Related Experiment Video
Updated: Jul 14, 2026
08:46
A Neonatal Imaging Model of Gram-Negative Bacterial Sepsis
Published on: August 12, 2020
RESOLVE-ing sepsis in children--not yet!
1Paediatric Intensive Care, St Mary's Hospital and Imperial College, London W2 1NY, UK. s.nadel@imperial.ac.uk
Critical Care (London, England)
|June 15, 2007
Summary
The largest pediatric severe sepsis trial found no benefit of drotrecogin alpha activated over placebo. This highlights challenges in designing clinical trials for rare pediatric conditions with infrequent outcomes.
Area of Science:
- Pediatric critical care medicine
- Pharmacological interventions
- Clinical trial design
Background:
- Severe sepsis is a life-threatening condition in children.
- Adjunctive therapies are explored to improve outcomes.
- Drotrecogin alpha activated was investigated as a potential treatment.
Purpose of the Study:
- To evaluate the efficacy of drotrecogin alpha activated as an adjunctive therapy in children with severe sepsis.
- To assess the impact on mortality and organ dysfunction.
Main Methods:
- A large-scale, global clinical trial comparing drotrecogin alpha activated to placebo.
- Inclusion of pediatric patients diagnosed with severe sepsis.
- Focus on clinically relevant outcomes.
Main Results:
- No statistically significant difference in outcomes between the drotrecogin alpha activated group and the placebo group.
- The study failed to demonstrate a therapeutic benefit.
Conclusions:
- Current adjunctive therapies, including drotrecogin alpha activated, may not be effective for pediatric severe sepsis.
- Rethinking clinical trial methodologies is crucial for rare pediatric diseases.
- Future research should focus on innovative trial designs for conditions with infrequent endpoints.
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