Trial: azithromycin versus erythromycin before endoscopy in upper gastrointestinal bleeding

A randomized, controlled and double-blind trial of intravenous azithromycin versus intravenous erythromycin as a single dose prior to endoscopy in upper gastrointestinal bleeding

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003339-39-ES

Enrollment

Unknown

Registered

2017-04-07

Start date

2017-05-03

Completion date

Unknown

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper gastrointestinal haemorrhage MedDRA version: 19.1 Level: PT Classification code 10046274 Term: Upper gastrointestinal haemorrhage System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: Erythromycin Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: ERYTHROMYCIN LACTOBIONATE CAS Number: 3847-29-8 Product Name: Azithromycin Product Code

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients older than 18 years with upper gastrointestinal bleeding defined as hematemesis, melena or coffee-ground hematemesist. Informed consent provided. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120

Exclusion criteria

Exclusion criteria: Allergy, interactions or contraindications to macrolides, previous administration of prokinetic agents in this episode, perforation or previous gastric surgery, history of cardiac arrhytnmias, acute myocardial infarction or cerebrovascular disease in the last 3 weeks, pregnancy or lactation.

Design outcomes

Primary

Measure	Time frame
Main Objective: Determine if intravenous azithromycin versus erythromycin as a single dose of 250 mg are equivalents (non-inferior) in quality of gastric mucosa visualization and obtaining a proper diagnostic (diagnostic efficiency) in patients with upper gastrointestinal bleeding and urgent endoscopy within 24 hours after admission.;Secondary Objective: To assess the safety of the endoscopic and therapeutic procedure: incidence of complications related to endoscopy (such as perforation of the gastrointestinal tract, bronchoaspiration or death) and serious and unexpected adverse effects related to the treatment. To determine the proportion of patients with persistent or recurrent bleeding within 24 hours. To determine the need for a second endoscopy within 24 hours when the initial procedure was not diagnostic, including those reported as normal, bleeding due to non-obvious causes or as indeterminate, either due to poor preparation or active bleeding. To determine the proportion of patients undergoing surgical treatment after the endoscopy and to identify indications and surgical risk factors. Measure the duration of the endoscopy and the units of transfused red blood cells within 48 hours. To evaluate hospital mortality during admission and morbidity;Primary end point(s): 1. Diagnostic performance: having an etiologic diagnosis. 2. Quality of gastrointestinal tract visualization during endoscopy: Subjective criteria: stomach mucosa was entirely visualized or not based on the endoscopist’s judgment. Objective criteria: using a scale of 0 to 3: 0, insufficient preparation with large volume of red or black blood and/or adherent clots that could not be removed by lavage performed through the accessory channel of the endoscope; 1, poor preparation with a moderate volume of red or black blood and/or clots that could be fully removed during the examination by active lavage through the accessory channel; 2, good preparation with a small volume of red or black blood, but no	—

Measure

Time frame

Main Objective: Determine if intravenous azithromycin versus erythromycin as a single dose of 250 mg are equivalents (non-inferior) in quality of gastric mucosa visualization and obtaining a proper diagnostic (diagnostic efficiency) in patients with upper gastrointestinal bleeding and urgent endoscopy within 24 hours after admission.;Secondary Objective: To assess the safety of the endoscopic and therapeutic procedure: incidence of complications related to endoscopy (such as perforation of the gastrointestinal tract, bronchoaspiration or death) and serious and unexpected adverse effects related to the treatment. To determine the proportion of patients with persistent or recurrent bleeding within 24 hours. To determine the need for a second endoscopy within 24 hours when the initial procedure was not diagnostic, including those reported as normal, bleeding due to non-obvious causes or as indeterminate, either due to poor preparation or active bleeding. To determine the proportion of patients undergoing surgical treatment after the endoscopy and to identify indications and surgical risk factors. Measure the duration of the endoscopy and the units of transfused red blood cells within 48 hours. To evaluate hospital mortality during admission and morbidity;Primary end point(s): 1. Diagnostic performance: having an etiologic diagnosis. 2. Quality of gastrointestinal tract visualization during endoscopy: Subjective criteria: stomach mucosa was entirely visualized or not based on the endoscopist’s judgment. Objective criteria: using a scale of 0 to 3: 0, insufficient preparation with large volume of red or black blood and/or adherent clots that could not be removed by lavage performed through the accessory channel of the endoscope; 1, poor preparation with a moderate volume of red or black blood and/or clots that could be fully removed during the examination by active lavage through the accessory channel; 2, good preparation with a small volume of red or black blood, but no

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Secondary

Measure	Time frame
Secondary end point(s): 1. Duration of the endoscopy in minutes. 2. Need for second-look endoscopy within 24 hours after the initial endoscopy. 3. Hospital mortality. 4. Morbility as aspiration during endoscopy. 5. Bleeding or rebleeding within 24 hours after the initial procedure. 6. Number of transfused blood units during the first 48 hours. 7. Endoscopy-related complications. 8. Adverse effects related to erythromycin or azithromycin;Timepoint(s) of evaluation of this end point: It has been specified in every secondary end point: during endoscopy, at 24 hours of admission, at 48 hours of admission and before discharge of the hospital.	—

Measure

Time frame

Secondary end point(s): 1. Duration of the endoscopy in minutes. 2. Need for second-look endoscopy within 24 hours after the initial endoscopy. 3. Hospital mortality. 4. Morbility as aspiration during endoscopy. 5. Bleeding or rebleeding within 24 hours after the initial procedure. 6. Number of transfused blood units during the first 48 hours. 7. Endoscopy-related complications. 8. Adverse effects related to erythromycin or azithromycin;Timepoint(s) of evaluation of this end point: It has been specified in every secondary end point: during endoscopy, at 24 hours of admission, at 48 hours of admission and before discharge of the hospital.

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Countries

Spain

Contacts

Public ContactÁREA DE ENSAYOS CLÍNICOS FARMACIA

HOSPITAL GENERAL UNIVERSITARIO DE ALICANTE

mluz.boquera@gmail.com34965933314

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026