Impact of Oral Antibiotic Treatment on C. Difficile

NCT02057198 | Completed Phase 4 Results

• 1 other identifier: Pro00043361
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim is to characterize and to compare the extent and quantity of C. difficile stool shedding, perianal colonization and environmental contamination in patients who received oral fidaxomicin, oral metronidazole, or oral vancomycin. This is a prospective, randomized, microbiologic and molecular, study of environmental contamination from patients with proven C. difficile associated diarrhea (CDAD).

Conditions

C. Difficile; Diarrhea; Enterocolitis

Outcome Measures

Primary Outcomes (1)

• Change in Total Median Total Colony Forming Units (CFU) of C. Difficile Identified in the Hospital Room Environment for Each Antibiotic Treatment Group.

  Rodac plates were used to take environmental samples from 5 different sites within each patient's hospital room (bedrail, overbed table, sink, toilet seat, bathroom floor). Each Rodac plate samples a surface area of \~25 cm2. 5 replicates were taken for each site and repeated on days 0, 3, 7, and 14. Median total colony counts are reported for each treatment group. Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.

  Days 0, 3, 7 and 14.

Secondary Outcomes (5)

• Total Environmental Contamination According to Antibiotic Treatment Group

  Days 0, 3, 7, and 14

• Molecular Relatedness of Isolates

  Days 0-14

• C. Difficile Shedding in Stool Over Time

  Days 0, 3, 7, 14

• Count of Stool Specimens From Patients That Are Positive for C. Difficile

  Days 0, 3, 7, 14

• Percentage of Stool Specimens From Patients That Are Positive for C. Difficile

  Days 0, 3, 7, 14

Study Arms (3)

Fidaxomicin

ACTIVE COMPARATOR

200 mg. 2 times a day for 10 days

Drug: Fidaxomicin

Metronidazole

ACTIVE COMPARATOR

500 mg.orally 3 times daily for 10 days

Drug: Metronidazole

Vancomycin

ACTIVE COMPARATOR

125 mg. orally 4 times a day for 10 days

Drug: Vancomycin

Interventions

Fidaxomicin DRUG

Also known as: Drug class(es): macrolides, Dificid

Fidaxomicin

Metronidazole DRUG

Also known as: Drug class(es): amebicides, Flagyl, Flagyl IV, Metro, Flagyl ER

Metronidazole

Vancomycin DRUG

Also known as: Drug Class:Glycopeptide antibiotics, Vancocin HCl Pulvules, Vancocin, Lyphocin, Vancocin HCl

Vancomycin

Eligibility Criteria

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

You may qualify if:

• adult patients with microbiology-proven CDAD
• provides informed consent
• eligible to receive oral antibiotic therapy

You may not qualify if:

• prisoners
• pregnant women
• children \<18 years
• patients who have contra-indications for perianal swabs, those who has medical conditions that would invalidate the results of the swabs
• patients requiring intravenous therapy for treatment of CDAD
• patients who do not consent and those who withdraw consent

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Turner NA, Warren BG, Gergen-Teague MF, Addison RM, Addison B, Rutala WA, Weber DJ, Sexton DJ, Anderson DJ. Impact of Oral Metronidazole, Vancomycin, and Fidaxomicin on Host Shedding and Environmental Contamination With Clostridioides difficile. Clin Infect Dis. 2022 Mar 1;74(4):648-656. doi: 10.1093/cid/ciab473.

  PMID: 34017999 DERIVED

MeSH Terms

Conditions

Diarrhea; Enterocolitis

Interventions

Fidaxomicin; Metronidazole; Benchmarking; Vancomycin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Polyketides; Macrocyclic Compounds; Polycyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Management Audit; Organization and Administration; Health Services Administration; Program Evaluation; Quality of Health Care; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Daniel Sexton, M.D.
• Organization: Duke University Medical Center

sexto002@mc.duke.edu

919-684-4596

Study Officials

• Daniel J Sexton, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: February 6, 2014
• Study Start: June 10, 2014
• Primary Completion: June 27, 2017
• Study Completion: June 27, 2017
• Last Updated: October 2, 2019
• Results First Posted: October 2, 2019

Record last verified: 2019-09

Locations

US (1)