Oral Vancomycin for Preventing Clostridium Difficile Recurrence

Clostridium Difficile Infection Clinical Trial

Official title:

Secondary Prophylaxis With Oral Vancomycin for Clostridium Difficile Recurrence: A Randomized Control Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03200093
• Other study ID #: CIC 1745-B-17 Laguio-Vila
• Status: Terminated
• Phase: Phase 4
• Start date: June 8, 2017
• Est. completion date: April 22, 2021

Study information

• Verified date: April 2021
• Source: Rochester General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the role of oral vancomycin in the prevention of recurrent Clostridium difficile for hospitalized patients receiving systemic antibiotic therapy. Half of participants will receive oral vancomycin daily, while the other half will receive a placebo.

Description:

Clostridium difficile colitis is a significant cause of morbidity and mortality among hospitalized patients. Following the first episode, up to 15% of people experience recurrent disease. A major risk factor for recurrent disease is exposure to systemic antibiotics.

Oral vancomycin given four times daily is one of the treatments for Clostridium difficile infection; it is not known if giving oral vancomycin at a lower dose such as once daily may help prevent recurrences. Oral vancomycin may be most helpful in preventing recurrences when given to patients at greatest risk of recurrent disease, such as when they are receiving systemic antibiotics.

To evaluate this, the investigators propose comparing the rates of recurrent Clostridium difficile infection in patients who receive oral vancomycin with systemic antibiotics to when patients take systemic antibiotics alone.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: April 22, 2021
• Est. primary completion date: April 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years and older

• Any history of Clostridium difficile infection based on a positive Clostridium difficile stool test performed at a lab affiliated with Rochester Regional Health System or patient report

• A new in-patient admission, with an antibiotic treatment plan for greater than 48 hours

Exclusion Criteria:

• Documented allergy and/or adverse drug reaction to vancomycin

• Pregnant

• Patients who are admitted with a current episode of Clostridium difficile infection

• Patients with total colectomy

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• Recurrence

Intervention

Drug:
• Oral Vancomycin
Oral vancomycin solution 125 mg in 2.5 mL combined with 2.5 mL Ora-Sweet. A total of 5 mL combined solution taken by mouth once daily.
• Placebo
Ora-Sweet 5mL taken by mouth once daily.

Locations

Country	Name	City	State
United States	Rochester General Hospital	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Rochester General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (8)

Brandt LJ, Aroniadis OC, Mellow M, Kanatzar A, Kelly C, Park T, Stollman N, Rohlke F, Surawicz C. Long-term follow-up of colonoscopic fecal microbiota transplant for recurrent Clostridium difficile infection. Am J Gastroenterol. 2012 Jul;107(7):1079-87. doi: 10.1038/ajg.2012.60. Epub 2012 Mar 27. — View Citation

Carignan A, Poulin S, Martin P, Labbé AC, Valiquette L, Al-Bachari H, Montpetit LP, Pépin J. Efficacy of Secondary Prophylaxis With Vancomycin for Preventing Recurrent Clostridium difficile Infections. Am J Gastroenterol. 2016 Dec;111(12):1834-1840. doi: 10.1038/ajg.2016.417. Epub 2016 Sep 13. — View Citation

Gupta A, Khanna S. Community-acquired Clostridium difficile infection: an increasing public health threat. Infect Drug Resist. 2014 Mar 17;7:63-72. doi: 10.2147/IDR.S46780. eCollection 2014. Review. — View Citation

Lessa FC, Mu Y, Bamberg WM, Beldavs ZG, Dumyati GK, Dunn JR, Farley MM, Holzbauer SM, Meek JI, Phipps EC, Wilson LE, Winston LG, Cohen JA, Limbago BM, Fridkin SK, Gerding DN, McDonald LC. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015 Feb 26;372(9):825-34. doi: 10.1056/NEJMoa1408913. — View Citation

Surawicz CM, Brandt LJ, Binion DG, Ananthakrishnan AN, Curry SR, Gilligan PH, McFarland LV, Mellow M, Zuckerbraun BS. Guidelines for diagnosis, treatment, and prevention of Clostridium difficile infections. Am J Gastroenterol. 2013 Apr;108(4):478-98; quiz 499. doi: 10.1038/ajg.2013.4. Epub 2013 Feb 26. Review. — View Citation

Van Hise NW, Bryant AM, Hennessey EK, Crannage AJ, Khoury JA, Manian FA. Efficacy of Oral Vancomycin in Preventing Recurrent Clostridium difficile Infection in Patients Treated With Systemic Antimicrobial Agents. Clin Infect Dis. 2016 Sep 1;63(5):651-3. doi: 10.1093/cid/ciw401. Epub 2016 Jun 17. — View Citation

van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16. — View Citation

Vincent C, Manges AR. Antimicrobial Use, Human Gut Microbiota and Clostridium difficile Colonization and Infection. Antibiotics (Basel). 2015 Jul 3;4(3):230-53. doi: 10.3390/antibiotics4030230. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of duration of systemic antibiotics on Clostridium difficile recurrence	Comparing the frequency of a positive Clostridium difficile stool test in the 90 days following completion of systemic antibiotics, when the duration of systemic antibiotics was less than or equal to 14 days compared to longer durations.	90 days
Other	Impact of acid-suppressing medications on Clostridium difficile recurrence	Comparing the frequency of a positive Clostridium difficile stool test in the 90 days following completion of systemic antibiotics, when the participant was receiving acid-suppressing medications compared to those on none.	90 days
Other	Impact of age on Clostridium difficile recurrence	Comparing the frequency of a positive Clostridium difficile stool test in the 90 days following completion of systemic antibiotics, when the participant was older than 65 years of age compared to younger.	90 days
Other	Impact of systemic antibiotic class on Clostridium difficile recurrence	Comparing the frequency of a positive Clostridium difficile stool test in the 90 days following completion of systemic antibiotics, when the participant was receiving systemic antibiotics considered "high risk" for Clostridium difficile compared to those taking "low risk" antibiotics.	90 days
Other	Vancomycin resistance isolated	Isolation of a vancomycin-resistant bacteria during an infectious workup, if clinically indicated	90 days
Primary	30-day recurrent Clostridium difficile infection	A positive Clostridium difficile stool test in the 30 days following completion of the systemic antibiotic treatment.	30 days
Secondary	90-day recurrent Clostridium difficile infection	A positive Clostridium difficile stool test in the 90 days following completion of the systemic antibiotic treatment.	90 days
Secondary	30-day hospital re-admission	All-cause re-admission to any hospital	30 days
Secondary	30-day mortality	All-cause mortality in the 30 days following completion of the systemic antibiotics	30 days