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NCT Number: NCT03466502

Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics

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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Key information

Conditions

Clostridium Difficile Infection Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Previous CDI diagnosis
  • Current admission with a suspected or a confirmed bacterial infection requiring antibiotics

Exclusion criteria

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

Treatment and study plan

Oral Vancomycin

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Nevada, Reno

Other

Collaborators

  • Renown Regional Medical Center

Registry information

Official study title

Efficacy of Prophylactic Oral Vancomycin in Preventing Recurrent Clostridium Difficile Infection in Hospitalized Patients Requiring Antibiotics

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 15, 2018
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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