NCT06077916

Gastric CLEANsing by Intravenous AZithromycin in Urgent Endoscopy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Clinical Hospital Colentina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 as will any adverse events.

Conditions

• Upper Gastrointestinal Bleeding

Interventions

Type	Name	Description
DRUG	Azithromycin	azithromycin is reconstituted and administered according to standard prescription indications in 250 mL saline solution
DRUG	Saline solution	placebo consisting of saline solution 250 mL is administered

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-08-10
• Completion: 2025-11-01
• First posted: 2023-10-11
• Last updated: 2026-01-16

Locations

1 site across 1 country: Romania