<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/NCT04402359</url>
  </required_header>
  <id_info>
    <org_study_id>ICU-3-20</org_study_id>
    <nct_id>NCT04402359</nct_id>
  </id_info>
  <brief_title>Usage of Meropenem/Gentamicin Versus Ceftazidime/Avibactam in ARDS</brief_title>
  <official_title>Comparative Study Between Usage of Meropenem/Gentamicin Versus Ceftazidime/Avibactam in the Treatment of ARDS Induced by Both Lung Trauma and VAP</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdul Aziz Specialist Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Abdul Aziz Specialist Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a prospective double blind study conducted on 200 polytrauma patients admitted to&#xD;
      King Abdul-Aziz Specialized Hospital, Taif, KSA between July 2018 and December 2019 in&#xD;
      surgical ICU. All patients were having severe chest trauma, contused lungs either with or&#xD;
      without severe head trauma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients of Group A received meropenem one gram slowly IV infusion every 8 hours for 14 days&#xD;
      and gentamicin 7 milligram (mg)/ Kilogram body weight per day slowly IV infusion once daily&#xD;
      only for one week, while patients of Group B received ceftazidime 2 grams and avibactam 500&#xD;
      mg every 8 hours for 14 days in solution for injection(sodium chloride 9 mg/mL (0.9%), sodium&#xD;
      chloride 4.5 mg/mL, dextrose 25 mg/mL, 0.45% sodium chloride, 2.5% dextrose and/or Lactated&#xD;
      Ringer's solution). The solution for injection should be administered over 120 minutes. •&#xD;
      Temperature was measured every 3 hours for 2 weeks. • ABG was done every 8 hours for 2 weeks.&#xD;
      • CBC including white cell count was done daily and for 2 weeks. • Complete renal functions&#xD;
      daily (urea and creatinine serum level) for 2 weeks. Any patient showing rise in the&#xD;
      creatinine level was recorded and excluded from the study. • Chest X-ray for all the patients&#xD;
      was ordered after intubation and with onset of ventilation and every 24 hours for 2 weeks. •&#xD;
      All patients received anti-stress (Omeprazole 20 mg IV every 12 hours). • Oro-gastric tubes&#xD;
      were inserted to all patients and feeding was started within 24 hours.Daily evaluation for&#xD;
      conscious level and need for sedation and ventilation were done for all patients. •&#xD;
      Tracheobronchial lavage was obtained by bronchoscopy 2 times a week and sent for qualitative&#xD;
      culture for 2 weeks. • Blood culture was also taken 2 times per week for 2 weeks. • The&#xD;
      planned duration of the study is two weeks from diagnosis of VAP and starting the antibiotics&#xD;
      so any patients who failed to be weaned within this period were considered morbidity and&#xD;
      recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 5, 2018</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 28, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Weeks</target_duration>
  <primary_outcome>
    <measure>systemic change of tissue oxygenation</measure>
    <time_frame>2 weeks</time_frame>
    <description>improvement of arterial partial pressure of oxygen</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Ventilator Associated Pneumonia</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>Patients of Group A received meropenem one gram slowly IV infusion every 8 hours for 14 days and gentamicin 7 milligram (mg)/ Kilogram body weight per day slowly IV infusion once daily only for one week after ventilator for 2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>received ceftazidime 2 grams and avibactam 500 mg every 8 hours for 14 days in solution for injection(sodium chloride 9 mg/mL (0.9%), sodium chloride 4.5 mg/mL, dextrose 25 mg/mL, 0.45% sodium chloride, 2.5% dextrose and/or Lactated Ringer's solution). The solution for injection should be administered over 120 minutes.after ventilator for 2 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>meropenem</intervention_name>
    <description>meropenem one gram slowly IV infusion every 8 hours for 14 days</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ceftazidime 2 grams and avibactam 500</intervention_name>
    <description>received ceftazidime 2 grams and avibactam 500 mg every 8 hours for 14 days in solution for injection(sodium chloride 9 mg/mL (0.9%), sodium chloride 4.5 mg/mL, dextrose 25 mg/mL, 0.45% sodium chloride, 2.5% dextrose and/or Lactated Ringer's solution).</description>
    <arm_group_label>Group B</arm_group_label>
    <other_name>Avycaz</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ventilator</intervention_name>
    <description>all patients selected to be ventilated for 14 days</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        200 polytrauma patients admitted to King Abdul-Aziz Specialized Hospital, Taif, KSA between&#xD;
        July 2018 and December 2019 in surgical ICU.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        patients with respiratory failure diagnosed by ABG,chest Xray, and clinical by Arterial&#xD;
        oxygen low saturation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any other types of respiratory failure rather than trauma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>King abd el Aziz specialist hospital</name>
      <address>
        <city>Ta'if</city>
        <zip>21944</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>June 6, 2020</last_update_submitted>
  <last_update_submitted_qc>June 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia, Ventilator-Associated</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meropenem</mesh_term>
    <mesh_term>Ceftazidime</mesh_term>
    <mesh_term>Avibactam</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>To evaluate and compare the effect of use of combination of meropenem/gentamicin versus the use of ceftazidime/avibactam in the treatment of ARDS induced by both VAP and lung contusion and early weaning from the ventilator and compare their effect on the mortality rate.</ipd_description>
  </patient_data>
  <!-- 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/NCT04402359
org study id: ICU-3-20
nct id: NCT04402359
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This was a prospective double blind study conducted on 200 polytrauma patients admitted to
      King Abdul-Aziz Specialized Hospital, Taif, KSA between July 2018 and December 2019 in
      surgical ICU. All patients were having severe chest trauma, contused lungs either with or
      without severe head trauma.
