Imipenem Prophylaxis in Patients With Acute Pancreatitis

NCT ID: NCT02897206

Last Updated: 2017-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-12-31

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.

Conditions

Acute Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Imipenem group

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

Group Type: EXPERIMENTAL

Imipenem

Intervention Type: DRUG

A wide-spectre antibiotic from the carbapenem group

Placebo group

Identical placebo administered in identical dosage, timing and duration.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

An imipenem-matching placebo

Interventions

Imipenem

A wide-spectre antibiotic from the carbapenem group

Intervention Type: DRUG

Placebo

An imipenem-matching placebo

Intervention Type: DRUG

Other Intervention Names

Imipenem-cilastatin

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rijeka

OTHER

Sponsor Role: collaborator

University Hospital Rijeka

OTHER

Sponsor Role: lead

Responsible Party

Goran Poropat

Postdoctoral Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Davor Stimac, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, University Hospital Rijeka

Locations

University Hospital Rijeka

Rijeka, , Croatia

Countries

Croatia

References

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.

Reference Type: DERIVED

PMID: 31404018 (View on PubMed)

Other Identifiers

13.06.1.2.30

Identifier Type: -

Identifier Source: org_study_id