Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)Phase 2/3TRIPSNCT05267821
Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS
A Phase 2/3 study testing Anakinra in people with Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS), run by Nationwide Children's Hospital at 32 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)
- What is being tested?
- Anakinra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 32 sitesUnited States
- Study dates
- 14 Jun 2022to 31 Aug 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≥ 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.
Who cannot join
- 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
- Current or prior diagnosis of hemophagocytic lymphohistiocytosis or macrophage activation syndrome; OR
- Peripheral white blood cell count < 1,000 cells/mm3 as the result of myeloablative therapy OR receipt of myeloablative therapy within the previous 14 days; OR
Show all 12Show fewer
- Known allergy to anakinra, or E. coli-derived products; OR
- Known pregnancy; OR
- Lactating females; OR
- Receipt of anakinra within the previous 28 days; OR
- Resolution of MODS by MODS Day 2; OR
- Previous enrollment in the TRIPS study.
Trial locations and contacts
32 sites in 1 country. Contact the study team or a site near you to ask about taking part.
32 sites in 1 country
United States32 sites, 32 recruiting
- Recruiting
Akron Children's Hospital
Akron, Ohio, 44308
Christopher Page-Goertz, MD, CPage-Goertz@akronchildrens.org
- Recruiting
CS Mott Children's Hospital
Ann Arbor, Michigan, 48109
Michael Quasney
- Recruiting
Children's Hospital of Atlanta
Atlanta, Georgia, 30329
Jocelyn Grunwell, MD, PhD, jocelyn.grunwell@emory.edu
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Eva Nozik
- Recruiting
Children's of Alabama
Birmingham, Alabama, 35233
Michele Kong, MD, mkong@uabmc.edu
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
John Costello, costello@musc.edu
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Natalja Stanski, MD, 513-636-4200, natalja.stanski@cchmc.org
- Recruiting
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Kenneth Remy, kenneth.remy@uhhospitals.org
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Mark Hall, 614-722-3438, mark.hall@nationwidechildrens.org
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
Matthew Borgman, 214-648-3111, Matthew.Borgman@UTSouthwestern.edu
- Recruiting
Children's Hospital of Michigan
Detroit, Michigan, 48201
Kathleen Meert, MD, 313-745-5437
- Recruiting
Duke University
Durham, North Carolina, 27705
Christoph Hornik
- Recruiting
Pennsylvania State University
Hershey, Pennsylvania, 17033
Neal Thomas
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Ayse Arikan
- Recruiting
Riley Children's Hospital
Indianapolis, Indiana, 46204
Daniel Cater, MD, 317-944-5000, dancater@iu.edu
- Recruiting
Mercy Children's Hospital
Kansas City, Missouri, 64108
Yong Han
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Ronald Sanders
- Recruiting
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Robinder Khemani
- Not yet recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53233
Nathan Thompson
- Not yet recruiting
Children's Hospital of Minnesota
Minneapolis, Minnesota, 55404
Alberto Orioles
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Marie Steiner
- Recruiting
Benioff Children's Hospital - Oakland
Oakland, California, 64609
Natalie Cvijanovich
- Not yet recruiting
Children's Hospital of Orange County
Orange, California, 92868
Adam Schwarz
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Julie Fitzgerald, fitzgeraldj@chop.edu
- Recruiting
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Joseph Carcillo, carcilloja@ccm.upmc.edu
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Nikki Miller-Ferguson
- Recruiting
University of California, Davis
Sacramento, California, 95817
MoonJoo Han, MD, 800-282-3284, mjohan@ucdavis.edu
- Recruiting
Primary Children's Hospital
Salt Lake City, Utah, 84158
Jill Sweney
- Recruiting
Children's Hospital of San Antonio
San Antonio, Texas, 78207
Kirstin Henley, kirstin.henley@christushealth.org
- Recruiting
Rady Children's Hospital
San Diego, California, 92123
Nicole Coufal, 858-976-5900, ncoufal@health.ucsd.edu
- Recruiting
Benioff Children's Hospital - Mission Bay
San Francisco, California, 94143
Patrick McQuillen
- Recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Sonali Basu, 888-884-2327, sbasu@childrensnational.org
About this study
Official title: Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS)
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).
