The PROCAP study.
Research type
Research Study
Full title
PROCalcitonin-based algorithm for antibiotic use in Acute Pancreatitis (PROCAP): A randomised controlled trial.
IRAS ID
241392
Contact name
Ajith Siriwardena
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
ISRCTN Number
ISRCTN50584992
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Acute pancreatitis is the medical term for inflammation of the pancreas. Acute pancreatitis causes severe abdominal pain. Treatment involves giving fluids through a drip, pain control and oxygen by mask. About one third of patients have severe acute pancreatitis and need intensive care including being placed on a ventilator to help them breath. As inflammation of the pancreas is similar to infection it can be difficult to distinguish between inflammation and infection in patients with acute pancreatitis. In turn, this leads to over-use of antibiotics in these patients. Antibiotics are ineffective unless there is infection. Over-use of antibiotics leads to the emergence of antibiotic resistant bacteria. These are often called “super-bugs” and infection with these is a major concern in modern medicine and a specific problem in patients with acute pancreatitis. For patients, over-use of antibiotics is associated with unpleasant side effects such as diarrhoea and sore mouth. Procalcitonin (PCT) is a protein secreted in response to infection. Levels rise with infection and fall after treatment. Algorithms (formulas) have been developed to use PCT measurement to guide antibiotic use when infection is suspected: if PCT is raised, antibiotics are given but not if PCT is low. PROCAP (PROCalcitonin in Acute Pancreatitis) is a randomised controlled trial evaluating whether a PCT algorithm reduces antibiotic use in acute pancreatitis. Patients will be allocated to one of two groups: the control group will receive standard care. The intervention group will also receive standard care but additionally have antibiotic use guided by the PCT algorithm. The study assesses whether the PCT algorithm reduces antibiotic use. The study will monitor to ensure no harm from the PCT algorithm and will also monitor the development of resistant bacteria, the risk of death and the cost-effectiveness of treatment.
REC name
North West - Haydock Research Ethics Committee
REC reference
18/NW/0255
Date of REC Opinion
27 Apr 2018
REC opinion
Favourable Opinion