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

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: Completed
• Conditions: Upper Gastrointestinal Bleeding
• Intervention / Treatment: Drug: Saline solution; Drug: Azithromycin

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 as will any adverse events.

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Bucharest
    • Bucharest, Bucharest, Romania, 020125
      • Colentina Clinical Hospital

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toronto Upper Gastrointestinal Cleaning Score	visualization quality per upper GI segment	up to 12 hours
Total hospitalization	total duration of hospital stay	one month
Number of blood units transfused	Number of blood units transfused	one month
Adverse events	all advers events	one month
Duration of endoscopy	Duration of endoscopy	up to 12 hours after admission
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 5-items	up to 12 hours

Collaborators and Investigators

• Sponsor: Clinical Hospital Colentina
• Collaborators: Spitalul Universitar de Urgență București; Spitalul Clinic de Urgenţǎ Bucureşti; Spitalul clinic judetean de urgenta Craiova; Spitalul clinic judetean de urgenta "Pius Brinzeu", Timisoara; Spitalul universitar de urgenta Elias, Bucuresti; Spitalul clinic de urgenta, Bucuresti; Spitalul clinic Judetean de Urgenta, Constanta; Spitalul Universitar de Urgenta Militar Bucuresti; Spitalul Judetean de Urgenta Tulcea; Spitalul de Urgenta Prof. Dr. Agrippa Ionescu; Institutul de Gastroenterologie si Hepatologie Iasi; Institutul Regional de Gastroenterologie si Hepatologie Prof.dr.Octavian Fodor, Cluj
• Investigators: Principal Investigator: Bogdan Mateescu, Prof, Clinical Hospital Colentina

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): August 10, 2025
• Study Completion (Actual): November 1, 2025

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 (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Pathological Conditions, Signs and Symptoms; Gastrointestinal Hemorrhage; Organic Chemicals; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Macrolides; Lactones; Erythromycin; Polyketides; Azithromycin; Saline Solution
• 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