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Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

ConditionPediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age1-17
SponsorNationwide Children's Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 40 weeks corrected gestational age to < 18 years; AND

Admission to the PICU or CICU; AND

Onset of ≥ 2 new organ dysfunctions within the last 3 calendar days (compared to pre-sepsis baseline) as measured by the modified Proulx criteria; AND

Documented or suspected infection as the MODS inciting event.

Disqualifiers

Weight <3kg; OR

Limitation of care order at the time of screening; OR

Patients at high likelihood of progression to brain death in opinion of the clinical team; OR

Moribund condition in which the patient is unlikely to survive the next 48 hours in opinion of the clinical team; OR

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anakinra

    Drug

    See information in arm/group descriptions

  • Placebo

    Drug

    See information in arm/group descriptions

Treatment groups

500 Participants
are divided into 5 treatment groups
Group A: Anakinra 4 mg/kg/dayActive comparator 1 intervention
Group B: Anakinra 8 mg/kg/dayActive comparator 1 intervention
Group C: Anakinra 12 mg/kg/dayActive comparator 1 intervention
Group D: Anakinra 16 mg/kg/dayActive comparator 1 intervention
Group E: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative 28-day Pediatric Logistic Organ Dysfunction (PELOD-2) score

The cumulative Pediatric Logistic Organ Dysfunction (PELOD)-2 score over 28 days from randomization. The range of daily PELOD-2 scores is from 0 - 33, with higher scores representing worse organ function.

Time frame
28 days from randomization

Secondary outcomes

1

3-month health-related quality of life

The change in Pediatric Quality of Life inventory (PedsQL) score from baseline to 3-months post-randomization. The PedsQL score ranges from 0 - 100, with higher values indicating better quality of life.

Time frame
3 months post-randomization
2

3-month functional status

The change in Functional Status Score (FSS) from baseline to 3-months post-randomization. The FSS score ranges from 6 - 30, with higher scores indicating worse functional status.

Time frame
3 months post-randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nationwide Children's Hospital

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov
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