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A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS (CARPO)

Primary Purpose

Acute Pancreatitis, Systemic Inflammatory Response Syndrome

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CM-4620 Injectable Emulsion or CM-4620-IE
Placebo
Sponsored by
CalciMedica, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All of the following must be met for a patient to be randomized into the study:

  1. The diagnosis of acute pancreatitis has been established by the presence of abdominal pain consistent with acute pancreatitis together with at least 1 of the following 2 criteria:

    1. Serum lipase > 3 times the upper limit of normal (ULN);
    2. Characteristic findings of acute pancreatitis on abdominal imaging;
  2. The diagnosis of SIRS has been established by the presence of at least two of the following four criteria:

    1. Temperature < 36°C or > 38°C;
    2. Heart rate > 90 beats/minute;
    3. Respiratory rate >20 breaths/minute or arterial carbon dioxide tension (PaCO2) <32 mmHg;
    4. White blood cell count (WBC) >12,000 mm3, or <4,000 mm3, or > 10% immature (band) forms;
  3. At least one of the following criteria is also present:

    1. A peripancreatic fluid collection or a pleural effusion on a contrast-enhanced computed tomography (CECT) performed in the 24 hours before Consent or after Consent and before Randomization;
    2. Abdominal examination documenting either abdominal guarding or rebound tenderness;
    3. Hematocrit ≥44% for men or ≥40% for women;
  4. The patient is ≥ 18 years of age;
  5. Lack of pancreatic necrosis, pancreatic calcifications, pancreatic pseudocysts and no evidence for previous necrosectomy or pancreatic surgery identified by CECT performed in the 24 hours before Consent or after Consent and before Randomization;
  6. A female patient of childbearing potential who is sexually active with a male partner is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. A female patient must not attempt to become pregnant for 180 days;
  7. A male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. A male patient must not donate sperm for 180 days;
  8. The patient is willing and able to, or has a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.

Exclusion Criteria:

Patients with any of the following conditions or characteristics must be excluded from randomizing:

  1. Expected survival <6 months;
  2. Suspected presence of cholangitis in the judgment of the treating physician;
  3. The patient has a known history of:

    1. Organ or hematologic transplant;
    2. HIV, hepatitis B, or hepatitis C infection;
    3. Chronic pancreatitis;
  4. Current treatment with:

    1. Chemotherapy;
    2. Immunosuppressive medications or immunotherapy
    3. Pancreatic enzyme replacement therapy;
    4. Hemodialysis or Peritoneal Dialysis;
  5. The patient is known to be pregnant or is nursing;
  6. The patient has participated in another study of an investigational drug or therapeutic medical device in the 30 days before randomization;
  7. Allergy to eggs or known hypersensitivity to any components of study drug.

Sites / Locations

  • University of ArkansasRecruiting
  • Long Beach Medical CenterRecruiting
  • Kaiser Permanente Los Angeles Medical Center
  • LA County Hospital - USCRecruiting
  • Cedars Sinai
  • UCLA Ronald Reagan Medical CenterRecruiting
  • University of California at Irvine Medical CenterRecruiting
  • Harbor UCLA Medical CenterRecruiting
  • Torrance Memorial Medical CenterRecruiting
  • National Jewish Health
  • Yale University School of Medicine
  • The Stamford Hospital
  • Sarasota Memorial Health Care SystemRecruiting
  • Tampa General HospitalRecruiting
  • St. Luke's Regional Medical CenterRecruiting
  • Northwestern University HospitalRecruiting
  • Robley Rex VA Medical CenterRecruiting
  • Lumunis Health Anne Arundel Medical Center
  • University of MarylandRecruiting
  • Henry Ford Health SystemRecruiting
  • Methodist HospitalRecruiting
  • Regions HospitalRecruiting
  • University of Missouri School of MedicineRecruiting
  • Washington University School of Medicine
  • Northshore University HospitalRecruiting
  • Long Island Jewish Hospital
  • Icahn School of Medicine at Mount SinaiRecruiting
  • Ohio State UniversityRecruiting
  • Regional One HealthRecruiting
  • John Peter Smith HospitalRecruiting
  • Houston Methodist HospitalRecruiting
  • UT Health HoustonRecruiting
  • University Health System at San Antonio
  • University of VirginiaRecruiting
  • Virginia Commonwealth University
  • CAMC Institute for Academic MedicineRecruiting
  • Lisie HospitalRecruiting
  • Vijaya Super Speciality HospitalRecruiting
  • MTES' Sanjeevan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

