Impact of Oral Antibiotic Treatment on C. Difficile
Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: C. Difficile; Diarrhea; Enterocolitis
Intervention: Fidaxomicin (Drug); Metronidazole (Drug); Vancomycin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Duke University Official(s) and/or principal investigator(s): Luke Chen, MBBS,MPH, Principal Investigator, Affiliation: Duke University
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 vs. oral metronidazole or oral vancomycin. This is a prospective,
observational microbiologic, molecular, and epidemiological cohort study of eligible room
and patients with proven C. difficile associated diarrhea (CDAD).
Clinical Details
Official title: Exploratory Study of Impact of Oral Metronidazole, Vancomycin and Fidaxomicin on the Extent and Quantity of Host Carriage and Environmental Contamination With C. Difficile
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Change in variation of the profile of C. difficile isolated from specific body sites of a patient with microbiology-proven CDADChange in variation in the profile of C. difficile isolated from targeted surfaces in a hospital Extent and quantity of C. difficile shedding, colonization and environmental contamination in patients who received oral fidaxomicin vs. oral metronidazole or vancomycin Duration of diarrhea that were positive for CDAD
Detailed description:
Background and Significance:
C. difficile has emerged as one of the most important pathogens that threaten the health and
quality of life for many populations. Data from different studies clearly indicate that
shedding of viable spores and subsequent contamination of environmental surfaces play an
important role in the transmission of C. difficile. We aim to perform an exploratory
analysis on the impact of different oral antibiotic therapy on microbiologic kinetics in
patients with C. difficile diarrhea, such as: shedding, colonization and environmental
contamination. We believe data from this study can inform whether drug therapies may be used
to interrupt disease transmission and to improve the infection control of C. difficile.
Purpose of the Study:
The purposes of this study are to describe the baseline and the temporal variation of the
profile of C. difficile isolated from specific body sites of a patient with
microbiology-proven CDAD, characterize the baseline and the temporal variation in the
profile of C. difficile isolated from targeted surfaces in a hospital room, determine the
impact of oral fidaxomicin, oral metronidazole and oral vancomycin on the above
relationships over time and specifically establish the extent and quantity of C. difficile
shedding, colonization and environmental contamination in patients who received oral
fidaxomicin vs. oral metronidazole or vancomycin and the duration of diarrhea that were
positive for CDAD.
This study will prospectively study the role of the environment in Healthcare Associated
Infections (HAIs) in the modern healthcare setting and will specifically address many
limitations of previous studies. The study will use modern diagnostic and molecular methods
to describe the microbiologic characteristics and concordance of cultures from the
environment and from patient, describe temporal variation and relationship in the
microbiologic profiles of cultures obtained from the environment and from the patient,
assess confounders such as hand hygiene and quality of cleaning, and provide longitudinal
follow up for subsequent outcomes.
This study will utilize microbiologic and molecular techniques to critically and
prospectively examine the impact of the environmental bioburden on the risk of colonization
and infection of hospitalized patients. Data from this study will provide novel, important
information regarding the true impact of the hospital environment on the acquisition and
spread of HAIs and Multi-Drug Resistant (MDR)-pathogens in hospitalized patients over time.
As such, data collected in this study may provide important information about the mechanisms
and relative frequency of how and when environmental sources of bacteria lead to
colonization and infection in hospitalized patients. These data may in turn stimulate or
justify the future development of novel preventive interventions.
Design and Procedures/Study Interventions:
This is an observational, longitudinal study of patients with documented CDAD, which is
defined as having polymerase chain reaction or EIA test for C. difficile in a patient with
more than 3 loose stools within 24 hours. Eligible patients for enrollment will be
identified by microbiology-driven alerts or by orders for contact isolation for C.
difficile. Study team will be alerted to approach the patient to provide information about
the study and to obtain informed consent.
This study will obtain microbiological cultures from 2 sources: 1) environmental surfaces in
the room and 2) body surfaces of the patient at predefined intervals starting the day of
enrol1ment. Cultures will be obtained on Day 1 (day of enrol1ment), Day 3 and Day 7
following admission to the room, at the end of each subsequent week (Day 14, Day 21, etc.),
and on the day of discharge from the hospital room. Microbiological cultures will be
obtained from the following body sites: perianal and stool specimens. Microbiological
cultures will be obtained from 5 high-touch environmental surfaces as outlined in the
protocol.
