Clinical Trials

MainTitle

Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics

This study has been enrolling by invitation
Sponsor
University of Nevada, Reno

Collaborator
Renown Regional Medical Center

Information provided by (Responsible Party)
Lauren Zion, PharmD, University of Nevada, Reno

ClinicalTrials.gov Identifier
NCT03466502

First received: March 8, 2018
Last updated: September 27, 2019
Last Verified: September 2019
History of Changes
Purpose

Purpose

This study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent Clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection.

Condition Intervention Phase
Clostridium Difficile Infection

Drug : Oral Vancomycin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Prophylactic Oral Vancomycin in Preventing Recurrent Clostridium Difficile Infection in Hospitalized Patients Requiring Antibiotics

Further study details as provided by Lauren Zion, PharmD, University of Nevada, Reno:

Primary Outcome Measures

  • Recurrent Clostridium difficile infection [ Time Frame: During hospitalization or the 12 weeks after therapy ]
    Diarrheal illness, with at least 3 episodes of watery diarrhea over a 24 hour period and a positive toxin analysis or a positive PCR for Cdiff
Secondary Outcome Measures:
  • Recurrence rate of CDI according to C diff inducing properties of the prescribed antibiotics [ Time Frame: During hospitalization or the 12 weeks after therapy ]
    Low inducers: aminoglycosides, fosfomycin, glycopeptides, daptomycin, nitrofurantoin, linezolid, polymyxins, rifamycins, antifolates and/or sulfonamides, tetracyclines, tigecycline Moderate inducers: penicillins, 1st generation cephalosporins, macrolides, azithromycin, streptogramins High inducers: carbapenems, 2nd and greater generation cephalosporins, fluoroquinolones, clindamycin
  • Time between recurrent CDI and the last C diff infection [ Time Frame: During hospitalization or the 12 weeks after therapy ]
  • Rate of recurrence of CDI in immunocompromised patients [ Time Frame: During hospitalization or the 12 weeks after therapy ]
    HIV, Organ Transplantation, Current Immunosuppressive therapy, Hypogammaglobulinemia or steroids dose more than prednisone 20mg/day for 3 weeks
  • Rate of recurrence of CDI in patients with a history of the NAP-1 strain [ Time Frame: During hospitalization or the 12 weeks after therapy ]
  • Rate of reported adverse events [ Time Frame: During hospitalization or the 12 weeks after therapy ]
  • Mortality rate [ Time Frame: During hospitalization or the 12 weeks after therapy ]

Estimated Enrollment: 300
Study Start Date: March 8, 2018
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
No Intervention: No oral vancomycin

Experimental: Oral vancomycin 125 mg twice daily

Drug: Oral Vancomycin

Oral vancomycin will be given concurrently with antibiotics to hospitalized patients with a history of Clostridium difficile infection to prevent recurrence

Experimental: Oral vancomycin 125 mg daily

Drug: Oral Vancomycin

Oral vancomycin will be given concurrently with antibiotics to hospitalized patients with a history of Clostridium difficile infection to prevent recurrence

Detailed Description:

This study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent Clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

    1. Age ≥18 years
    2. Previous CDI diagnosis
    3. Current admission with a suspected or a confirmed bacterial infection requiring antibiotics


Exclusion Criteria:
    1. Active chronic diarrheal illness (eg, Crohn's disease, ulcerative colitis, short bowel syndrome)
    2. Previous adverse reactions to oral vancomycin
    3. Requiring metronidazole during hospitalization
    4. Known pregnancy
    5. Expected survival <72 hours
    6. Patients receiving antibiotics only for surgical prophylaxis
    7. Patients who received prophylactic oral vancomycin for the current antibiotic course
    prior to enrollment in the study

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03466502

Locations

United States, Nevada
Renown Regional Medical Center
Reno, Nevada, United States, 89502

Sponsors and Collaborators

University of Nevada, Reno
Renown Regional Medical Center

Investigators

Principal Investigator: Lauren Zion, PharmD Renown Regional Medical Center
More Information

More Information


Responsible Party: Lauren Zion, PharmD, Pharmacist, University of Nevada, Reno  
ClinicalTrials.gov Identifier: NCT03466502   History of Changes  
Other Study ID Numbers: 1129396  
Study First Received: March 8, 2018  
Last Updated: September 27, 2019  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  
Product Manufactured in and Exported from the U.S.: No  

Keywords provided by Lauren Zion, PharmD, University of Nevada, Reno:

vancomycin
Clostridium difficile
Clostridium difficile infection
Recurrent Clostridium difficile infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Clostridium Infections
Vancomycin

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.