Cleansing the stomach with intravenous azithromycin for urgent endoscopy
The Efficiency and Safety of Intravenous Azithromycin in Preparation of Endoscopy for Upper Gastrointestinal Bleeding
This study is testing if giving azithromycin through an IV can help clean the stomach better for patients with serious upper gastrointestinal bleeding before they have an endoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 223 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinical Hospital Colentina Academic / other |
| Locations | 1 site (Bucuresti, Bucharest) |
| Trial ID | NCT06077916 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of intravenous azithromycin in cleansing the upper gastrointestinal tract for patients experiencing acute upper gastrointestinal bleeding. Participants will be randomly assigned to receive either azithromycin or a placebo, and the cleanliness of the upper GI tract will be assessed using a validated scoring system. Additional outcomes such as the need for repeat endoscopy, length of hospital stay, and blood transfusion requirements will also be monitored. Adverse events related to the medication will be carefully recorded to ensure patient safety.
Who should consider this trial
Good fit: Ideal candidates are patients presenting with acute upper gastrointestinal bleeding within the last 12 hours.
Not a fit: Patients with allergies to azithromycin, those who have received prokinetics within the last 12 hours, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the preparation quality for urgent endoscopic procedures, potentially leading to better patient outcomes.
How similar studies have performed: While the use of azithromycin for this specific purpose is novel, similar studies have explored the use of antibiotics for gastrointestinal preparation with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bucuresti, Bucharest
- Colentina Clinical Hospital — Bucuresti, Bucharest, Romania (Recruiting)
Study contacts
- Principal investigator: Bogdan Mateescu, Prof — Clinical Hospital Colentina
- Study coordinator: Bogdan Mateescu, Prof
- Email: bogmateescu@gmail.com
- Phone: +40021 317 3245
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.