2.0 mg/kg (1.25 mL/kg)

1.0 mg/kg (0.625 mL/kg)

0.5 mg/kg (0.3125 mL/kg)

Placebo (1.25, 0.625, or 0.3125 mL/kg)

Arm Description

administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.

administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.

administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.

patients randomized to placebo will receive one of three following volumes (1.25 mL/kg, 0.625 mL/kg, and 0.3125 mL/kg. although three volumes - all patients randomized to placebo will be analyzed together as one arm. administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.

Outcomes

Primary Outcome Measures

Time to solid food tolerance
Defined as the number of hours from the date and time of the start of the first infusion of study (SFISD) for the patient to the date and time the patient receives a solid meal that is tolerated

Secondary Outcome Measures

Solid food tolerance
Time to medically indicated discharge
Length of stay in the hospital
Length of stay in the ICU for patients admitted to the ICU
Re-hospitalization for acute pancreatitis by Day 30
Change in severity of acute pancreatitis by CTSI score from screening to Day 30
Development of pancreatic necrosis ≥30% and >50%
The persistence of SIRS ≥48 hours after the SFISD
Incidence, severity, and duration of organ failure
Mortality by Day 30
Change in pain score
Change in opioid use

Full Information

First Posted
December 15, 2020
Last Updated
October 24, 2023
Sponsor
CalciMedica, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04681066
Brief Title
A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS
Acronym
CARPO
Official Title
A Randomized, Double-Blind, Placebo Controlled Dose-Ranging Study of Auxora in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CalciMedica, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Approximately 216 patients with acute pancreatitis and accompanying SIRS will be randomized at approximately 30 sites. Patients will be randomly assigned to either Auxora at one of three dose levels or one of three placebo volumes to maintain the double-blind. Study drug infusions will occur every 24 hours for three consecutive days for a total of three infusions. Patients will remain hospitalized as per standard of care and once discharged will be asked to complete a daily meal diary and return for a Day 30 safety assessment. It is recommended that patients randomized in the study should not be discharged from the hospital until solid food is tolerated, abdominal pain has resolved or been adequately controlled, and there is no clinical evidence of infection necessitating continued hospitalization.
Detailed Description
This double blind, randomized, placebo-controlled study will evaluate the efficacy, safety, and tolerability of three different dose levels of Auxora in patients with acute pancreatitis and accompanying SIRS. Approximately 216 patients will be randomized 1:1:1:1 into one of 4 groups using a computer generated randomization scheme accessed through an interactive voice/web response system (IXRS). Randomization will be first stratified by gender (male or female) and then by risk for organ failure in the gender subgroups (higher or lower). Higher risk for organ failure is defined by the presence of both an elevated hematocrit (HCT ≥44% for men or ≥40% for women) and hypoxemia (imputed PaO2/FiO2 ≤360). Lower risk for organ failure is defined by the absence of either or both an elevated hematocrit and hypoxemia. The PaO2/FiO2 will be determined using an arterial blood gas or imputed using pulse oximetry. All patients will have received a Screening CECT of the abdomen/pancreas before being randomized into the study. CECTs performed as standard of care may be used as the Screening CECT but must have been performed in the 24 hours before Consent or after Consent and before Randomization. The Start of First Infusion of Study Drug (SFISD) should occur within 8 hours of the patient or LAR providing informed consent. Patients randomized to Group 1 will receive 2.0 mg/kg of Auxora intravenously every 24 hours (±1 hour) for a total of three doses. Patients randomized to Group 2 will receive 1.0 mg/kg of Auxora intravenously every 24 hours (±1 hour) for a total of three doses. Patients randomized to Group 3 will receive 0.5 mg/kg of Auxora intravenously every 24 hours (±1 hour) for a total of three doses. Patients randomized to Group 4 will receive