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GM-CSF for Reversal of immunopAralysis in pediatriC sEpsis-induced MODS Study
NCT03769844 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03769844
The ClinicalTrials.gov registry entry for NCT03769844 describes a study currently listed as active not recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 239 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03769844 reports 8 study locations spanning 6 distinct geographic areas — top geographies include California, Pennsylvania, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03769844?
The interventions under investigation include: GM-CSF (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03769844?
This trial is sponsored by Nationwide Children's Hospital, which has 239 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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