A Multicentre, Randomised, Double-blind, Placebo-controlled, Study on the Use of Prophylactic Meropenem Therapy in Subjects with Severe Acute Necrotizing Pancreatitis
- Conditions
- severe acute necrotizing pancreatitis
- Registration Number
- EUCTR2004-000795-14-LT
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
Provision of written informed consentSubjects male or female, 18 years of age or older. Diagnosis of necrotizing pancreatitis within 120 hours * following onset of symptoms/ first reported symptoms. Primary diagnosis to be confirmed by contrast-enhanced CT evidence of ³ 30% necrosis of the pancreas.Or if ³ 30% necrosis is not present or cannot be confirmed, a contrast-enhanced CT scan showing extensive or multiple peripancreatic fluid collections and pancreatic edema (Balthazar grade E) with either C-reactive protein (CRP).120 mg/L or a MOD score of >2 is acceptable.Or where a subject is, in the clinical judgement of the investigator, unsuitable for a contrast-enhanced CT scan, the following may be accepted for inclusion:A non enhanced CT scan showing extensive or multiple peripancreatic fluid collections and pancreatic edema (Balthazar grade E) with either C-reactive protein (CRP).120 mg/L or a MOD score of >2 is acceptable. This option is particularly recommended for subjects with pre-existing renal impairment, with creatinine>180µmol?l (2mg/dL)*Randomisation, and receipt of first study drug, should also be within 120 hours of onset of symptoms of pancreatitis. It is therefore recommended that diagnosis of pancreatitis is confirmed within sufficient time after start of symptoms to allow completion screening assessments prior to randomisation within the 120 hour post-onset period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
The clinical management plan of the primary care team includes peritoneal lavage for treatment of pancreatitis. A confirmed diagnosis of necrotizing pancreatitis will not be possible within 120 hours of onset of symptoms of pancreatitis.The subject has received an investigational drug or device within 30 days prior to study entry.The subject has received >48 hours of antibiotic therapy between onset of symptoms of pancreatitis and diagnosis of necrotizing pancreatitis.The subject will require continuation of non-protocolled antibiotic therapy after randomisation. The subject has known or suspected anaphylactic or other type 1 (immediate) hypersensitivity reactions to cephalosporins, penicillins or carbapenems. The subject is receiving, or will require, probenecid therapy (see section 3.4.4).The subject has a rapidly progressing underlying disease or marked immunosuppression that would preclude evaluation of therapy. The criteria to be employed include: pre-morbid malignancy metastatic to brain, peritoneum (if ascites present), lung, or liver; a haematological malignancy; AIDS; immunosuppression for maintenance of an organ transplant. The subject is neutropenic (absolute neutrophil count < 1000/mm3). The subject has cirrhosis, severity of Child’s grade C. There is not a commitment on the part of the clinical care team, the subject, or the subject’s family to full, aggressive support including operative intervention if needed. The subject is a pregnant and/or nursing female (a serum or urine gonadotropin pregnancy test will be obtained on all premenopausal women prior to study drug administration). The subject was previously enrolled in this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Main objective : To determine if prophylactic intravenous antibiotic therapy with meropenem prevents the development of pancreatic or peripancreatic infection in subjects with non-infected necrotizing pancreatitis.;Secondary Objective: Secondary objectives : To evaluate subsidiary outcomes of prophylactic intravenous antibiotic therapy in subjects with non-infectednecrotizing pancreatitis. These outcomes to be: time to onset of pancreatic/peripancreatic infection, subject mortality, changes in organ dysfunction, requirement for operative or interventional radiological drainage techniques and incidence of non-pancreatic infections;Primary end point(s): Efficacy: Development of pancreatic or peripancreatic infection within 42 days following the day of randomisation.
- Secondary Outcome Measures
Name Time Method