<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/NCT03784365</url>
  </required_header>
  <id_info>
    <org_study_id>SMAPP-01</org_study_id>
    <nct_id>NCT03784365</nct_id>
  </id_info>
  <brief_title>Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia</brief_title>
  <acronym>SMAPP</acronym>
  <official_title>Randomized Control Study Comparing Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asian Institute of Gastroenterology, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asian Institute of Gastroenterology, India</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Achalasia cardia is a primary oesophageal motility disorder of unknown etiology. Recently,&#xD;
      peroral endoscopic myotomy (POEM) has gained widespread acceptance as an effective treatment&#xD;
      modality for achalasia.&#xD;
&#xD;
      Major adverse events are uncommon with POEM. Since the operator works close to mediastinum&#xD;
      during the POEM procedure, there is a potential for infectious complications. Therefore,&#xD;
      intravenous antibiotics are universally used to prevent infection-related adverse events.&#xD;
      There is no fixed protocol or duration of antibiotics for the same.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      POEM is a novel minimally invasive treatment for achalasia, which emerged as an offshoot of&#xD;
      natural orifice transluminal endoscopic surgery (NOTES). Major adverse events during POEM are&#xD;
      rare and therefore, the procedure is considered safe.&#xD;
&#xD;
      Bacteremia can occur after endoscopic procedures like esophageal dilation, sclerotherapy of&#xD;
      varices, and instrumentation of obstructed bile ducts. Bacteremia has been advocated as a&#xD;
      surrogate marker for risk of infection-related complications. In POEM procedure, the&#xD;
      endoscopist works in close proximity to mediastinum and peritoneal cavity. Therefore, the&#xD;
      potential for infection-related complications is high. However, despite of different&#xD;
      antibiotic protocols at different centers, the reported incidence of infection-related&#xD;
      complications is very low. At present, prophylactic antibiotics are universally initiated&#xD;
      before starting the POEM procedure and continued for a variable duration after POEM ranging&#xD;
      from 1 day to 7 days.&#xD;
&#xD;
      Data from surgical studies indicate that prolonged administration of antibiotics for longer&#xD;
      than 24 hours may not be beneficial. Prolonged use of antibiotics not only increases the&#xD;
      costs and exposure to drug toxicity directly but also may be associated with an increased&#xD;
      risk of acquired antibiotic resistance as well as infection with Clostridium difficile.&#xD;
&#xD;
      With this background, we planned a study to evaluate the difference in the infectious&#xD;
      complications between short vs long duration antibiotic in patients with achalasia undergoing&#xD;
      POEM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">March 2020</completion_date>
  <primary_completion_date type="Anticipated">February 2020</primary_completion_date>
  <phase>Phase 3</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Infectious complications associated with POEM</measure>
    <time_frame>1 month</time_frame>
    <description>The primary outcome of the study is to estimate the difference in the incidence of infectious complications in the two groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of positive blood cultures</measure>
    <time_frame>72 hours</time_frame>
    <description>The main secondary outcome is difference in the incidence of positive blood cultures between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of serum Procalcitonin between the two groups</measure>
    <time_frame>72 hours</time_frame>
    <description>Difference in the mean serum procalcitonin values between both the groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of inflammatory markers (CRP) between the two groups</measure>
    <time_frame>72 hours</time_frame>
    <description>Both the groups will be compared for mean blood C-reactive protein (CRP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of erythrocyte sedimentation rate (ESR) between the two groups</measure>
    <time_frame>72 hours</time_frame>
    <description>Both the groups will be compared for mean ESR at 1-hour</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events associated with administration of intravenous antibiotics</measure>
    <time_frame>1-month</time_frame>
    <description>Both the groups will be compared for the incidence of complications associated with the use of intravenous antibiotics</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Achalasia Cardia</condition>
  <arm_group>
    <arm_group_label>First group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive an intravenous antibiotic for three days. The first dose will be given within half hour before the POEM procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Second group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive only one dose of intravenous antibiotic within half hour before the POEM procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>One dose of Cefo-perazone Sulbactum</intervention_name>
    <description>Antibiotic</description>
    <arm_group_label>First group</arm_group_label>
    <arm_group_label>Second group</arm_group_label>
    <other_name>Multiple doses of Cefo-perazone Sulbactum</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All the patient(aged 18-65) who underwent POEM for achalasia cardia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwillingness to give written informed consent&#xD;
&#xD;
               -  Patients with multiple co morbidities.&#xD;
&#xD;
               -  Immunocompromised patients /on steroid therapy.&#xD;
&#xD;
               -  Patients with indications for antibiotic prophylaxis (infective endocarditis).&#xD;
&#xD;
               -  Patients who have received antibiotics in the last 1 week .&#xD;
&#xD;
               -  Patients who have possible signs of infection during preparation for POEM&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohan Ramchandani</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asian Institute of Gastroenterology, Hyderabad, India</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bhushan Bhaware</last_name>
    <phone>9833022139</phone>
    <email>drbhushanbhaware3@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dr.Mohan Ramchandani</name>
      <address>
        <city>Hyderabad</city>
        <state>RED ROSE Restaurant</state>
        <zip>500082</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohan Ramchandani</last_name>
      <phone>8297918513</phone>
      <email>ramchandanimohan@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Zaheer Nabi</last_name>
      <phone>9573058810</phone>
      <email>zaheernabi1978@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>January 14, 2020</last_update_submitted>
  <last_update_submitted_qc>January 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asian Institute of Gastroenterology, India</investigator_affiliation>
    <investigator_full_name>Mohan Ramchandani</investigator_full_name>
    <investigator_title>Consultant Gastroenterologist</investigator_title>
  </responsible_party>
  <keyword>oesophageal aperistalsis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Achalasia</mesh_term>
  </condition_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/NCT03784365
org study id: SMAPP-01
nct id: NCT03784365
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Achalasia cardia is a primary oesophageal motility disorder of unknown etiology. Recently,
      peroral endoscopic myotomy (POEM) has gained widespread acceptance as an effective treatment
      modality for achalasia.

