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Completed

NCT Number: NCT06077916

Gastric CLEANsing by Intravenous AZithromycin in Urgent Endoscopy

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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Key information

Conditions

Upper Gastrointestinal Bleeding Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colentina Clinical Hospital

Bucharest, 020125, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azithromycin

Drug

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

Saline Solution

Drug

placebo consisting of saline solution 250 mL is administered

Primary outcomes

  1. Toronto Upper Gastrointestinal Cleaning Score

    Time frame: up to 12 hours after admission

    Quality of endoscopic visualization during urgent upper GI endo according to the Toronto Score (higher scores >8/12 mean good bowel cleanliness)

  2. Need for second look endoscopy

    Time frame: up to 48 hours after endoscopy

    Physician judgement on need for repeat endoscopy due to low Toronto score

Secondary outcomes

  1. Toronto Upper Gastrointestinal Cleaning Score

    Time frame: up to 12 hours

    visualization quality per upper GI segment

  2. Total hospitalization

    Time frame: one month

    total duration of hospital stay

  3. Number of blood units transfused

    Time frame: one month

    Number of blood units transfused

  4. Adverse events

    Time frame: one month

    all advers events

  5. Duration of endoscopy

    Time frame: up to 12 hours after admission

    Duration of endoscopy

  6. Score of endoscopist satisfaction on a 4-item scale

    Time frame: up to 12 hours

    semiquantitative measure of satisfaction with cleanliness of the upper GI tract according to visual analog scale of 5-items

Sponsors and collaborators

Lead sponsor

Clinical Hospital Colentina

Other

Collaborators

  • Institutul Regional de Gastroenterologie si Hepatologie Prof.dr.Octavian Fodor, Cluj
  • Institutul de Gastroenterologie si Hepatologie Iasi
  • Spitalul Clinic de Urgenţǎ Bucureşti
  • Spitalul Judetean de Urgenta Tulcea
  • Spitalul Universitar de Urgenta Militar Bucuresti
  • Spitalul Universitar de Urgență București
  • Spitalul clinic Judetean de Urgenta, Constanta
  • Spitalul clinic de urgenta, Bucuresti
  • Spitalul clinic judetean de urgenta "Pius Brinzeu", Timisoara
  • Spitalul clinic judetean de urgenta Craiova
  • Spitalul de Urgenta Prof. Dr. Agrippa Ionescu
  • Spitalul universitar de urgenta Elias, Bucuresti

Registry information

Official study title

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

Acronym: CLEAN-AZ

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 11, 2023
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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