<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02212392</url>
  </required_header>
  <id_info>
    <org_study_id>ap3</org_study_id>
    <nct_id>NCT02212392</nct_id>
  </id_info>
  <brief_title>Comparing the Outcome in Patients of Acute Pancreatitis, With and Without Prophylactic Antibiotics</brief_title>
  <official_title>COMPARING THE OUTCOME IN PATIENTS OF ACUTE PANCREATITIS, WITH AND WITHOUT PROPHYLACTIC ANTIBIOTICS.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Benazir Bhutto Hospital, Rawalpindi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Benazir Bhutto Hospital, Rawalpindi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The use of prophylactic antibiotics is beneficial in reducing the extrapancreatic infections&#xD;
      and shorter hospital stay in patients of acute pancreatitis as compared to controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute pancreatitis (AP) is an acute inflammatory condition of the pancreas that may extend to&#xD;
      local and distant extra pancreatic tissues. AP is broadly classified as mild or severe. Most&#xD;
      cases of AP are mild with excellent recovery. However 15% to 20% are severe. Bacterial&#xD;
      infections play a vital in the course of the disease. Patients with AP are prone to develop&#xD;
      extrapancreatic infections like urinary, respiratory and systemic infections. These&#xD;
      infections may result in a prolonged hospitalization, systemic inflammatory response syndrome&#xD;
      (SIRS), multi-organ system failure and death. The most common causes are gallstones and&#xD;
      alcohol intake. AP is managed by intravenous fluids, analgesia and nothing by mouth. However&#xD;
      treatment of severe pancreatitis can be challenging, particularly if multiple organ systems&#xD;
      are involved or if there are local complications. In severe acute pancreatitis, as pancreatic&#xD;
      enzymes and inflammatory mediators damage the blood vessels and leads to extravasation of&#xD;
      fluid in to third space. This fluid extravasation leads to local pancreatic necrosis and&#xD;
      end-organ failure. Assessment of severity begins in the emergency room or on admission. Signs&#xD;
      of SIRS (high or low core body temperature, tachycardia, tachypnea, low or high peripheral&#xD;
      white blood cell count) or organ failure (e.g. elevated serum creatinine) are present on&#xD;
      admission in 21% of patients with acute pancreatitis. CT should be considered about 3 days&#xD;
      after the onset of symptoms rather than immediately upon admission. Eighty per cent of cases&#xD;
      of AP are interstitial and mild; the remaining 20% are necrotizing and severe.&#xD;
&#xD;
      The role of prophylactic antibiotics in acute pancreatitis is controversial .A study&#xD;
      published in American Journal of Gastroenterology shows results favouring use of antibiotics&#xD;
      in acute pancreatitis. This study shows significant reduction in the length of&#xD;
      hospitalization in patients who were given prophylactic antibiotics.&#xD;
&#xD;
      Other Internationally conducted studies suggests that there is no or insignificant role of&#xD;
      antibiotics for mild acute pancreatitis and role of prophylactic antibiotics in sever acute&#xD;
      pancreatitis for better clinical outcome is controversial to say the least.&#xD;
&#xD;
      Rationale of this study was to emphasize that prophylactic antibiotics in patients with acute&#xD;
      pancreatitis can improve patient's out come in terms of shorter hospital stay, and reduced&#xD;
      number of extrapancreatic infections.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Extrapancreatic infections</measure>
    <time_frame>14 days</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of hospital stay</measure>
    <time_frame>average 2 weeks.</time_frame>
    <description>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.)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Acute Pancreatitis</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This arm was not given any prophylactic antibiotics. Patients were managed in the surgical ward by post graduate residents under the supervision of consultants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Antibiotics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Meropenem</intervention_name>
    <description>inj. MEROPENEM IV 1 gram twice daily at 12 hours interval for 7-10 days</description>
    <arm_group_label>Antibiotics</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between 18 to 70 years of age with diagnosis of acute pancreatitis both mild&#xD;
             and sever necrotizing pancreatitis.&#xD;
&#xD;
          -  Patients who present within 48 hours of onset of symptoms.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who present after 48 hours of onset of symptoms.&#xD;
&#xD;
          -  Patients already taking antibiotics.&#xD;
&#xD;
          -  Patients who are immune compromised&#xD;
&#xD;
          -  Patients with debilitating illness i.e. tuberculosis, chronic liver disease.&#xD;
&#xD;
          -  Patients with trauma, and multiple visceral injuries&#xD;
&#xD;
          -  Patients with diagnosed malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fazal H Shah, MBBS, FCPS I</last_name>
    <role>Principal Investigator</role>
    <affiliation>Benazir Bhutto Hospital, Rawalpindi</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sohail Rashid, MBBS, FCPS</last_name>
    <role>Study Chair</role>
    <affiliation>Benazir Bhutto Hospital, Rawalpindi</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bilal Altaf, MBBS, FCPS I</last_name>
    <role>Study Chair</role>
    <affiliation>Benazir Bhutto Hospital, Rawalpindi</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Muhammad Hanif, MBBS, FCPS</last_name>
    <role>Study Chair</role>
    <affiliation>Benazir Bhutto Hospital, Rawalpindi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Benazir Bhutto Hospital</name>
      <address>
        <city>Rawalpindi</city>
        <state>Punjab</state>
        <zip>46000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>19082671</PMID>
  </reference>
  <reference>
    <citation>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</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18374839</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19952294</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16771960</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19220676</PMID>
  </reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>August 6, 2014</last_update_submitted>
  <last_update_submitted_qc>August 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Benazir Bhutto Hospital, Rawalpindi</investigator_affiliation>
    <investigator_full_name>Dr.Fazal hussain Shah</investigator_full_name>
    <investigator_title>Resident General surgery</investigator_title>
  </responsible_party>
  <keyword>acute pancreatitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meropenem</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02212392
org study id: ap3
nct id: NCT02212392
lead sponsor: 
has dmc: No
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.
Acute pancreatitis (AP) is an acute inflammatory condition of the pancreas that may extend to
      local and distant extra pancreatic tissues. AP is broadly classified as mild or severe. Most
      cases of AP are mild with excellent recovery. However 15% to 20% are severe. Bacterial
      infections play a vital in the course of the disease. Patients with AP are prone to develop
      extrapancreatic infections like urinary, respiratory and systemic infections. These
      infections may result in a prolonged hospitalization, systemic inflammatory response syndrome
      (SIRS), multi-organ system failure and death. The most common causes are gallstones and
      alcohol intake. AP is managed by intravenous fluids, analgesia and nothing by mouth. However
      treatment of severe pancreatitis can be challenging, particularly if multiple organ systems
      are involved or if there are local complications. In severe acute pancreatitis, as pancreatic
      enzymes and inflammatory mediators damage the blood vessels and leads to extravasation of
      fluid in to third space. This fluid extravasation leads to local pancreatic necrosis and
      end-organ failure. Assessment of severity begins in the emergency room or on admission. Signs
      of SIRS (high or low core body temperature, tachycardia, tachypnea, low or high peripheral
      white blood cell count) or organ failure (e.g. elevated serum creatinine) are present on
      admission in 21% of patients with acute pancreatitis. CT should be considered about 3 days
      after the onset of symptoms rather than immediately upon admission. Eighty per cent of cases
      of AP are interstitial and mild; the remaining 20% are necrotizing and severe.

