Study Summary
This trial will help researchers understand if giving antibiotics to people before they undergo the ERCP procedure can help prevent cholangitis, a condition where the bile ducts become inflamed.
Treatment Effectiveness
Phase-Based Effectiveness
Phase 4
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: 1 week
1 week
Days of hospitalization
Proportion of patients who develop Post-ERCP Cholangitis as defined by the revised Tokyo criterion.
Proportion of patients who develop adverse events of antibiotics
Trial Safety
Phase-Based Safety
This is further along than 85% of similar trials
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2 Treatment Groups
Antibiotic arm
1 of 2
No Antibiotic arm
1 of 2
Active Control
200 Total Participants · 2 Treatment Groups
Primary Treatment: Antibiotic arm · No Placebo Group · Phase 4
Antibiotic armActiveComparator Group · 2 Interventions: Levofloxacin, Ceftriaxone · Intervention Types: Drug, Drug
No Antibiotic armNoIntervention Group · 1 Intervention: No Antibiotic arm · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 week
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
850 Previous Clinical Trials
1,433,806 Total Patients Enrolled
2 Trials studying Cholangitis
1,456 Patients Enrolled for Cholangitis
James BuxbaumPrincipal InvestigatorUniversity of Southern California Health Science Center
Eligibility Criteria
Age 18 - 90 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are between the ages of 18 to 90 and are having a procedure called ERCP to treat blockages or other issues in your bile duct.
References
- Khashab, Mouen A., Krishnavel V. Chithadi, Ruben D. Acosta, David H. Bruining, Vinay Chandrasekhara, Mohamad A. Eloubeidi, Robert D. Fanelli, et al.. 2015. “Antibiotic Prophylaxis for GI Endoscopy”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/j.gie.2014.08.008.
- Bai, Yu, Fei Gao, Jun Gao, Duo-Wu Zou, and Zhao-Shen Li. 2009. “Prophylactic Antibiotics Cannot Prevent Endoscopic Retrograde Cholangiopancreatography-induced Cholangitis”. Pancreas. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mpa.0b013e318189fl6d.
- Johannes, Catherine B, Najat Ziyadeh, John D Seeger, Ed Tucker, Christoph Reiter, and Gerald Faich. 2007. “Incidence of Allergic Reactions Associated with Antibacterial Use in a Large, Managed Care Organisation”. Drug Safety. Springer Science and Business Media LLC. doi:10.2165/00002018-200730080-00007.
- van den Hazel, Sven J.. 1996. “Piperacillin to Prevent Cholangitis After Endoscopic Retrograde Cholangiopancreatography”. Annals of Internal Medicine. American College of Physicians. doi:10.7326/0003-4819-125-6-199609150-00002.
- Glomsaker, Tom, Kjetil Søreide, Geir Hoff, Lars Aabakken, Jon Arne Søreide, and On behalf of the Norwegian Gastronet ERCP group. 2011. “Contemporary Use of Endoscopic Retrograde Cholangiopancreatography (ERCP): A Norwegian Prospective, Multicenter Study”. Scandinavian Journal of Gastroenterology. Informa UK Limited. doi:10.3109/00365521.2011.594085.
- Sauter, G., B. Grabein, G. Huber, G. A. Mannes, G. Ruckdeschel, and T. Sauerbruch. 1990. “Antibiotic Prophylaxis of Infectious Complications with Endoscopic Retrograde Cholangiopancreatography. A Randomized Controlled Study”. Endoscopy. Georg Thieme Verlag KG. doi:10.1055/s-2007-1012830.
- Christensen, Merete, Peter Matzen, Svend Schulze, and Jacob Rosenberg. 2004. “Complications of ERCP: A Prospective Study”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/s0016-5107(04)02169-8.
- Cotton, Peter B., Patrick Connor, Elaine Rawls, and Joseph Romagnuolo. 2008. “Infection After ERCP, and Antibiotic Prophylaxis: A Sequential Quality-improvement Approach over 11 Years”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/j.gie.2007.06.065.
