NCT07407491 Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis
| NCT ID | NCT07407491 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National University of Malaysia |
| Condition | Acute Cholangitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 172 participants |
| Start Date | 2024-07-09 |
| Primary Completion | 2026-07-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 172 participants in total. It began in 2024-07-09 with a primary completion date of 2026-07-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Does intraductal administration of antibiotics during endoscopic retrograde cholangiopancreatography (ERCP), in addition to standard systemic antibiotic therapy, improve clinical outcomes in patients with acute cholangitis compared with standard systemic antibiotic therapy alone?
Eligibility Criteria
Inclusion Criteria: * The patients diagnosed with mild and moderate acute cholangitis based on TG 18 * Planned for ERCP within 48 hours * 18 years old and above Exclusion Criteria: * Severe acute cholangitis * History of antibiotic hypersensitivity * Receiving cancer chemotherapy, steroids, or immunosuppressive agents * Concomitant infections * Recent biliary interventions such as percutaneous transhepatic biliary drainage (PTBD) within last 3 months * Known or suspected perforated tympanic membrane, myasthenia gravis
Contact & Investigator
Azlanudin Azman
PRINCIPAL INVESTIGATOR
Universiti Kebangsaan Malaysia Medical Centre
Frequently Asked Questions
Who can join the NCT07407491 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Cholangitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07407491 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07407491 currently recruiting?
Yes, NCT07407491 is actively recruiting participants. Contact the research team at warrentiew@gmail.com for enrollment information.
Where is the NCT07407491 trial being conducted?
This trial is being conducted at Cheras, Malaysia.
Who is sponsoring the NCT07407491 clinical trial?
NCT07407491 is sponsored by National University of Malaysia. The principal investigator is Azlanudin Azman at Universiti Kebangsaan Malaysia Medical Centre. The trial plans to enroll 172 participants.