Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection

NCT02237859 | Unknown Phase 4

• 2 other identifiers: 2013-303DDI.FY14.01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

We are doing this research study to determine if taking vancomycin in addition to a broad-spectrum antibiotic will decrease the chance of developing recurrent Clostridium difficile infection.

Conditions

Clostridium Difficile Infection

Keywords

cdiff; vancomycin; infection; clostridium difficile

Outcome Measures

Primary Outcomes (1)

• The incidence of recurrent Clostridium difficile infection

  2 years

Study Arms (1)

Vancomycin

EXPERIMENTAL

Vancomycin 125 mg PO QD vs Placebo

Drug: Vancomycin; Dietary Supplement: fruit juice/placebo

Interventions

Vancomycin DRUG

Vancomycin Group: Study participants started on a broad-spectrum antibiotic will be initiated on Vancomycin 125 mg PO QD within 48 hrs of the 1st dose of primary broad-spectrum antibiotic and continued to complete a 10 day course regardless of the duration of primary antibiotic. Dose of oral Vancomycin is 125 mg PO QD. Vancomycin liquid will be dissolved in fruit juice which is standard practice at Spectrum Health Hospitals. Both groups will continue in the study even if their broad spectrum antibiotic therapy is curtailed prior to 10 days.

Vancomycin

fruit juice/placebo DIETARY_SUPPLEMENT

Placebo Group: Will receive similar volume of fruit juice/placebo for 10 days.

Vancomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In patients \>19 years of age
• History of C. difficile diarrhea within 16 weeks and treated with Flagyl or Vancomycin during last episode.
• Patients started on antibiotics during current admission for any other indication at any point of time during hospital course.

You may not qualify if:

• Current diagnosis of CDI
• First episode of CDI during this admission.
• Allergy to Vancomycin or other known intolerance
• Pregnant
• h) Patient has received broad-spectrum antibiotics for more than 48 hours for this admission j) Incarceration

Sponsors & Collaborators

• Corewell Health West: lead

Study Sites (1)

Spectrum Health Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

MeSH Terms

Conditions

Clostridium Infections; Infections

Interventions

Vancomycin; Fruit and Vegetable Juices

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Andrew Maternowski, MD

  Corewell Health West

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 11, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 11, 2014

Record last verified: 2014-09

Locations

US (1)