Acute PancreatitisPhase 4IMPROWENCT02897206
Imipenem Prophylaxis in Patients With Acute Pancreatitis
A Phase 4 study testing Imipenem in people with Acute Pancreatitis, run by University Hospital Rijeka at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Imipenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteCroatia
- Study dates
- Oct 2014to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- known immune deficiency
- patients with chronic pancreatitis
- patients unwilling to participate in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Imipenem Prophylaxis of Infectious Complications in Patients With Acute Pancreatitis
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
- Being tested
- Imipenem, Placebo
- Keywords
- Acute pancreatitis, Antibiotic prophylaxis, Imipenem-cilastatin, Infected pancreatic necrosis, Infection, Organ failure
- Medical subject headings
- Pancreatitis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImipenemDrug
Also called Imipenem-cilastatin
A wide-spectre antibiotic from the carbapenem group
PlaceboDrug
An imipenem-matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Imipenem group | Experimental | Imipenem 3 x 500 mg i.v. daily ideally for 10 days (minimum 7 days, maximum 21 days) Receives: Drug: Imipenem |
| Placebo group | Placebo comparator | Identical placebo administered in identical dosage, timing and duration. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infectious complications
Measured: 30 days
Secondary outcomes (7)
Mortality
Measured: 30 days
Number of patients with Systemic Inflammatory Response Syndrome (SIRS)
SIRS was defined as presence of at least two following parameters for a continuous period of ≥ 48 hours: body temperature >38°C or <36°C; heart rate >90 beats per minute; hyperventilation with a respiratory rate >20 breath per minute or a PaCO2 < 32 mmHg; and white blood cell count >12000/mm3 or <4000/mm3.
Measured: 30 days
Local complications
Measured: 30 days
Systemic complications
Measured: 30 days
Number of patients with persistent and transitory organ failure (cardiovascular, respiratory, renal)
Marshall organ dysfunction scoring system (MODS) was used to define organ failure in the case of cardiovascular, renal and respiratory system function.
Measured: 30 days
Surgical interventions
The investigators will register the number of patients requiring surgical interventions for acute pancreatitis.
Measured: 30 days
Serious adverse events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startOct 2014
- Primary completionDec 2016
- Study completionDec 2016
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 Acute PancreatitisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Rijeka
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rijeka
- Responsible party
- Principal investigator, Goran Poropat, University Hospital Rijeka
- Investigators
- Davor Stimac, MD, PhD, Principal investigator, Department of Gastroenterology, University Hospital Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897206
- Sponsor's protocol ID
- 13.06.1.2.30
- Acronym
- IMPROWE
- Status last verified
- Jun 2017
- First submitted
- 20 Dec 2015
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31404018
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imipenem Prophylaxis of Infectious Complications in Patients With Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT02897206
- Acronym / sponsor ID
- IMPROWE / 13.06.1.2.30
- Conditions
- Acute Pancreatitis
- Keywords
- Acute pancreatitis, Antibiotic prophylaxis, Imipenem-cilastatin, Infected pancreatic necrosis, Infection, Organ failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University Hospital RijekaUniversity, hospital or other
- Collaborators
- University of Rijeka
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Sep 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imipenem group | Experimental | Drug: ImipenemImipenem 3 x 500 mg i.v. daily ideally for 10 days (minimum 7 days, maximum 21 days) |
| Placebo group | Placebo comparator | Drug: PlaceboIdentical placebo administered in identical dosage, timing and duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| ImipenemAlso: Imipenem-cilastatinA wide-spectre antibiotic from the carbapenem group | Drug | Imipenem group |
| PlaceboAn imipenem-matching placebo | Drug | Placebo group |
Primary outcome
Infectious complications
Time frame: 30 days
7 secondary outcomes
Mortality
Time frame: 30 days
Number of patients with Systemic Inflammatory Response Syndrome (SIRS)
Time frame: 30 days
Local complications
Time frame: 30 days
Systemic complications
Time frame: 30 days
Number of patients with persistent and transitory organ failure (cardiovascular, respiratory, renal)
Time frame: 30 days
Surgical interventions
Time frame: 30 days
Serious adverse events
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Derived from this study: PubMed 31404018Poropat 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Davor Stimac, MD, PhD principal investigator
Department of Gastroenterology, University Hospital Rijeka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Imipenem in people with Acute Pancreatitis, run by University Hospital Rijeka at 1 site in Croatia.
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 9 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: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infectious complications (time frame: 30 days). 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 NCT02897206, 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 20 Jun 2017.