Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

Phase 2/3 Recruiting 500 enrolled Nationwide Children's Hospital Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The TRIPS study is a prospective, multi-center, double-blind, adaptively randomized, placebo-controlled clinical trial of the drug anakinra for reversal of moderate to severe hyperinflammation in children with sepsis-induced multiple organ dysfunction syndrome (MODS).

Timeline

Start: 2022-06-14
Primary completion: 2028-05-15
Completion: 2028-08-31

Publications

VanBuren JM, Hall M, Zuppa AF, Mourani PM, Carcillo J, Dean JM, Watt K, Holubkov R. The Design of Nested Adaptive Clinical Trials of Multiple Organ Dysfunction Syndrome Children in a Single Study. Pediatr Crit Care Med. 2023 Dec 1;24(12):e635-e646. doi: 10.1097/PCC.0000000000003332. Epub 2023 Jul 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Anakinra	Protein / enzyme biologic	4 mg/kg	Intravenous
Comparator	Anakinra	Protein / enzyme biologic	8 mg/kg	Intravenous
Comparator	Anakinra	Protein / enzyme biologic	12 mg/kg	Intravenous
Comparator	Anakinra	Protein / enzyme biologic	16 mg/kg	Intravenous

Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

Summary

Timeline

Publications

Drugs

Indications