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Gastric CLEANsing by Intravenous AZithromycin in Urgent Endoscopy (CLEAN-AZ)

Primary Purpose

Upper Gastrointestinal Bleeding

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Azithromycin
Saline solution
Sponsored by
Clinical Hospital Colentina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Upper Gastrointestinal Bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: acute upper GI bleeding (<12 hours) Exclusion Criteria: prokinetics <12 hours allergy to azithromycin use of contraindicated drugs (due to interactions) pregnancy physician option

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Control

    Azithromycin

    Arm Description

    iv perfusion of 250 mL of 0.9% saline solution

    iv perfusion of 500 mg azithromycin in 250 mL of 0.9% saline solution

    Outcomes

    Primary Outcome Measures

    Toronto Upper Gastrointestinal Cleaning Score
    Quality of endoscopic visualization during urgent upper GI endo according to the Toronto Score (higher scores >8/10 mean good bowel cleanliness)
    Need for second look endoscopy
    Physician judgement on need for repeat endoscopy due to low Toronto score

    Secondary Outcome Measures

    Toronto Upper Gastrointestinal Cleaning Score
    visualization quality per upper GI segment
    Total hospitalization
    total duration of hospital stay
    Number of blood units transfused
    Number of blood units transfused
    Adverse events
    all advers events
    Duration of endoscopy
    Duration of endoscopy
    Score of endoscopist satisfaction on a 4-item scale
    semiquantitative measure of satisfaction with cleanliness of the upper GI tract according to visual analog scale of 4-items

    Full Information

    First Posted
    September 28, 2023
    Last Updated
    October 4, 2023
    Sponsor
    Clinical Hospital Colentina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06077916
    Brief Title
    Gastric CLEANsing by Intravenous AZithromycin in Urgent Endoscopy
    Acronym
    CLEAN-AZ
    Official Title
    The Efficiency and Safety of Intravenous Azithromycin in Preparation of Endoscopy for Upper Gastrointestinal Bleeding
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2024 (Anticipated)
    Study Completion Date
    November 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Clinical Hospital Colentina

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will test the hypothesis that azythromycin is efficient and safe in cleansing the upper gastrointestinal tract for endoscopic examination in the case of acute bleeding.
    Detailed Description
    In this study patients with upper GI bleeding will be randomzied to either i.v. azythromycin or placebo in order to evaluate the efficiency and safety of azythromycin for upper GI cleanliness during diagnostic endoscopy. A validated upper GI cleanliness score (Toronto score with values up to 10) and a visual analog scale will be used to evaluate cleanliness. Need for repeat endoscopy due to poor preparation, duration of hospitalization and requirement for blood transfusions during hospitalization will also be assessed. Adverse venets due to medication will also be recorded carefully.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Upper Gastrointestinal Bleeding

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    223 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    iv perfusion of 250 mL of 0.9% saline solution
    Arm Title
    Azithromycin
    Arm Type
    Experimental
    Arm Description
    iv perfusion of 500 mg azithromycin in 250 mL of 0.9% saline solution
    Intervention Type
    Drug
    Intervention Name(s)
    Azithromycin
    Intervention Description
    azithromycin is reconstituted and administered according to standard prescription indications in 250 mL saline solution
    Intervention Type
    Drug
    Intervention Name(s)
    Saline solution
    Intervention Description
    placebo consisting of saline solution 250 mL is administered
    Primary Outcome Measure Information:
    Title
    Toronto Upper Gastrointestinal Cleaning Score
    Description
    Quality of endoscopic visualization during urgent upper GI endo according to the Toronto Score (higher scores >8/10 mean good bowel cleanliness)
    Time Frame
    up to 12 hours after admission
    Title
    Need for second look endoscopy
    Description
    Physician judgement on need for repeat endoscopy due to low Toronto score
    Time Frame
    up to 48 hours after endoscopy
    Secondary Outcome Measure Information:
    Title
    Toronto Upper Gastrointestinal Cleaning Score
    Description
    visualization quality per upper GI segment
    Time Frame
    up to 12 hours
    Title
    Total hospitalization
    Description
    total duration of hospital stay
    Time Frame
    one month
    Title
    Number of blood units transfused
    Description
    Number of blood units transfused
    Time Frame
    one month
    Title
    Adverse events
    Description
    all advers events
    Time Frame
    one month
    Title
    Duration of endoscopy
    Description
    Duration of endoscopy
    Time Frame
    up to 12 hours after admission
    Title
    Score of endoscopist satisfaction on a 4-item scale
    Description
    semiquantitative measure of satisfaction with cleanliness of the upper GI tract according to visual analog scale of 4-items
    Time Frame
    up to 12 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: acute upper GI bleeding (<12 hours) Exclusion Criteria: prokinetics <12 hours allergy to azithromycin use of contraindicated drugs (due to interactions) pregnancy physician option
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bogdan Mateescu, Prof
    Phone
    +40021 317 3245
    Email
    bogmateescu@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrei Voiosu, PhD
    Email
    andreivoiosu@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bogdan Mateescu, Prof
    Organizational Affiliation
    Clinical Hospital Colentina
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Gastric CLEANsing by Intravenous AZithromycin in Urgent Endoscopy

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