Upper Gastrointestinal BleedingCLEAN-AZNCT06077916
Gastric CLEANsing by Intravenous AZithromycin in Urgent Endoscopy
A study testing Azithromycin and Saline solution in people with Upper Gastrointestinal Bleeding, run by Clinical Hospital Colentina at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- What is being tested?
- Azithromycin and Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteRomania
- Study dates
- 1 Oct 2023to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute upper GI bleeding (<12 hours)
Who cannot join
- prokinetics <12 hours
- allergy to azithromycin
- use of contraindicated drugs (due to interactions)
- pregnancy
- physician option
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficiency and Safety of Intravenous Azithromycin in Preparation of Endoscopy for Upper Gastrointestinal Bleeding
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.
Read the 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.
- Conditions
- Upper Gastrointestinal Bleeding
- Being tested
- Azithromycin, Saline solution
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
azithromycin is reconstituted and administered according to standard prescription indications in 250 mL saline solution
Saline solutionDrug
placebo consisting of saline solution 250 mL is administered
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | iv perfusion of 250 mL of 0.9% saline solution Receives: Drug: Saline solution |
| Azithromycin | Experimental | iv perfusion of 500 mg azithromycin in 250 mL of 0.9% saline solution Receives: Drug: Azithromycin; Drug: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 12 hours after admission
Need for second look endoscopy
Physician judgement on need for repeat endoscopy due to low Toronto score
Measured: up to 48 hours after endoscopy
Secondary outcomes (6)
Toronto Upper Gastrointestinal Cleaning Score
visualization quality per upper GI segment
Measured: up to 12 hours
Total hospitalization
total duration of hospital stay
Measured: one month
Number of blood units transfused
Number of blood units transfused
Measured: one month
Adverse events
all advers events
Measured: one month
Duration of endoscopy
Duration of endoscopy
Measured: up to 12 hours after admission
Score of endoscopist satisfaction on a 4-item scale
semiquantitative measure of satisfaction with cleanliness of the upper GI tract according to visual analog scale of 5-items
Measured: up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Oct 2023
- Primary completion10 Aug 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Colentina
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Andrei Voiosu, Clinical Hospital Colentina
- Investigators
- Bogdan Mateescu, Prof, Principal investigator, Clinical Hospital Colentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077916
- Sponsor's protocol ID
- 10/27.03.2023
- Acronym
- CLEAN-AZ
- Status last verified
- Dec 2025
- First submitted
- 28 Sep 2023
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency and Safety of Intravenous Azithromycin in Preparation of Endoscopy for Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT06077916
- Acronym / sponsor ID
- CLEAN-AZ / 10/27.03.2023
- Conditions
- Upper Gastrointestinal Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Clinical Hospital ColentinaUniversity, hospital or other
- 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
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 10 Aug 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Saline solutioniv perfusion of 250 mL of 0.9% saline solution |
| Azithromycin | Experimental | Drug: Azithromycin, Drug: Saline solutioniv perfusion of 500 mg azithromycin in 250 mL of 0.9% saline solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- acute upper GI bleeding (<12 hours)
Key exclusion criteria (5 listed)
- prokinetics <12 hours
- allergy to azithromycin
- use of contraindicated drugs (due to interactions)
- pregnancy
- physician option
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycinazithromycin is reconstituted and administered according to standard prescription indications in 250 mL saline solution | Drug | Azithromycin |
| Saline solutionplacebo consisting of saline solution 250 mL is administered | Drug | Azithromycin, Control |
Primary outcome
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
6 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bogdan Mateescu, Prof principal investigator
Clinical Hospital Colentina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Azithromycin and Saline solution in people with Upper Gastrointestinal Bleeding, run by Clinical Hospital Colentina at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toronto Upper Gastrointestinal Cleaning Score (time frame: up to 12 hours after admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.