- Brand M, Bizos D, O'Farrell P Jr. Antibiotic prophylaxis for patients undergoing elective endoscopic retrograde cholangiopancreatography. Cochrane Database Syst Rev. 2010 Oct 6;(10):CD007345. doi: 10.1002/14651858.CD007345.pub2. Review.
- Kiriyama, Seiki, Tadahiro Takada, Steven M. Strasberg, Joseph S. Solomkin, Toshihiko Mayumi, Henry A. Pitt, Dirk J. Gouma, et al.. 2013. “TG13 Guidelines for Diagnosis and Severity Grading of Acute Cholangitis (with Videos)”. Journal of Hepato-biliary-pancreatic Sciences. Wiley. doi:10.1007/s00534-012-0561-3.
- Cotton, Peter B., Donald A. Garrow, Joseph Gallagher, and Joseph Romagnuolo. 2009. “Risk Factors for Complications After ERCP: A Multivariate Analysis of 11,497 Procedures over 12 Years”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/j.gie.2008.10.039.
- Carignan, Alex, Catherine Allard, Jacques Pépin, Benoit Cossette, Vincent Nault, and Louis Valiquette. 2008. “Risk Ofclostridium Difficileinfection After Perioperative Antibacterial Prophylaxis Before and During an Outbreak of Infection Due to a Hypervirulent Strain”. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1086/588291.
- Andriulli, Angelo, Silvano Loperfido, Grazia Napolitano, Grazia Niro, Maria Rosa Valvano, Fulvio Spirito, Alberto Pilotto, and Rosario Forlano. 2007. “Incidence Rates of Post-ercp Complications: A Systematic Survey of Prospective Studies”. The American Journal of Gastroenterology. Ovid Technologies (Wolters Kluwer Health). doi:10.1111/j.1572-0241.2007.01279.x.
- Bodger, Keith, Katherine Bowering, Sanchoy Sarkar, Elizabeth Thompson, and Michael G. Pearson. 2011. “All-cause Mortality After First ERCP in England: Clinically Guided Analysis of Hospital Episode Statistics with Linkage to Registry of Death”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/j.gie.2011.06.007.
- Andriulli A, Loperfido S, Napolitano G, Niro G, Valvano MR, Spirito F, Pilotto A, Forlano R. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol. 2007 Aug;102(8):1781-8. doi: 10.1111/j.1572-0241.2007.01279.x. Epub 2007 May 17.
- Kiriyama S, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Pitt HA, Gouma DJ, Garden OJ, Buchler MW, Yokoe M, Kimura Y, Tsuyuguchi T, Itoi T, Yoshida M, Miura F, Yamashita Y, Okamoto K, Gabata T, Hata J, Higuchi R, Windsor JA, Bornman PC, Fan ST, Singh H, de Santibanes E, Gomi H, Kusachi S, Murata A, Chen XP, Jagannath P, Lee S, Padbury R, Chen MF, Dervenis C, Chan AC, Supe AN, Liau KH, Kim MH, Kim SW; Tokyo Guidelines Revision Committee. TG13 guidelines for diagnosis and severity grading of acute cholangitis (with videos). J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):24-34. doi: 10.1007/s00534-012-0561-3.
- Brand M, Bizos D, O'Farrell P Jr. Antibiotic prophylaxis for patients undergoing elective endoscopic retrograde cholangiopancreatography. Cochrane Database Syst Rev. 2010 Oct 6;(10):CD007345. doi: 10.1002/14651858.CD007345.pub2.
- van den Hazel SJ, Speelman P, Dankert J, Huibregtse K, Tytgat GN, van Leeuwen DJ. Piperacillin to prevent cholangitis after endoscopic retrograde cholangiopancreatography. A randomized, controlled trial. Ann Intern Med. 1996 Sep 15;125(6):442-7. doi: 10.7326/0003-4819-125-6-199609150-00002.
- Christensen M, Matzen P, Schulze S, Rosenberg J. Complications of ERCP: a prospective study. Gastrointest Endosc. 2004 Nov;60(5):721-31. doi: 10.1016/s0016-5107(04)02169-8.
- Johannes CB, Ziyadeh N, Seeger JD, Tucker E, Reiter C, Faich G. Incidence of allergic reactions associated with antibacterial use in a large, managed care organisation. Drug Saf. 2007;30(8):705-13. doi: 10.2165/00002018-200730080-00007.
