# name
Safety and tolerability of adjunctive rosiglitazone treatment
                for children with uncomplicated malaria

# metadata.dc.description.abstract[].value
BACKGROUND: Despite the widespread use and availability of
                rapidly acting anti-malarials, the fatality rate of severe
                malaria in sub-Saharan Africa remains high. Adjunctive therapies
                that target the host response to malaria infection may further
                decrease mortality over that of anti-malarial agents alone.
                Peroxisome proliferator-activated receptor-gamma agonists (e.g.
                rosiglitazone) have been shown to act on several pathways
                implicated in the pathogenesis of severe malaria and may improve
                clinical outcome as an adjunctive intervention. METHODS: In this
                study, the safety and tolerability of adjunctive rosiglitazone
                in paediatric uncomplicated malaria infection was evaluated in
                Mozambique, as a prelude to its evaluation in a randomized
                controlled trial in paediatric severe malaria. The study was a
                prospective, randomized, double-blind, placebo-controlled, phase
                IIa trial of rosiglitazone (0.045 mg/kg/dose) twice daily for 4
                days versus placebo as adjunctive treatment in addition to
                Mozambican standard of care (artemisinin combination therapy
                Coartem(R)) in children with uncomplicated malaria. The primary
                outcomes were tolerability and safety, including clinical,
                haematological, biochemical, and electrocardiographic
                evaluations. RESULTS: Thirty children were enrolled: 20 were
                assigned to rosiglitazone and 10 to placebo. Rosiglitazone
                treatment did not induce hypoglycaemia nor significantly alter
                clinical, biochemical, haematological, or electrocardiographic
                parameters. CONCLUSIONS: Adjunctive rosiglitazone was safe and
                well-tolerated in children with uncomplicated malaria,
                permitting the extension of its evaluation as adjunctive therapy
                for severe malaria. The trial is registered with
                Clinicaltrials.gov, NCT02694874.

# metadata.dc.source[].value
Articles publicats en revistes (ISGlobal)

# metadata.dc.title[].value
Safety and tolerability of adjunctive rosiglitazone treatment
                for children with uncomplicated malaria