      The role of prophylactic antibiotics in acute pancreatitis is controversial .A study
      published in American Journal of Gastroenterology shows results favouring use of antibiotics
      in acute pancreatitis. This study shows significant reduction in the length of
      hospitalization in patients who were given prophylactic antibiotics.

      Other Internationally conducted studies suggests that there is no or insignificant role of
      antibiotics for mild acute pancreatitis and role of prophylactic antibiotics in sever acute
      pancreatitis for better clinical outcome is controversial to say the least.

      Rationale of this study was to emphasize that prophylactic antibiotics in patients with acute
      pancreatitis can improve patient's out come in terms of shorter hospital stay, and reduced
      number of extrapancreatic infections.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: Extrapancreatic infections
time frame: 14 days
description: 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.
measure: Duration of hospital stay
time frame: average 2 weeks.
description: 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.)
arm group label: control
arm group type: No Intervention
description: This arm was not given any prophylactic antibiotics. Patients were managed in the surgical ward by post graduate residents under the supervision of consultants
arm group label: Antibiotics
arm group type: Experimental
description: 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
intervention type: Drug
intervention name: Meropenem
description: inj. MEROPENEM IV 1 gram twice daily at 12 hours interval for 7-10 days
arm group label: Antibiotics
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Fazal H Shah, MBBS, FCPS I
role: Principal Investigator
affiliation: Benazir Bhutto Hospital, Rawalpindi
last name: Sohail Rashid, MBBS, FCPS
role: Study Chair
affiliation: Benazir Bhutto Hospital, Rawalpindi
last name: Bilal Altaf, MBBS, FCPS I
role: Study Chair
affiliation: Benazir Bhutto Hospital, Rawalpindi
last name: Muhammad Hanif, MBBS, FCPS
role: Study Chair
affiliation: Benazir Bhutto Hospital, Rawalpindi
facility: 
country: Pakistan
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
responsible party type: Principal Investigator
investigator affiliation: Benazir Bhutto Hospital, Rawalpindi
investigator full name: Dr.Fazal hussain Shah
investigator title: Resident General surgery
mesh term: Pancreatitis
mesh term: Meropenem