emulsion without any active pharmaceutical ingredient. Patients in Group 4 will receive one of three randomly assigned dose volumes, 1.25 mL/kg, 0.625 mL/kg, or 0.3125 mL/kg, which will be administered intravenously every 24 hours (±1 hour) for a total of three doses. The dosing will be based on actual body weight obtained at the time of hospitalization or screening for the study. As described in the pharmacy manual, the upper limit of the volume of Auxora and volume of Placebo that will be administered will be 156.25 mL. The sponsor, investigators and patients will be blinded to the assigned group. In the event of a medical emergency, investigators will be able to receive the treatment assignment if required to provide optimal care of the patient. For all 4 groups, a study physician or appropriately trained delegate will perform assessments at screening, at the baseline assessment, immediately prior to the SFISD, and then every 24 hours until 240 hours after the SFISD, or until discharge if earlier. If patients remain hospitalized at Day 12, assessments will then be performed every 48 hours starting on Day 12 until Day 28, or until discharge if earlier. Patients discharged from the hospital before Day 25 will return at Day 30 (+5 days) to perform the Day 30 assessments. If patients are discharged on Days 25-29, the Day 30 assessments may be performed prior to discharge. Patients will receive another CECT of the abdomen/pancreas at the Day 30 (±5 days) visit. All CECTs performed as standard of care after randomization and before the Day 30 CECT will also be captured. A blinded central reader will read the Screening, Day 30, and any standard of care CECTs obtained between randomization and the Day 30 visit. Patients will complete the modified American Neurogastroenterology and Motility Society Gastrointestinal Cardinal Symptom Index Daily Diary (mGCSI-DD) worksheet at the baseline assessment, at 96 hours, 168hours, Day 14 and Day 21 (for patients who remain hospitalized on these days), on the day of discharge, and daily at bedtime after discharge until the Day 30 visit. Patients who are discharged on Days 25-29 will not complete the mGCSI worksheet after discharge. It is recommended that all patients randomized in the study should receive care consistent with the 2018 American Gastroenterological Association (AGA) Institute Technical Review of the Initial Medical Management of Acute Pancreatitis. Patients should receive local standard of care (SOC) for the management of other medical conditions. In patients with acute pancreatitis, the AGA strongly recommends early oral feeding (within 24 hours) rather than keeping the patient nil per mouth (Nil per Os, NPO). Patients randomized into the study, therefore, will be offered a low fat, ≥500-calorie solid meal at each mealtime after the infusion of the first dose of study drug if alert and not on mechanical ventilation, or if not NPO for a planned surgey/medical procedure, or if not NPO because of an acute medical condition. If the patient does not wish to eat the solid meal when offered or is unable to tolerate the solid meal, they should then be offered a liquid meal. The same approach should occur at each subsequent mealtime. When patients eat a solid meal, it should be recorded if they ate ≥50% of the meal and if they either vomited or experienced an increase in abdominal pain in the two hours after eating a meal. It is also recommended that all patients randomized in the study should not be discharged from the hospital until solid food is tolerated, abdominal pain has resolved or been adequately controlled, and there is no clinical evidence of infection. Tolerating solid food is defined as eating ≥50% of a low fat, ≥500-calorie solid meal without an increase in abdominal pain or vomiting. If the patient is not tolerating either solid or liquid meals, tube feedings should be considered. All protocol required laboratory testing, except biomarker and PK samples, will be performed at the local laboratory. Results from the biomarkers and PK blood samples collected as part of the protocol and being tested at a central lab will not be available to assist the PI or treating physician in managing the patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis, Systemic Inflammatory Response Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Matching placebo
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2.0 mg/kg (1.25 mL/kg)
