Oral Vancomycin for Preventing Clostridium Difficile Recurrence

NCT03200093 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: CIC 1745-B-17 Laguio-Vila
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Clostridium Difficile Infection

Keywords

Clostridium difficile; C diff; Oral Vancomycin; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 90-day recurrent Clostridium difficile infection

  90 days

• 30-day hospital re-admission

  30 days

• 30-day mortality

  30 days

Other Outcomes (5)

• Impact of duration of systemic antibiotics on Clostridium difficile recurrence

  90 days

• Impact of acid-suppressing medications on Clostridium difficile recurrence

  90 days

• Impact of age on Clostridium difficile recurrence

  90 days

Study Arms (2)

Oral vancomycin

EXPERIMENTAL

Oral vancomycin solution 125 mg in 2.5 mL, combined with 2.5 ml Ora-Sweet solution, to total 5 mL. Taken by mouth once daily for: 1. If the total duration of systemic antibiotics is less than or equal to 14 days, oral vancomycin will be taken for the duration of the systemic antibiotics plus three days. 2. If the total duration of systemic antibiotics is greater than 14 days, oral vancomycin will be taken for the duration of the systemic antibiotics plus seven days.

Drug: Oral Vancomycin

Placebo arm

PLACEBO COMPARATOR

Ora-Sweet 5 mL Taken by mouth once daily for: 1. If the total duration of systemic antibiotics is less than or equal to 14 days, placebo will be taken for the duration of the systemic antibiotics plus three days. 2. If the total duration of systemic antibiotics is greater than 14 days, placebo will be taken for the duration of the systemic antibiotics plus seven days.

Drug: Placebo

Interventions

Oral Vancomycin DRUG

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.

Also known as: Study drug

Oral vancomycin

Placebo DRUG

Ora-Sweet 5mL taken by mouth once daily.

Also known as: Study placebo

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rochester General Hospital: lead

Study Sites (1)

Rochester General Hospital

Rochester, New York, 14621, United States

Location

Related Publications (8)

• 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.

  PMID: 25714160 BACKGROUND

• 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.

  PMID: 23439232 BACKGROUND

• 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.

  PMID: 24669194 BACKGROUND

• 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.

  PMID: 27025623 BACKGROUND

• 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.

  PMID: 22450732 BACKGROUND

• 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.

  PMID: 23323867 BACKGROUND

• Carignan A, Poulin S, Martin P, Labbe AC, Valiquette L, Al-Bachari H, Montpetit LP, Pepin 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.

  PMID: 27619835 BACKGROUND

• 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.

  PMID: 27318333 BACKGROUND

MeSH Terms

Conditions

Clostridium Infections

Interventions

Vancomycin; Drug Evaluation

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Maryrose R Laguio-Vila, MD

  Rochester General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After enrollment, study pharmacists will randomize the participants to receive either oral vancomycin or placebo. Participants, care providers, investigators, and outcomes assessors will be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: Randomized, placebo-controlled

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: June 27, 2017
• Study Start: June 8, 2017
• Primary Completion: April 22, 2021
• Study Completion: April 22, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)