Selection of Subjects:
A total of 30 patients are anticipated to be enrolled in this study, 10 in each of the three
treatment arms. Patients will receive antibiotic therapy for CDAD according to their
physician's directions. The study will enroll 10 patients receiving metronidazole therapy,
10 patients receiving oral vancomycin therapy and 10 patients receiving oral fidaxomicin
therapy.
As soon as the PI or study coordinator finds that a patient has a positive c. difficile
result, the primary care provider (PCP) in hospital will be contacted to discuss the
patient. If the PCP agrees to allow potential enrollment, the PCP will be asked which drug
that he/she is planning to prescribe. The drug prescribed is chosen by the PCP. To be
eligible for the study, the patient must be prescribed fidaxomicin, metronidazole or
vancomycin. The PCP will introduce the study to the patient. If the patient indicates
willingness to participate, the PI or study coordinator will be introduced by the PCP or
another caregiver known to the patient. The informed consent process will take place if the
patient is interested in participating. The patient will be enrolled as a study subject if
all eligibility criteria are met. The PCP will formally prescribe fidaxomicin, metronidazole
or vancomycin. Fidaxomicin will be supplied by the study sponsor. Metronidazole and
vancomycin will not be supplied by the sponsor. If the subject is prescribed fidaxomicin,
the PI or study coordinator will notify the Duke Investigational Drug Service (IDS) that a
subject is enrolling and will order this drug through the IDS. As soon as the 10th subject
who is prescribed fidaxomicin enrolls, then enrollment will be closed to patients prescribed
fidaxomicin. Enrollment will be closed to subjects taking metronidazole and vancomycin as
soon as the 10th subject in each group is enrolled. The subject will begin treatment with
the medication prescribed by the PCP in hospital
No compensation is being offered for participation in this study.
Consent Process:
The consent process will be conducted by a study coordinator or the principal investigator.
This will occur in the patient's hospital room.
Subject's Capacity to Give Legally Effective Consent:
Subjects will need to be able to give consent to participate in this study.
Risk/Benefit Assessment:
The risks are minimal for this study. First, patients may experience adverse effects from
the antibiotics that they consent to receive as part of usual clinical care for CDAD.
Secondly, the microbiological samples that will be taken may cause some discomfort and minor
bleeding which will be discussed with the patient during the consenting process. Declining
to participate in the study will not affect the clinical care of the patient. Results of
study specimens will not be analyzed in real-time and will not be sent back to clinicians.
SAEs are not anticipated for this study. Any standard SAE events that may occur will be
reported to the manufacturer and to the IRB.
There is no direct benefit to the patient in the study. The sponsor will supply Fidaxomicin
if this is prescribed for a patient enrolled in the study. The data from this study may
prompt future studies that examine the use oral antibiotics to reduce the transmissibility
of C. difficile.
Data Analysis and Statistical Considerations:
Descriptive statistics would be used to correlate culture results from the environment and
the patient.
Data and Safety Monitoring PI will review and sign off on all adverse events or problems as
they occur and will submit reports of such events to the IRB in accordance with HRPP
policies and to the sponsor in accordance with the protocol.
Privacy, Data Storage and Confidentiality Privacy during swabbing shall be maintained by
swabbing the patient in the patient's room with the door closed as would be appropriate for
other patient care, using Universal Precautions. To ensure privacy the patient and
environmental samples will use an automatically generated ID and room number in place of
name, MRN or other personal identifiers.
Data collected by the study will be entered into secure Access databases. All connections to
the system, both external and internal, occur over encrypted channels. Access to components
of the system is role-based and can only be granted by administrators of the system. All
collected information is stored on a server hosted by Duke Medicine
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- adult patients with microbiology-proven CDAD
- provides informed consent
- eligible to receive oral antibiotic therapy
Exclusion Criteria:
- 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
Locations and Contacts
Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting Luke Chen, M.D., Phone: 919-681-5447, Email: luke.chen@dm.duke.edu Luke Chen, MBBS,MPH, Principal Investigator
Additional Information
Starting date: February 2014
Last updated: August 3, 2015
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