Arm Type
Active Comparator
Arm Description
administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.
Arm Title
1.0 mg/kg (0.625 mL/kg)
Arm Type
Active Comparator
Arm Description
administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.
Arm Title
0.5 mg/kg (0.3125 mL/kg)
Arm Type
Active Comparator
Arm Description
administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.
Arm Title
Placebo (1.25, 0.625, or 0.3125 mL/kg)
Arm Type
Placebo Comparator
Arm Description
patients randomized to placebo will receive one of three following volumes (1.25 mL/kg, 0.625 mL/kg, and 0.3125 mL/kg. although three volumes - all patients randomized to placebo will be analyzed together as one arm. administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.
Intervention Type
Drug
Intervention Name(s)
CM-4620 Injectable Emulsion or CM-4620-IE
Other Intervention Name(s)
Auxora
Intervention Description
Auxora is to be administered as an IV infusion and is supplied as a translucent, white to yellowish colored, sterile, non-pyrogenic emulsion containing 1.6 mg/mL of the active pharmaceutical ingredient CM4620. CM4620-IE is supplied as an 80 mL fill in a 100 mL, single-use glass vial. The drug product is formulated as an emulsion due to the low solubility of CM4620 in aqueous solution. CM4620-IE contains egg phospholipids, medium chain triglycerides, glycerin, edetate disodium salt dehydrate (EDTA), sodium hydroxide (as needed to adjust pH), and sterile water for injection.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo is to be administered as an IV infusion and is supplied as a translucent, white to yellowish, sterile, non-pyrogenic emulsion carrier containing no active pharmaceutical ingredient. Placebo is supplied as an 80 mL fill in a 100 mL single-use vial. Placebo contains the same ingredients as Auxora except that it does not contain CM4620.
Primary Outcome Measure Information:
Title
Time to solid food tolerance
Description
Defined as the number of hours from the date and time of the start of the first infusion of study (SFISD) for the patient to the date and time the patient receives a solid meal that is tolerated
Time Frame
from start of first infusion of study drug (SFISD) to day 30
Secondary Outcome Measure Information:
Title
Solid food tolerance
Time Frame
from SFISD to 48 hours, 72 hours and 96 hours and at time of hospital discharge
Title
Time to medically indicated discharge
Time Frame
from start of first infusion of study drug and through time of hospital discharge or through Day 30, whichever occurs first
Title
Length of stay in the hospital
Time Frame
from admission date into the hospital until discharge date from the hospital
Title
Length of stay in the ICU for patients admitted to the ICU
Time Frame
from admission into ICU until discharge from ICU
Title
Re-hospitalization for acute pancreatitis by Day 30
Time Frame
time from initial date of hospital discharge through date of re-hospitalization through day 30
Title
Change in severity of acute pancreatitis by CTSI score from screening to Day 30
Time Frame
from informed consent through day 30
Title
Development of pancreatic necrosis ≥30% and >50%
Time Frame
from enrollment CECT through Day 30 CECT
Title
The persistence of SIRS ≥48 hours after the SFISD
Time Frame
from SFISD through day 30
Title
Incidence, severity, and duration of organ failure
Time Frame
from enrollment and through day 30
Title
Mortality by Day 30
Time Frame
from randomization and through day 30
Title
Change in pain score
Time Frame
from enrollment through day 30
Title
Change in opioid use
Time Frame
from enrollment through day 30
Other Pre-specified Outcome Measures:
Title
Development of infected pancreatic necrosis
Description
Exploratory
Time Frame
from enrollment CECT through Day 30 CECT
Title
Development of sepsis
Description
Exploratory
Time Frame
from randomization through day 30
Title
Hospital procedures for the management of pancreatic necrosis
Description
Exploratory
Time Frame
from randomization through day 30
Title
Change in GCSI-DD score
Description
Exploratory
Time Frame
from randomization through day 30
Title
Change in albumin
Description
Exploratory
Time Frame
from randomization through day 30
Title
Change in ANC/ALC ratio and IL-6 levels
Description
Exploratory
Time Frame
from randomization through day 30
Title
Change in urine NGAL
Description
Exploratory
Time Frame
from randomization through day 30

