NCT02897206

Brief Summary

This is a prospective, single-center, randomized, placebo-controlled, double-blind clinical trial that aims to investigate the beneficial and harmful effects of prophylactic use of imipenem in patients with predicted severe acute pancreatitis. All patients with first attack of acute pancreatitis, an onset of disease less than 72h before admission, and an APACHE II score ≥ 8 calculated within the first 24h from admission will be enrolled.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2015

Completed
9 months until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

2.2 years

First QC Date

December 20, 2015

Last Update Submit

June 18, 2017

Conditions

Acute Pancreatitis

Keywords

Acute pancreatitisAntibiotic prophylaxisImipenem-cilastatinInfected pancreatic necrosisInfectionOrgan failure

Outcome Measures

Primary Outcomes (1)

  • Infectious complications

    30 days

Secondary Outcomes (7)

  • Mortality

    30 days

  • Number of patients with Systemic Inflammatory Response Syndrome (SIRS)

    30 days

  • Local complications

    30 days

  • Systemic complications

    30 days

  • Number of patients with persistent and transitory organ failure (cardiovascular, respiratory, renal)

    30 days

  • +2 more secondary outcomes

Study Arms (2)

Imipenem group

EXPERIMENTAL

Imipenem 3 x 500 mg i.v. daily ideally for 10 days (minimum 7 days, maximum 21 days)

Drug: Imipenem

Placebo group

PLACEBO COMPARATOR

Identical placebo administered in identical dosage, timing and duration.

Drug: Placebo

Interventions

ImipenemDRUG

A wide-spectre antibiotic from the carbapenem group

Also known as: Imipenem-cilastatin
Imipenem group
PlaceboDRUG

An imipenem-matching placebo

Placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of acute pancreatitis defined by the Revised 2012 Atlanta Criteria
  • first manifestation of acute pancreatitis regardless of etiology
  • APACHE II ≥ 8 calculated within the first 24 hours of admission
  • onset of symptoms \< 72 hours before admission

You may not qualify if:

  • age \< 18 years
  • pregnant and breastfeeding women
  • active and documented infection at admission
  • concomitant antibiotic treatment or antibiotic treatment present within 72 hours before enrollment
  • acute pancreatitis diagnosed at surgery
  • active malignancy
  • known immune deficiency
  • patients with chronic pancreatitis
  • patients unwilling to participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Rijeka

Rijeka, 51000, Croatia

Location

Related Publications (1)

  • Poropat G, Radovan A, Peric M, Mikolasevic I, Giljaca V, Hauser G, Milic S, Stimac D. Prevention of Infectious Complications in Acute Pancreatitis: Results of a Single-Center, Randomized, Controlled Trial. Pancreas. 2019 Sep;48(8):1056-1060. doi: 10.1097/MPA.0000000000001368.

    PMID: 31404018DERIVED

MeSH Terms

Conditions

PancreatitisInfections

Interventions

ImipenemCilastatin, Imipenem Drug Combination

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ThienamycinsCarbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCilastatinCyclopropanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipidsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Davor Stimac, MD, PhD

    Department of Gastroenterology, University Hospital Rijeka

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Researcher

Study Record Dates

First Submitted

December 20, 2015

First Posted

September 13, 2016

Study Start

October 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 20, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)