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Gastric CLEANsing by Intravenous AZithromycin in Urgent Endoscopy

NCT ID: NCT06077916

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-11-01

Brief Summary

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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.

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Detailed Description

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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

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Upper Gastrointestinal Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

iv perfusion of 250 mL of 0.9% saline solution

Group Type PLACEBO_COMPARATOR

Saline solution

Intervention Type DRUG

placebo consisting of saline solution 250 mL is administered

Azithromycin

iv perfusion of 500 mg azithromycin in 250 mL of 0.9% saline solution

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

azithromycin is reconstituted and administered according to standard prescription indications in 250 mL saline solution

Saline solution

Intervention Type DRUG

placebo consisting of saline solution 250 mL is administered

Interventions

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Azithromycin

azithromycin is reconstituted and administered according to standard prescription indications in 250 mL saline solution

Intervention Type DRUG

Saline solution

placebo consisting of saline solution 250 mL is administered

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spitalul clinic judetean de urgenta Craiova

UNKNOWN

Sponsor Role collaborator

Spitalul clinic judetean de urgenta "Pius Brinzeu", Timisoara

UNKNOWN

Sponsor Role collaborator

Spitalul universitar de urgenta Elias, Bucuresti

UNKNOWN

Sponsor Role collaborator

Spitalul clinic de urgenta, Bucuresti

UNKNOWN

Sponsor Role collaborator

Spitalul clinic Judetean de Urgenta, Constanta

UNKNOWN

Sponsor Role collaborator

Spitalul Clinic de Urgenţǎ Bucureşti

UNKNOWN

Sponsor Role collaborator

Spitalul Universitar de Urgenta Militar Bucuresti

UNKNOWN

Sponsor Role collaborator

Spitalul Judetean de Urgenta Tulcea

UNKNOWN

Sponsor Role collaborator

Spitalul de Urgenta Prof. Dr. Agrippa Ionescu

UNKNOWN

Sponsor Role collaborator

Spitalul Universitar de Urgență București

UNKNOWN

Sponsor Role collaborator

Institutul de Gastroenterologie si Hepatologie Iasi

UNKNOWN

Sponsor Role collaborator

Institutul Regional de Gastroenterologie si Hepatologie Prof.dr.Octavian Fodor, Cluj

UNKNOWN

Sponsor Role collaborator

Clinical Hospital Colentina

OTHER

Sponsor Role lead

Responsible Party

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Andrei Voiosu

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bogdan Mateescu, Prof

Role: PRINCIPAL_INVESTIGATOR

Clinical Hospital Colentina

Locations

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Colentina Clinical Hospital

Bucharest, Bucharest, Romania

Site Status

Countries

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Romania

Other Identifiers

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10/27.03.2023

Identifier Type: -

Identifier Source: org_study_id

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