Read the detailed description
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). Eligible subjects will undergo centralized immunophenotyping on day 2 of MODS. Subjects without immunoparalysis (a whole blood ex vivo LPS-induced TNF-alpha production capacity < 200 pg/ml) and a serum ferritin level of 500 - 2,000 ng/ml or a serum C-reactive protein (CRP) ≥ 4 mg/dl will be eligible for randomization, along with subjects with a serum ferritin level of 2,000 - 10,000 ng/ml regardless of their TNF-alpha response. Eligible subjects will receive intravenous (IV) anakinra at a dose of 4, 8, 12, or 16 mg/kg/day or placebo for 7 days.
- Being tested
- Anakinra, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
See information in arm/group descriptions
PlaceboDrug
See information in arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Anakinra 4 mg/kg/day | Active comparator | IV Anakinra 4mg/kg/day x 7 days Receives: Drug: Anakinra |
| Anakinra 8 mg/kg/day | Active comparator | IV Anakinra 8 mg/kg/day x 7 days Receives: Drug: Anakinra |
| Anakinra 12 mg/kg/day | Active comparator | IV Anakinra 12 mg/kg/day x 7 days Receives: Drug: Anakinra |
| Anakinra 16 mg/kg/day | Active comparator | IV Anakinra 16 mg/kg/day x 7 days Receives: Drug: Anakinra |
| Placebo | Placebo comparator | IV placebo x 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days from randomization
Secondary outcomes (2)
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.
Measured: 3 months post-randomization
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.
Measured: 3 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start14 Jun 2022
- Primary completion15 May 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)Studies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, adaptively-randomized, double-blind, placebo controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Mark Hall, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267821
- Sponsor's protocol ID
- TRIPS
- Acronym
- TRIPS
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2022
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 37498156
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS)
- ClinicalTrials.gov ID
- NCT05267821
- Acronym / sponsor ID
- TRIPS / TRIPS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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). Eligible subjects will undergo centralized immunophenotyping on day 2 of MODS. Subjects without immunoparalysis (a whole blood ex vivo LPS-induced TNF-alpha production capacity < 200 pg/ml) and a serum ferritin level of 500 - 2,000 ng/ml or a serum C-reactive protein (CRP) ≥ 4 mg/dl will be eligible for randomization, along with subjects with a serum ferritin level of 2,000 - 10,000 ng/ml regardless of their TNF-alpha response. Eligible subjects will receive intravenous (IV) anakinra at a dose of 4, 8, 12, or 16 mg/kg/day or placebo for 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Prospective, adaptively-randomized, double-blind, placebo controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Anakinra 4 mg/kg/day | Active comparator | Drug: AnakinraIV Anakinra 4mg/kg/day x 7 days |
| Anakinra 8 mg/kg/day | Active comparator | Drug: AnakinraIV Anakinra 8 mg/kg/day x 7 days |
| Anakinra 12 mg/kg/day | Active comparator | Drug: AnakinraIV Anakinra 12 mg/kg/day x 7 days |
| Anakinra 16 mg/kg/day | Active comparator | Drug: AnakinraIV Anakinra 16 mg/kg/day x 7 days |
| Placebo | Placebo comparator | Drug: PlaceboIV placebo x 7 days |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ≥ 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.
Key exclusion criteria (12 listed)
- 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
- Current or prior diagnosis of hemophagocytic lymphohistiocytosis or macrophage activation syndrome; OR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnakinraSee information in arm/group descriptions | Drug | Anakinra 12 mg/kg/day, Anakinra 16 mg/kg/day, Anakinra 4 mg/kg/day, Anakinra 8 mg/kg/day |
| PlaceboSee information in arm/group descriptions | Drug | Placebo |
Primary outcome
Cumulative 28-day Pediatric Logistic Organ Dysfunction (PELOD-2) score
Time frame: 28 days from randomization
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.
2 secondary outcomes
3-month health-related quality of life
Time frame: 3 months post-randomization
3-month functional status
Time frame: 3 months post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Derived from this study: PubMed 37498156VanBuren 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Anakinra in people with Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS), run by Nationwide Children's Hospital at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Hall, MD (6147223438, mark.hall@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative 28-day Pediatric Logistic Organ Dysfunction (PELOD-2) score (time frame: 28 days from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05267821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.