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NCT03769844 · ClinicalTrials.gov registry record · Phase 4
GM-CSF for Reversal of immunopAralysis in pediatriC sEpsis-induced MODS Study
A Phase 4 study of Pediatric Sepsis-induced MODS, sponsored by Nationwide Children's Hospital.
- Active
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
- 8
- Study locations
NCT03769844: Active Phase 4 study of Pediatric Sepsis-induced MODS, sponsored by Nationwide Children's Hospital.
NCT03769844 is a Phase 4 study of Pediatric Sepsis-induced MODS that is active but no longer recruiting, run by Nationwide Children's Hospital. The registered enrollment target is 120 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03769844, a Phase 4 study of Pediatric Sepsis-induced MODS, is active but no longer recruiting, sponsored by Nationwide Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
- 8
- Study locations
Study Summary
This study is an open-label, multi-center, interventional trial in which children with sepsis-induced MODS undergo surveillance immune function testing beginning on Day 2 of MODS. Those children who demonstrate immunoparalysis (TNF-alpha response \<200 pg/ml) will receive a 7-day course of GM-CSF at a dose of 125 or 250 mcg/m2/day by either the intravenous (IV) or subcutaneous (SQ) route. The goal of the study is to establish the dose and route of delivery that results in resolution of immunoparalysis (TNF-alpha response \>=200 pg/ml) by the morning after the 3rd scheduled dose with persistent resolution of immunoparalysis on the morning after the 7th scheduled dose. Resolution of immunoparalysis in 8 out of the first 10 subjects in a study treatment arm represents a successful dose and route. The goal of this study will be achieved through the following Specific Aims: Specific Aim 1. Establish the immunologic efficacy of GM-CSF administered by the IV and SQ routes in children with immunoparalysis in the setting of sepsis-induced MODS. Specific Aim 2. Estimate the pharmacokinetic parameters by the IV and SQ GM-CSF administered in pediatric sepsis-induced MODS. Specific Aim 3. Demonstrate the feasibility of screening, enrollment, drug delivery, and sample collection for a multi-center immunostimulation trial in children with sepsis-induced MODS.
Primary Outcome
Success in a cohort is defined as improvement in the whole blood ex vivo LPS-induced TNF-alpha production capacity (TNF response) to \>= 200 pg/ml by the morning after the 3rd dose and persisting to the morning after the 7th dose in at least 8 out of 10 treated subjects within a cohort
Conditions Studied
Interventions
- DRUG GM-CSF
Study Locations (8)
California
- UCLA Mattel Children's Hospital - Los Angeles
- Benioff Children's Hospital/UCSF - San Francisco
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh - Pittsburgh
Colorado
- Children's Hospital of Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Michigan
- Children's Hospital of Michigan - Detroit
Ohio
- Nationwide Children's Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2018-12-05 |
| Est. Completion | 2023-12-05 |
| Phase | Phase 4 |
What the registry record for NCT03769844 still lists
NCT03769844 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Pediatric Sepsis-induced MODS appearing as the primary indexed condition, and to 1 intervention - of which GM-CSF is the first listed.
NCT03769844 lists 8 locations in 6 states (California, Pennsylvania, Colorado).
Frequently Asked Questions
What is clinical trial NCT03769844 about?
NCT03769844 is a clinical study titled "GM-CSF for Reversal of immunopAralysis in pediatriC sEpsis-induced MODS Study". This study is an open-label, multi-center, interventional trial in which children with sepsis-induced MODS undergo surveillance immune function testing beginning on Day 2 of MODS. Those children who demonstrate immunoparalysis (TNF-alpha response \<200 pg/ml) will receive a 7-day course of GM-CSF at...
What is the current status of trial NCT03769844?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2018-12-05. Estimated completion is 2023-12-05.
What conditions does trial NCT03769844 study?
This clinical trial studies the following conditions: Pediatric Sepsis-induced MODS.
What interventions are being tested in trial NCT03769844?
The interventions under investigation include: GM-CSF (DRUG).
Who is sponsoring clinical trial NCT03769844?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03769844 being conducted?
This trial has 8 study locations across California, Colorado, District of Columbia, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03769844's enrollment target sits among peer trials
120 673rd of 2000 higher than 1,290 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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