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Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics

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ClinicalTrials.gov Identifier: NCT03466502
Recruitment Status : Enrolling by invitation
First Posted : March 15, 2018
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Renown Regional Medical Center
Information provided by (Responsible Party):
Lauren Zion, PharmD, University of Nevada, Reno

Brief Summary:
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 or disease Intervention/treatment Phase
Clostridium Difficile Infection Drug: Oral Vancomycin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. Time between recurrent CDI and the last C diff infection [ Time Frame: During hospitalization or the 12 weeks after therapy ]
  3. 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

  4. 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 ]
  5. Rate of reported adverse events [ Time Frame: During hospitalization or the 12 weeks after therapy ]
  6. Mortality rate [ Time Frame: During hospitalization or the 12 weeks after therapy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466502


Locations
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United States, Nevada
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Sponsors and Collaborators
University of Nevada, Reno
Renown Regional Medical Center
Investigators
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Principal Investigator: Lauren Zion, PharmD Renown Regional Medical Center

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Responsible Party: Lauren Zion, PharmD, Pharmacist, University of Nevada, Reno
ClinicalTrials.gov Identifier: NCT03466502     History of Changes
Other Study ID Numbers: 1129396
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Infection
Communicable Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Vancomycin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents