---
title: Gastric CLEANsing by Intravenous AZithromycin in Urgent Endoscopy
nct_id: NCT06077916
overall_status: COMPLETED
phase: NA
sponsor: Clinical Hospital Colentina
study_type: INTERVENTIONAL
primary_condition: Upper Gastrointestinal Bleeding
countries: Romania
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06077916.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06077916"
ct_last_update_post_date: 2026-01-16
last_seen_at: "2026-05-12T07:27:16.184Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Gastric CLEANsing by Intravenous AZithromycin in Urgent Endoscopy

**Official Title:** The Efficiency and Safety of Intravenous Azithromycin in Preparation of Endoscopy for Upper Gastrointestinal Bleeding

**NCT ID:** [NCT06077916](https://clinicaltrials.gov/study/NCT06077916)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 224
- **Lead Sponsor:** Clinical Hospital Colentina
- **Collaborators:** Spitalul clinic judetean de urgenta Craiova, Spitalul clinic judetean de urgenta "Pius Brinzeu", Timisoara, Spitalul universitar de urgenta Elias, Bucuresti, Spitalul clinic de urgenta, Bucuresti, Spitalul clinic Judetean de Urgenta, Constanta, Spitalul Clinic de Urgenţǎ Bucureşti, Spitalul Universitar de Urgenta Militar Bucuresti, Spitalul Judetean de Urgenta Tulcea, Spitalul de Urgenta Prof. Dr. Agrippa Ionescu, Spitalul Universitar de Urgență București, Institutul de Gastroenterologie si Hepatologie Iasi, Institutul Regional de Gastroenterologie si Hepatologie Prof.dr.Octavian Fodor, Cluj
- **Conditions:** Upper Gastrointestinal Bleeding
- **Start Date:** 2023-10-01
- **Completion Date:** 2025-11-01
- **CT.gov Last Update:** 2026-01-16

## 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.

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Control** (PLACEBO_COMPARATOR) — iv perfusion of 250 mL of 0.9% saline solution
- **Azithromycin** (EXPERIMENTAL) — iv perfusion of 500 mg azithromycin in 250 mL of 0.9% saline solution

## Interventions

- **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

- **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)
- **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

- **Toronto Upper Gastrointestinal Cleaning Score** _(time frame: up to 12 hours)_
- **Total hospitalization** _(time frame: one month)_
- **Number of blood units transfused** _(time frame: one month)_
- **Adverse events** _(time frame: one month)_
- **Duration of endoscopy** _(time frame: up to 12 hours after admission)_
- **Score of endoscopist satisfaction on a 4-item scale** _(time frame: up to 12 hours)_

## Locations (1)

- Colentina Clinical Hospital, Bucharest, Bucharest, Romania

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.colentina clinical hospital|bucharest|bucharest|romania` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06077916*  
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