Patients of Group A received meropenem one gram slowly IV infusion every 8 hours for 14 days
      and gentamicin 7 milligram (mg)/ Kilogram body weight per day slowly IV infusion once daily
      only for one week, while patients of Group B received ceftazidime 2 grams and avibactam 500
      mg every 8 hours for 14 days in solution for injection(sodium chloride 9 mg/mL (0.9%), sodium
      chloride 4.5 mg/mL, dextrose 25 mg/mL, 0.45% sodium chloride, 2.5% dextrose and/or Lactated
      Ringer's solution). The solution for injection should be administered over 120 minutes. •
      Temperature was measured every 3 hours for 2 weeks. • ABG was done every 8 hours for 2 weeks.
      • CBC including white cell count was done daily and for 2 weeks. • Complete renal functions
      daily (urea and creatinine serum level) for 2 weeks. Any patient showing rise in the
      creatinine level was recorded and excluded from the study. • Chest X-ray for all the patients
      was ordered after intubation and with onset of ventilation and every 24 hours for 2 weeks. •
      All patients received anti-stress (Omeprazole 20 mg IV every 12 hours). • Oro-gastric tubes
      were inserted to all patients and feeding was started within 24 hours.Daily evaluation for
      conscious level and need for sedation and ventilation were done for all patients. •
      Tracheobronchial lavage was obtained by bronchoscopy 2 times a week and sent for qualitative
      culture for 2 weeks. • Blood culture was also taken 2 times per week for 2 weeks. • The
      planned duration of the study is two weeks from diagnosis of VAP and starting the antibiotics
      so any patients who failed to be weaned within this period were considered morbidity and
      recorded.
observational model: Cohort
time perspective: Prospective
measure: systemic change of tissue oxygenation
time frame: 2 weeks
description: improvement of arterial partial pressure of oxygen
arm group label: Group A
description: Patients of Group A received meropenem one gram slowly IV infusion every 8 hours for 14 days and gentamicin 7 milligram (mg)/ Kilogram body weight per day slowly IV infusion once daily only for one week after ventilator for 2 weeks
arm group label: Group B
description: received ceftazidime 2 grams and avibactam 500 mg every 8 hours for 14 days in solution for injection(sodium chloride 9 mg/mL (0.9%), sodium chloride 4.5 mg/mL, dextrose 25 mg/mL, 0.45% sodium chloride, 2.5% dextrose and/or Lactated Ringer's solution). The solution for injection should be administered over 120 minutes.after ventilator for 2 weeks
intervention type: Drug
intervention name: meropenem
description: meropenem one gram slowly IV infusion every 8 hours for 14 days
arm group label: Group A
intervention type: Drug
intervention name: ceftazidime 2 grams and avibactam 500
description: received ceftazidime 2 grams and avibactam 500 mg every 8 hours for 14 days in solution for injection(sodium chloride 9 mg/mL (0.9%), sodium chloride 4.5 mg/mL, dextrose 25 mg/mL, 0.45% sodium chloride, 2.5% dextrose and/or Lactated Ringer's solution).
arm group label: Group B
other name: Avycaz
intervention type: Device
intervention name: ventilator
description: all patients selected to be ventilated for 14 days
arm group label: Group A
arm group label: Group B
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Saudi Arabia
responsible party type: Sponsor
mesh term: Pneumonia, Ventilator-Associated
mesh term: Meropenem
mesh term: Ceftazidime
mesh term: Avibactam
sharing ipd: No
ipd description: To evaluate and compare the effect of use of combination of meropenem/gentamicin versus the use of ceftazidime/avibactam in the treatment of ARDS induced by both VAP and lung contusion and early weaning from the ventilator and compare their effect on the mortality rate.