CLEAN-AZ: Gastric CLEANsing by Intravenous AZithromycin in Urgent Endoscopy

Sponsor

Clinical Hospital Colentina (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06077916

Collaborator

(none)

223

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Upper Gastrointestinal Bleeding	Drug: Azithromycin Drug: Saline solution	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

223 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

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: 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

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: 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

Outcome Measures

Primary Outcome Measures

Toronto Upper Gastrointestinal Cleaning Score [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)
Need for second look endoscopy [up to 48 hours after endoscopy]
Physician judgement on need for repeat endoscopy due to low Toronto score

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Clinical Hospital Colentina

Investigators

Principal Investigator: Bogdan Mateescu, Prof, Clinical Hospital Colentina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrei Voiosu, Investigator, Clinical Hospital Colentina

ClinicalTrials.gov Identifier:

NCT06077916

Other Study ID Numbers:

10/27.03.2023

First Posted:

Oct 11, 2023

Last Update Posted:

Oct 11, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gastrointestinal Hemorrhage

Hemorrhage

Azithromycin

Study Results

No Results Posted as of Oct 11, 2023