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Published on: January 16, 2015
Adjunctive rosiglitazone treatment for severe pediatric malaria: A randomized placebo-controlled trial in Mozambican
Rosauro Varo1, Valerie M Crowley2, Humberto Mucasse3
1ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain; Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.
Insights
Adjunctive rosiglitazone treatment for severe malaria in children did not significantly lower angiopoietin-2 (Angpt-2) levels. The treatment was safe and well-tolerated but did not improve key malaria outcomes.
Area of Science:
- Malariology
- Pharmacology
- Pediatrics
Background:
- Severe malaria in children is associated with elevated angiopoietin-2 (Angpt-2), a marker of endothelial activation.
- Understanding factors influencing Angpt-2 kinetics is crucial for improving treatment strategies.
Purpose of the Study:
- To evaluate the efficacy of adjunctive rosiglitazone in reducing circulating Angpt-2 levels in Mozambican children with severe malaria.
- To assess the impact of rosiglitazone on angiopoietin-1 (Angpt-1) and the Angpt-2/Angpt-1 ratio.
- To determine the effect on clinical outcomes and safety metrics.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted.
- 180 children with severe malaria received either rosiglitazone (0.045 mg/kg/dose twice daily for 4 days) or placebo, alongside standard artesunate treatment.
- Primary endpoint: rate of Angpt-2 decline over 96 hours; secondary endpoints: Angpt-1 dynamics, parasite clearance, clinical outcomes, and safety.
Main Results:
- Rosiglitazone treatment showed a non-significant trend towards a steeper decline in Angpt-2 levels compared to placebo (P=0.28).
- Similar non-significant trends were observed for Angpt-1 and the Angpt-2/Angpt-1 ratio.
- No significant differences were found in other secondary outcomes or safety parameters between the groups.
Conclusions:
- Adjunctive rosiglitazone, at the tested dosage, was found to be safe and well-tolerated in children with severe malaria.
- The treatment did not significantly alter the longitudinal kinetics of circulating Angpt-2 or improve other measured outcomes.
Objectives:
We tested the hypothesis that adjunctive rosiglitazone treatment would reduce levels of circulating angiopoietin-2 (Angpt-2) and improve outcomes of Mozambican children with severe malaria.
Methods:
A randomized, double-blind, placebo-controlled trial of rosiglitazone vs placebo as adjunctive treatment to artesunate in children with severe malaria was conducted. A 0.045 mg/kg/dose of rosiglitazone or matching placebo were administered, in addition to standard of malaria care, twice a day for 4 days. The primary endpoint was the rate of decline of Angpt-2 over 96 hours. Secondary outcomes included the longitudinal dynamics of angiopoietin-1 (Angpt-1) and the Angpt-2/Angpt-1 ratio over 96 hours, parasite clearance kinetics, clinical outcomes, and safety metrics.
Results:
Overall, 180 children were enrolled; 91 were assigned to rosiglitazone and 89 to placebo. Children who received rosiglitazone had a steeper rate of decline of Angpt-2 over the first 96 hours of hospitalization compared to children who received placebo; however, the trend was not significant (P = 0.28). A similar non-significant trend was observed for Angpt-1 (P = 0.65) and the Angpt-2/Angpt-1 ratio (P = 0.34). All other secondary and safety outcomes were similar between groups (P >0.05).
Conclusion:
Adjunctive rosiglitazone at this dosage was safe and well tolerated but did not significantly affect the longitudinal kinetics of circulating Angpt-2.
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