      Major adverse events are uncommon with POEM. Since the operator works close to mediastinum
      during the POEM procedure, there is a potential for infectious complications. Therefore,
      intravenous antibiotics are universally used to prevent infection-related adverse events.
      There is no fixed protocol or duration of antibiotics for the same.
POEM is a novel minimally invasive treatment for achalasia, which emerged as an offshoot of
      natural orifice transluminal endoscopic surgery (NOTES). Major adverse events during POEM are
      rare and therefore, the procedure is considered safe.

      Bacteremia can occur after endoscopic procedures like esophageal dilation, sclerotherapy of
      varices, and instrumentation of obstructed bile ducts. Bacteremia has been advocated as a
      surrogate marker for risk of infection-related complications. In POEM procedure, the
      endoscopist works in close proximity to mediastinum and peritoneal cavity. Therefore, the
      potential for infection-related complications is high. However, despite of different
      antibiotic protocols at different centers, the reported incidence of infection-related
      complications is very low. At present, prophylactic antibiotics are universally initiated
      before starting the POEM procedure and continued for a variable duration after POEM ranging
      from 1 day to 7 days.

      Data from surgical studies indicate that prolonged administration of antibiotics for longer
      than 24 hours may not be beneficial. Prolonged use of antibiotics not only increases the
      costs and exposure to drug toxicity directly but also may be associated with an increased
      risk of acquired antibiotic resistance as well as infection with Clostridium difficile.

      With this background, we planned a study to evaluate the difference in the infectious
      complications between short vs long duration antibiotic in patients with achalasia undergoing
      POEM.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Infectious complications associated with POEM
time frame: 1 month
description: The primary outcome of the study is to estimate the difference in the incidence of infectious complications in the two groups
measure: Incidence of positive blood cultures
time frame: 72 hours
description: The main secondary outcome is difference in the incidence of positive blood cultures between the two groups
measure: Comparison of serum Procalcitonin between the two groups
time frame: 72 hours
description: Difference in the mean serum procalcitonin values between both the groups
measure: Comparison of inflammatory markers (CRP) between the two groups
time frame: 72 hours
description: Both the groups will be compared for mean blood C-reactive protein (CRP)
measure: Comparison of erythrocyte sedimentation rate (ESR) between the two groups
time frame: 72 hours
description: Both the groups will be compared for mean ESR at 1-hour
measure: Adverse events associated with administration of intravenous antibiotics
time frame: 1-month
description: Both the groups will be compared for the incidence of complications associated with the use of intravenous antibiotics
arm group label: First group
arm group type: Active Comparator
description: This group will receive an intravenous antibiotic for three days. The first dose will be given within half hour before the POEM procedure.
arm group label: Second group
arm group type: Experimental
description: This group will receive only one dose of intravenous antibiotic within half hour before the POEM procedure
intervention type: Drug
intervention name: One dose of Cefo-perazone Sulbactum
description: Antibiotic
arm group label: First group
arm group label: Second group
other name: Multiple doses of Cefo-perazone Sulbactum
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Mohan Ramchandani
role: Principal Investigator
affiliation: Asian Institute of Gastroenterology, Hyderabad, India
last name: Bhushan Bhaware
phone: 9833022139
email: drbhushanbhaware3@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Asian Institute of Gastroenterology, India
investigator full name: Mohan Ramchandani
investigator title: Consultant Gastroenterologist
mesh term: Esophageal Achalasia