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

November 5, 2023 updated by: Andrei Voiosu, Clinical Hospital Colentina

The Efficiency and Safety of Intravenous Azithromycin in Preparation of Endoscopy for Upper Gastrointestinal Bleeding

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

223

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
iv perfusion of 250 mL of 0.9% saline solution
Drug: Saline solution
placebo consisting of saline solution 250 mL is administered
Experimental: Azithromycin
iv perfusion of 500 mg azithromycin in 250 mL of 0.9% saline solution
Drug: Saline solution
placebo consisting of saline solution 250 mL is administered
Drug: Azithromycin
azithromycin is reconstituted and administered according to standard prescription indications in 250 mL saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toronto Upper Gastrointestinal Cleaning Score
Time Frame: up to 12 hours after admission
Quality of endoscopic visualization during urgent upper GI endo according to the Toronto Score (higher scores >8/10 mean good bowel cleanliness)
up to 12 hours after admission
Need for second look endoscopy
Time Frame: up to 48 hours after endoscopy
Physician judgement on need for repeat endoscopy due to low Toronto score
up to 48 hours after endoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toronto Upper Gastrointestinal Cleaning Score
Time Frame: up to 12 hours
visualization quality per upper GI segment
up to 12 hours
Total hospitalization
Time Frame: one month
total duration of hospital stay
one month
Number of blood units transfused
Time Frame: one month
Number of blood units transfused
one month
Adverse events
Time Frame: one month
all advers events
one month
Duration of endoscopy
Time Frame: up to 12 hours after admission
Duration of endoscopy
up to 12 hours after admission
Score of endoscopist satisfaction on a 4-item scale
Time Frame: up to 12 hours
semiquantitative measure of satisfaction with cleanliness of the upper GI tract according to visual analog scale of 4-items
up to 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Hospital Colentina

Investigators

  • Principal Investigator: Bogdan Mateescu, Prof, Clinical Hospital Colentina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 5, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/27.03.2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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