Imipenem Prophylaxis in Patients With Acute Pancreatitis
NCT02897206 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 98
Last updated 2017-06-20
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
Interventions
- DRUG
-
Imipenem
A wide-spectre antibiotic from the carbapenem group
- DRUG
-
An imipenem-matching placebo
Sponsors & Collaborators
-
University of Rijeka
collaborator OTHER -
University Hospital Rijeka
lead OTHER
Principal Investigators
-
Davor Stimac, MD, PhD · Department of Gastroenterology, University Hospital Rijeka
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-10-31
- Primary Completion
- 2016-12-31
- Completion
- 2016-12-31
Countries
- Croatia
Study Locations
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