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
self-reported gender
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All of the following must be met for a patient to be randomized into the study: The diagnosis of acute pancreatitis has been established by the presence of abdominal pain consistent with acute pancreatitis together with at least 1 of the following 2 criteria: Serum lipase > 3 times the upper limit of normal (ULN); Characteristic findings of acute pancreatitis on abdominal imaging; The diagnosis of SIRS has been established by the presence of at least two of the following four criteria: Temperature < 36°C or > 38°C; Heart rate > 90 beats/minute; Respiratory rate >20 breaths/minute or arterial carbon dioxide tension (PaCO2) <32 mmHg; White blood cell count (WBC) >12,000 mm3, or <4,000 mm3, or > 10% immature (band) forms; At least one of the following criteria is also present: A peripancreatic fluid collection or a pleural effusion on a contrast-enhanced computed tomography (CECT) performed in the 24 hours before Consent or after Consent and before Randomization; Abdominal examination documenting either abdominal guarding or rebound tenderness; Hematocrit ≥44% for men or ≥40% for women; The patient is ≥ 18 years of age; Lack of pancreatic necrosis, pancreatic calcifications, pancreatic pseudocysts and no evidence for previous necrosectomy or pancreatic surgery identified by CECT performed in the 24 hours before Consent or after Consent and before Randomization; A female patient of childbearing potential who is sexually active with a male partner is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. A female patient must not attempt to become pregnant for 180 days; A male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. A male patient must not donate sperm for 180 days; The patient is willing and able to, or has a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol. Exclusion Criteria: Patients with any of the following conditions or characteristics must be excluded from randomizing: Expected survival <6 months; Suspected presence of cholangitis in the judgment of the treating physician; The patient has a known history of: Organ or hematologic transplant; HIV, hepatitis B, or hepatitis C infection; Chronic pancreatitis; Current treatment with: Chemotherapy; Immunosuppressive medications or immunotherapy Pancreatic enzyme replacement therapy; Hemodialysis or Peritoneal Dialysis; The patient is known to be pregnant or is nursing; The patient has participated in another study of an investigational drug or therapeutic medical device in the 30 days before randomization; Allergy to eggs or known hypersensitivity to any components of study drug.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liisa Tingue
Phone
9725231073
Email
liisa@calcimedica.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudarshan Hebbar, MD
Organizational Affiliation
CalciMedica, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sumant Inamdar, MD, PhD
Email
SInamdar@uams.edu
First Name & Middle Initial & Last Name & Degree
Sumant Inamdar, MD, PhD
Facility Name
Long Beach Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis Suarez
Phone
562-760-7221
Email
ASuarez2@memorialcare.org
First Name & Middle Initial & Last Name & Degree
Fady Youssef, MD
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Withdrawn
Facility Name
LA County Hospital - USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro Vazquez
Email
Alejandro.Vazquez@med.usc.edu
First Name & Middle Initial & Last Name & Degree
James Buxbaum, MD
Facility Name
Cedars Sinai
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bonnie Paul
Phone
424-279-3374
Email
bonnie.paul@cshs.org
First Name & Middle Initial & Last Name & Degree
Stephen Pandol, MD
Facility Name
UCLA Ronald Reagan Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Arevalo
Email
MFArevalo@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Edward Livingston, MD
Facility Name
University of California at Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cesar Figueroa
Phone
714-509-2487
Email
figuercl@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Jason Samarasena, MD
Facility Name
Harbor UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dyonne Tetangco
Phone
424-571-7635
Email
d.tetangco@lundquist.org
First Name & Middle Initial & Last Name & Degree
Brant Putnam, MD
Facility Name
Torrance Memorial Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joy Gonzalez
Email
HernaJoy.Gonzalez@tmmc.com
First Name & Middle Initial & Last Name & Degree
James McKinnell, MD
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Individual Site Status
Withdrawn
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Withdrawn
Facility Name
The Stamford Hospital
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Individual Site Status
Completed
