Gastric CLEANsing by Intravenous AZithromycin in Urgent Endoscopy

Upper Gastrointestinal Bleeding Clinical Trial

— CLEAN-AZ  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06077916
• Other study ID #: 10/27.03.2023
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: November 2023
• Source: Clinical Hospital Colentina
• Contact: Bogdan Mateescu, Prof
• Phone: +40021 317 3245
• Email: bogmateescu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 223
• Est. completion date: November 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Upper Gastrointestinal Bleeding

Intervention

Drug:
• Azithromycin
azithromycin is reconstituted and administered according to standard prescription indications in 250 mL saline solution
• Saline solution
placebo consisting of saline solution 250 mL is administered

Locations

Country	Name	City	State
Romania	Colentina Clinical Hospital	Bucuresti	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Colentina

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	up to 12 hours after admission
Primary	Need for second look endoscopy	Physician judgement on need for repeat endoscopy due to low Toronto score	up to 48 hours after endoscopy
Secondary	Toronto Upper Gastrointestinal Cleaning Score	visualization quality per upper GI segment	up to 12 hours
Secondary	Total hospitalization	total duration of hospital stay	one month
Secondary	Number of blood units transfused	Number of blood units transfused	one month
Secondary	Adverse events	all advers events	one month
Secondary	Duration of endoscopy	Duration of endoscopy	up to 12 hours after admission
Secondary	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	up to 12 hours