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

NCT ID: NCT02951702

Last Updated: 2017-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-07-31

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.

Detailed Description

Clostridium difficile infection is a common healthcare-associated infection and one that is associated with significant morbidity as well as a risk for mortality. Current practice throughout the United States is targeted at infection prevention measures such as hand washing and isolation. Despite these measures, incidence of Clostridium difficile infections continue to rise as some institutions, including our own. Recently, a study published in Clinical Infectious Diseases found oral vancomycin for secondary prophylaxis to reduce the incidence of recurrence. No studies to date have evaluated primary prophylaxis with oral vancomycin. This will be a single center, prospective study to evaluate oral vancomycin use as primary Clostridium difficile prophylaxis. Patients treated by infectious disease physicians will be identified as "high risk" and after pager notification the ID physician will have the option to start oral vancomycin 125 mg by mouth daily if they determine it to be appropriate. Risk factors include age older than 65 years, taking gastric acid suppression medication, and receiving select broad-spectrum antibiotics. Oral vancomycin will be continued until de-escalation of antibiotics or hospital discharge and patients will be evaluated for Clostridium difficile infection development from the current hospital admission up to 4 weeks following antibiotic discontinuation.

Conditions

Clostridium Difficile Infection; Prophylaxis; Vancomycin

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Vancomycin Oral

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

Group Type: EXPERIMENTAL

Vancomycin Oral

Intervention Type: DRUG

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

Interventions

Vancomycin Oral

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

Intervention Type: DRUG

Other Intervention Names

Oral vancomycin; vancomycin

Eligibility Criteria

Inclusion Criteria

• "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

Exclusion Criteria

• Failure to meet all three requirements for "high risk"
• Vancomycin allergy
• Active clostridium difficile infection prior to inclusion
• Prophylactic oral vancomycin prior to study inclusion (i.e. prolonged vancomycin taper)
• Receipt of medications that also treat Clostridium difficile (metronidazole, rifaximin, fidaxomicin)
• Pregnant or breastfeeding

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Luke's Hospital, Chesterfield, Missouri

OTHER

Sponsor Role: lead

Responsible Party

Ryan Medas

PGY2 Pharmacy Internal Medicine Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan E Medas, PharmD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Hospital

References

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.

Reference Type: BACKGROUND

PMID: 25714160 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17926270 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20307191 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18177218 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24670166 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26113167 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27318333 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27358349 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

940920-2

Identifier Type: -

Identifier Source: org_study_id