleron; P I Folb; I Ribeiro; F Little; M Gomes; M E Molyneux Journal: Lancet Date: 2004-05-15 Impact factor: 79.321
Authors: Grant Dorsey; Denise Njama; Moses R Kamya; Adithya Cattamanchi; Daniel Kyabayinze; Sarah G Staedke; Anne Gasasira; Philip J Rosenthal Journal: Lancet Date: 2002 Dec 21-28 Impact factor: 79.321
Authors: Adoke Yeka; Anne Gasasira; Arthur Mpimbaza; Jane Achan; Joaniter Nankabirwa; Sam Nsobya; Sarah G Staedke; Martin J Donnelly; Fred Wabwire-Mangen; Ambrose Talisuna; Grant Dorsey; Moses R Kamya; Philip J Rosenthal Journal: Acta Trop Date: 2011-03-21 Impact factor: 3.112