Comparing the Outcome in Patients of Acute Pancreatitis, With and Without Prophylactic Antibiotics

NCT02212392 | Completed Phase 1

• 1 other identifier: ap3
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The use of prophylactic antibiotics is beneficial in reducing the extrapancreatic infections and shorter hospital stay in patients of acute pancreatitis as compared to controls.

Conditions

Acute Pancreatitis

Keywords

acute pancreatitis

Outcome Measures

Primary Outcomes (2)

• Extrapancreatic infections

  it includes infections other than pancreas.It includes the bronchopulmonary infections and the urinary tract infection. Cultures of blood ,urine and sputum was performed in patients who develop fever ˃380C and high peripheral white blood count (leucocytosis ≥10,000/mm3) on blood complete picture. The cultures isolated the organism responsible for the infection.

  14 days

• Duration of hospital stay

  It will be measured in terms of mean number of days (i.e. from the day of admission in surgical ward to the day of discharge.)

  average 2 weeks.

Study Arms (2)

control

NO INTERVENTION

This arm was not given any prophylactic antibiotics. Patients were managed in the surgical ward by post graduate residents under the supervision of consultants

Antibiotics

EXPERIMENTAL

this arm was given IV antibiotics, prophylactically, right from the day of admission. They were given intravenous broad spectrum (MEROPENEM) twice daily at 12 hours interval for 7-10 days

Drug: Meropenem

Interventions

Meropenem DRUG

inj. MEROPENEM IV 1 gram twice daily at 12 hours interval for 7-10 days

Antibiotics

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18 to 70 years of age with diagnosis of acute pancreatitis both mild and sever necrotizing pancreatitis.
• Patients who present within 48 hours of onset of symptoms.

You may not qualify if:

• Patients who present after 48 hours of onset of symptoms.
• Patients already taking antibiotics.
• Patients who are immune compromised
• Patients with debilitating illness i.e. tuberculosis, chronic liver disease.
• Patients with trauma, and multiple visceral injuries
• Patients with diagnosed malignancy

Sponsors & Collaborators

• Benazir Bhutto Hospital, Rawalpindi: lead

Study Sites (1)

Benazir Bhutto Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (6)

• Garcia-Barrasa A, Borobia FG, Pallares R, Jorba R, Poves I, Busquets J, Fabregat J. A double-blind, placebo-controlled trial of ciprofloxacin prophylaxis in patients with acute necrotizing pancreatitis. J Gastrointest Surg. 2009 Apr;13(4):768-74. doi: 10.1007/s11605-008-0773-7. Epub 2008 Dec 11.

  PMID: 19082671 BACKGROUND

• Bhopal FG, Azhar F, Mahmood S, Iqbal M. Acute pancreatitis; management, morbidity and mortality experience in a surgical unit. Professional Med J 2011;18: 001-007

  BACKGROUND

• Cullimore J, Cotter L, Gonzalez A. Antibiotics in acute necrotising pancreatitis. Lancet. 2008 Mar 29;371(9618):1072; author reply 1072. doi: 10.1016/S0140-6736(08)60483-3. No abstract available.

  PMID: 18374839 BACKGROUND

• Stevens T, Parsi MA, Walsh RM. Acute pancreatitis: problems in adherence to guidelines. Cleve Clin J Med. 2009 Dec;76(12):697-704. doi: 10.3949/ccjm.76a.09060.

  PMID: 19952294 BACKGROUND

• Manes G, Uomo I, Menchise A, Rabitti PG, Ferrara EC, Uomo G. Timing of antibiotic prophylaxis in acute pancreatitis: a controlled randomized study with meropenem. Am J Gastroenterol. 2006 Jun;101(6):1348-53. doi: 10.1111/j.1572-0241.2006.00567.x.

  PMID: 16771960 BACKGROUND

• Xue P, Deng LH, Zhang ZD, Yang XN, Wan MH, Song B, Xia Q. Effect of antibiotic prophylaxis on acute necrotizing pancreatitis: results of a randomized controlled trial. J Gastroenterol Hepatol. 2009 May;24(5):736-42. doi: 10.1111/j.1440-1746.2008.05758.x. Epub 2009 Feb 12.

  PMID: 19220676 BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Interventions

Meropenem

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Fazal H Shah, MBBS, FCPS I

  Benazir Bhutto Hospital, Rawalpindi

  PRINCIPAL INVESTIGATOR

• Sohail Rashid, MBBS, FCPS

  Benazir Bhutto Hospital, Rawalpindi

  STUDY CHAIR

• Bilal Altaf, MBBS, FCPS I

  Benazir Bhutto Hospital, Rawalpindi

  STUDY CHAIR

• Muhammad Hanif, MBBS, FCPS

  Benazir Bhutto Hospital, Rawalpindi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident General surgery

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 8, 2014
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 8, 2014

Record last verified: 2014-08

Locations

PA (1)