Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics

NCT02951702 | Completed Phase 4 Results

• 1 other identifier: 940920-2
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if oral vancomycin used as primary Clostridium difficile prophylaxis can reduce the incidence of this infection in high-risk patients.

Conditions

Clostridium Difficile Infection; Prophylaxis; Vancomycin

Outcome Measures

Primary Outcomes (1)

• Clostridium Difficile Infection Occurrence

  The incidence of clostridium difficile infection as detected for GDH/toxin positive or PCR if the GDH/toxin is equivocal.

  Within 4 weeks from the completion of antibiotic treatment

Secondary Outcomes (2)

• Time to Clostridium Difficile Infection Occurence

  Within 4 weeks from completion of antibiotic treatment

• Clostridium Difficile Infection Severity

  Within 4 weeks from completion of antibiotic treatment

Study Arms (2)

Control

NO INTERVENTION

This will be the historical arm that has not received oral vancomycin but match criteria for "high risk"

Vancomycin Oral

EXPERIMENTAL

This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician Intervention type: drug, vancomycin 125 mg daily

Drug: Vancomycin Oral

Interventions

Vancomycin Oral DRUG

This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician

Also known as: Oral vancomycin; vancomycin

Vancomycin Oral

Eligibility Criteria

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

You may qualify if:

• "High-risk" patients defined as: age older than 65, on gastric acid suppression, and select antibiotics
• Gastric acid suppression includes proton pump inhibitors and histamine-2 receptor antagonists
• Selected antibiotics include fluoroquinolone (ciprofloxacin, levofloxacin), clindamycin, a 3rd or 4th generation cephalosporin, a broad-spectrum aminopenicillin (ampicillin-sulbactam, piperacillin-tazobactam), or a carbapenem

You may not qualify if:

• Failure to meet all three requirements for "high risk"
• Vancomycin allergy
• Receipt of medications that also treat Clostridium difficile (metronidazole, rifaximin, fidaxomicin)
• Pregnant or breastfeeding

Sponsors & Collaborators

• St. Luke's Hospital, Chesterfield, Missouri: lead

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

• O'Brien JA, Lahue BJ, Caro JJ, Davidson DM. The emerging infectious challenge of clostridium difficile-associated disease in Massachusetts hospitals: clinical and economic consequences. Infect Control Hosp Epidemiol. 2007 Nov;28(11):1219-27. doi: 10.1086/522676. Epub 2007 Oct 3.

  PMID: 17926270 BACKGROUND

• Cohen SH, Gerding DN, Johnson S, Kelly CP, Loo VG, McDonald LC, Pepin J, Wilcox MH; Society for Healthcare Epidemiology of America; Infectious Diseases Society of America. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the society for healthcare epidemiology of America (SHEA) and the infectious diseases society of America (IDSA). Infect Control Hosp Epidemiol. 2010 May;31(5):431-55. doi: 10.1086/651706.

  PMID: 20307191 BACKGROUND

• Owens RC Jr, Donskey CJ, Gaynes RP, Loo VG, Muto CA. Antimicrobial-associated risk factors for Clostridium difficile infection. Clin Infect Dis. 2008 Jan 15;46 Suppl 1:S19-31. doi: 10.1086/521859.

  PMID: 18177218 BACKGROUND

• Magill SS, Edwards JR, Bamberg W, Beldavs ZG, Dumyati G, Kainer MA, Lynfield R, Maloney M, McAllister-Hollod L, Nadle J, Ray SM, Thompson DL, Wilson LE, Fridkin SK; Emerging Infections Program Healthcare-Associated Infections and Antimicrobial Use Prevalence Survey Team. Multistate point-prevalence survey of health care-associated infections. N Engl J Med. 2014 Mar 27;370(13):1198-208. doi: 10.1056/NEJMoa1306801.

  PMID: 24670166 BACKGROUND

• Marra F, Ng K. Controversies Around Epidemiology, Diagnosis and Treatment of Clostridium difficile Infection. Drugs. 2015 Jul;75(10):1095-118. doi: 10.1007/s40265-015-0422-x.

  PMID: 26113167 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

• Johnson S. Editorial Commentary: Potential Risks and Rewards With Prophylaxis for Clostridium difficile Infection. Clin Infect Dis. 2016 Sep 1;63(5):654-5. doi: 10.1093/cid/ciw424. Epub 2016 Jun 28. No abstract available.

  PMID: 27358349 BACKGROUND

MeSH Terms

Conditions

Clostridium Infections

Interventions

Vancomycin

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

Limitations and Caveats

Underpowered study; primary outcome relied upon patient's developing CDI while in the hospital or follow up at the study hospital.

Results Point of Contact

• Title: Ryan Medas, Pharm.D.
• Organization: St. Luke's Hospital

ryan.medas@stlukes-stl.com

314-205-6053

Study Officials

• Ryan E Medas, PharmD

  St. Luke's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PGY2 Pharmacy Internal Medicine Resident

Study Record Dates

• First Submitted: October 30, 2016
• First Posted: November 1, 2016
• Study Start: November 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 27, 2017
• Results First Posted: December 27, 2017

Record last verified: 2017-11