Facility Name
Sarasota Memorial Health Care System
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamela Fonseca, MSN, RN
Phone
941-228-1752
Email
Tamela-Fonseca@smh.com
First Name & Middle Initial & Last Name & Degree
Ibrahim Saad, MD
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Barnes, BSN, RN
Phone
813-660-6035
Email
ashleynbarnes@tgh.org
First Name & Middle Initial & Last Name & Degree
Jason Wilson, MD
Facility Name
St. Luke's Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Summer Reames, MPH
Phone
208-381-8907
Email
reamess@slhs.org
First Name & Middle Initial & Last Name & Degree
Karen Miller, MD
Facility Name
Northwestern University Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Li
Phone
312-472-9597
Email
thomasli@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Raj Keswani, MD
Facility Name
Robley Rex VA Medical Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Marie Webb
Email
anne.webb@louisville.gov
First Name & Middle Initial & Last Name & Degree
Gerald Dryden, MD
Facility Name
Lumunis Health Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyra Lasko
Email
Kyra.lasko@som.umaryland.edu
First Name & Middle Initial & Last Name & Degree
R. Gentry Wilkerson, MD
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Wilson
Phone
313-916-9551
Email
kwilso10@hfhs.org
First Name & Middle Initial & Last Name & Degree
Joseph Miller, MD
Facility Name
Methodist Hospital
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wiktoria Patek
Email
Wiktoria.X.Pasek@HealthPartners.Com
First Name & Middle Initial & Last Name & Degree
Michael Schnaus, MD
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wiktoria Patek
Email
Wiktoria.X.Pasek@HealthPartners.Com
First Name & Middle Initial & Last Name & Degree
Charles Bruen, MD
Facility Name
University of Missouri School of Medicine
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mihiri DeSilva
Email
desilvam@health.missouri.edu
First Name & Middle Initial & Last Name & Degree
Syed Naqvi, MD
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Completed
Facility Name
Northshore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Keating
Email
mkeating1@northwell.edu
First Name & Middle Initial & Last Name & Degree
Daniel Rolston, MD
Facility Name
Long Island Jewish Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Withdrawn
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitali Ashokkumar Pradhan, MS
Phone
201-423-3585
Email
Mitali.Pradhan@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Jonathan Schimmel, MD
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bryan Chu
Phone
614-668-6223
Email
ChingMin.Chu@osumc.edu
First Name & Middle Initial & Last Name & Degree
Jason Bischof
Facility Name
Regional One Health
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Barbee, BSN, RN
Email
kgbarbee@regionalonehealth.org
First Name & Middle Initial & Last Name & Degree
Amber Thacker, MD
Facility Name
John Peter Smith Hospital
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay Crutcher, RN, BSN
Phone
817-702-6746
Email
LCrutche01@jpshealth.org
First Name & Middle Initial & Last Name & Degree
April Bell
Email
abell01@jpshealth.org
First Name & Middle Initial & Last Name & Degree
James D'Etienne, MD
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anisha Gupte, PhD
Email
AAGUPTE@houstonmethodist.org
First Name & Middle Initial & Last Name & Degree
Raul Sanchez Leon, MD
Facility Name
UT Health Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neomi Sepulveda
Email
Neomi.Sepulveda@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
David Robinson, MD
Facility Name
University Health System at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Simpson
Phone
434-924-2897
Email
mailto:APS2H@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Thomas Hartka, MD
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Withdrawn
Facility Name
CAMC Institute for Academic Medicine
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Marberry, MSW
Phone
304-388-9957
Email
morgan.marberry@camc.org
First Name & Middle Initial & Last Name & Degree
Harleen Chela, MD
Facility Name
Lisie Hospital
City
Kochi
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ms. Lincy
Email
lincympalatty@gmail.com
First Name & Middle Initial & Last Name & Degree
Mathew Philip, MD
Facility Name
Vijaya Super Speciality Hospital
City
Nellore
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gayazuddin Shaik
Email
projectspcr@gmail.com
First Name & Middle Initial & Last Name & Degree
M.V. Rama Mohan, MD
Facility Name
MTES' Sanjeevan Hospital
City
Pune
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Umesh Dumbre
Email
dr.dumbreumesh@gmail.com
First Name & Middle Initial & Last Name & Degree
Bahar Kulkarani, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS

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