Gastric CLEANsing by Intravenous AZithromycin in Urgent Endoscopy (CLEAN-AZ)

Clinical Hospital Colentina

Status: Completed

Conditions: Upper Gastrointestinal Bleeding

Treatments: Drug: Saline solution; Drug: Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT06077916

10/27.03.2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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224 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

iv perfusion of 250 mL of 0.9% saline solution

Treatment:

Drug: Saline solution

Azithromycin

Experimental group

Description:

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

Treatment:

Drug: Azithromycin

Drug: Saline solution