- ASGE Standards of Practice Committee, Khashab MA, Chithadi KV, Acosta RD, Bruining DH, Chandrasekhara V, Eloubeidi MA, Fanelli RD, Faulx AL, Fonkalsrud L, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Shaukat A, Wang A, Cash BD. Antibiotic prophylaxis for GI endoscopy. Gastrointest Endosc. 2015 Jan;81(1):81-9. doi: 10.1016/j.gie.2014.08.008. Epub 2014 Nov 11. No abstract available.
- Sauter G, Grabein B, Huber G, Mannes GA, Ruckdeschel G, Sauerbruch T. Antibiotic prophylaxis of infectious complications with endoscopic retrograde cholangiopancreatography. A randomized controlled study. Endoscopy. 1990 Jul;22(4):164-7. doi: 10.1055/s-2007-1012830.
- Carignan A, Allard C, Pepin J, Cossette B, Nault V, Valiquette L. Risk of Clostridium difficile infection after perioperative antibacterial prophylaxis before and during an outbreak of infection due to a hypervirulent strain. Clin Infect Dis. 2008 Jun 15;46(12):1838-43. doi: 10.1086/588291.
- Glomsaker T, Soreide K, Hoff G, Aabakken L, Soreide JA; Norwegian Gastronet ERCP group. Contemporary use of endoscopic retrograde cholangiopancreatography (ERCP): a Norwegian prospective, multicenter study. Scand J Gastroenterol. 2011 Sep;46(9):1144-51. doi: 10.3109/00365521.2011.594085. Epub 2011 Jun 22.
- Cotton PB, Connor P, Rawls E, Romagnuolo J. Infection after ERCP, and antibiotic prophylaxis: a sequential quality-improvement approach over 11 years. Gastrointest Endosc. 2008 Mar;67(3):471-5. doi: 10.1016/j.gie.2007.06.065. Epub 2007 Dec 3.
- ASGE Standards of Practice Committee; Khashab MA, Chithadi KV, Acosta RD, Bruining DH, Chandrasekhara V, Eloubeidi MA, Fanelli RD, Faulx AL, Fonkalsrud L, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Shaukat A, Wang A, Cash BD. Antibiotic prophylaxis for GI endoscopy. Gastrointest Endosc. 2015 Jan;81(1):81-9. doi: 10.1016/j.gie.2014.08.008. Epub 2014 Nov 11. No abstract available.
- James Buxbaum 2017. "Antibiotics to Decrease Post ERCP Cholangitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03087656.
Frequently Asked Questions
Are seniors aged 70 and over being considered for inclusion in this research project?
"Applicants must be between 18-90 years old to qualify for this study, outlined in the conditions of participation." - Anonymous Online Contributor
Unverified Answer
Has the FDA sanctioned Antibiotic arm for therapeutic use?
"The safety of the Antibiotic arm has been rated a 3, as it is part of Phase 4 trials which indicates approval." - Anonymous Online Contributor
Unverified Answer
Is recruitment for this research still happening?
"This medical experiment has been actively recruiting participants since March 29th 2017 and is still seeking individuals, as evidenced by its most recent update on December 6th 2021." - Anonymous Online Contributor
Unverified Answer
How many participants are currently involved in this research endeavor?
"Affirmative. According to clinicaltrials.gov, this experiment was initially posted on March 29th 2017 and is actively seeking participants; the most recent edit occurred December 6th 2021. The research requires 200 people at a single location." - Anonymous Online Contributor
Unverified Answer
What bacterial infections most regularly respond to antibiotic treatment?
"Antibiotic arm therapy is regularly utilized to treat abscesses, as well as pyoderma, post-operative infection prevention, and prophylactic defense against neonatal conjunctivitis caused by gonorrhoea." - Anonymous Online Contributor
Unverified Answer
What qualifications must prospective participants meet for this clinical trial?
"This clinical trial is interested in recruiting approximately 200 individuals who are afflicted with cholangitis and between 18 to 90 years old." - Anonymous Online Contributor
Unverified Answer