NCT06077916

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

January 16, 2026

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

September 28, 2023

Last Update Submit

January 15, 2026

Conditions

Upper Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (2)

  • Toronto Upper Gastrointestinal Cleaning Score

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

    up to 12 hours after admission

  • Need for second look endoscopy

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

    up to 48 hours after endoscopy

Secondary Outcomes (6)

  • Toronto Upper Gastrointestinal Cleaning Score

    up to 12 hours

  • Total hospitalization

    one month

  • Number of blood units transfused

    one month

  • Adverse events

    one month

  • Duration of endoscopy

    up to 12 hours after admission

  • +1 more secondary outcomes

Study Arms (2)

Control

PLACEBO COMPARATOR

iv perfusion of 250 mL of 0.9% saline solution

Drug: Saline solution

Azithromycin

EXPERIMENTAL

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

Drug: AzithromycinDrug: Saline solution

Interventions

AzithromycinDRUG

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

Azithromycin
Saline solutionDRUG

placebo consisting of saline solution 250 mL is administered

AzithromycinControl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute upper GI bleeding (\<12 hours)

You may not qualify if:

  • prokinetics \<12 hours
  • allergy to azithromycin
  • use of contraindicated drugs (due to interactions)
  • pregnancy
  • physician option

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colentina Clinical Hospital

Bucharest, Bucharest, 020125, Romania

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

AzithromycinSaline Solution

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Bogdan Mateescu, Prof

    Clinical Hospital Colentina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 11, 2023

Study Start

October 1, 2023

Primary Completion

August 10, 2025

Study Completion

November 1, 2025

Last Updated

January 16, 2026

Record last verified: 2025-12

Locations

RO(1)