A Randomized Open Label Clinical Trial to Compare the Efficacy and Safety of Intravenous Quinine Followed by Oral Malarone vs. Intravenous Quinine Followed by Oral Quinine in the Treatment of Severe Malaria
Source: Journal of Tropical Pediatrics, Volume 51, Number 1, February 2005 , pp. 17-24(8)
Publisher: Oxford University Press
Abstract:The treatment of patients with severe malaria in sub-Saharan Africa has become a challenge to clinicians due to poor compliance to quinine and the increasing multidrug resistance to antimalarials by the P. falciparum parasite. The aim of this study was to compare the efficacy and safety profile of two truncated antimalarial regimens of intravenous quinine followed by oral Malarone (Malarone arm) with intravenous quinine followed by oral quinine (quinine arm) in the treatment of severe P. falciparum malaria. The outcome measures were parasite clearance time, fever clearance time, efficacy, and adverse events profile. Consecutive patients aged 1–60 years, with a diagnosis of severe malaria with positive blood smears for P. falciparum parasites and admitted to the Moi Teaching and Referral Hospital were randomized into the two study arms. Of the 360 patients studied 167 and 193 cases were randomized into the Malarone and quinine arms, respectively. Of the five (1.4 per cent) patients who died, three came from the quinine arm. The frequency of adverse reactions was higher in the oral quinine group (31.6 per cent) than in the Malarone group (25.7 per cent). The mean parasite clearance time was 120 h and 108 h for the quinine and Malarone arms of the study, respectively, and the mean fever clearance times were 84 h and 72 h for the quinine and Malarone arms, respectively (p = 0.1). Truncated therapeutic regimen using malarone after intravenous quinine is safer and as effective as conventional intravenous quinine followed by oral quinine in the treatment of severe malaria. The P. falciparum recrudescence rate was lower with the use of Malarone than for quinine.
Document Type: Research Article
Affiliations: 1: Department of Child Health and Paediatrics, Faculty of Health Sciences, Moi University, Kenya, 2: Department of Medicine, Faculty of Health Sciences, Moi University, Kenya, 3: Department of Microbiology and Parasitology, Faculty of Health Sciences, Moi University, Kenya, 4: Moi Teaching and Referral Hospital, Eldoret, Kenya
Publication date: February 2005
- The Journal of Tropical Pediatrics provides a link between theory and practice in the field. Papers report key results of clinical and community research, and considerations of programme development. More general descriptive pieces are included when they have application to work preceeding elsewhere. The journal also presents review articles, book reviews and, occasionally, short monographs and selections of important papers delivered at relevant conferences.