C-Diff: Impact of Oral Antibiotic Treatment on C. Difficile

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02057198
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 3
• Actual Duration (Months): 36.6
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
C. Difficile; Diarrhea; Enterocolitis	Drug: Fidaxomicin; Drug: Metronidazole; Drug: Vancomycin	Phase 4

Detailed Description

Background and Significance:

1. 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 analysis of 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 1) determine the impact of oral fidaxomicin, oral metronidazole and oral vancomycin on the baseline and the temporal variation of C. difficile isolated from specific body sites of a patient with microbiology-proven CDAD and 2) determine the impact of oral fidaxomicin, oral metronidazole and oral vancomycin on the baseline and the temporal variation of C. difficile isolated from targeted surfaces in a hospital room. , More specifically, we will establish the extent and quantity of C. difficile shedding, colonization and environmental contamination in patients who received oral fidaxomicin, oral metronidazole, or vancomycin and the duration that stool remains positive for C. difficile.

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 a randomized, controlled study of patients with documented CDAD, defined as having polymerase chain reaction 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 be block-randomized to receive one of the three antibiotic treatments for CDAD described above. 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 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 following randomization. Fidaxomicin will be supplied by the study sponsor. Metronidazole and vancomycin will not be supplied by the sponsor. If the subject is randomized to receive 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 typically 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. Each of three agents is recommended for the treatment of CDAD. Second, 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

1. difficile.

Data Analysis and Statistical Considerations:

Descriptive statistics will 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 10, 2014
• Actual Primary Completion Date: Jun 27, 2017
• Actual Study Completion Date: Jun 27, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fidaxomicin 200 mg. 2 times a day for 10 days	Drug: Fidaxomicin; Other Names: Drug class(es): macrolides Dificid
Active Comparator: Metronidazole 500 mg.orally 3 times daily for 10 days	Drug: Metronidazole; Other Names: Drug class(es): amebicides Flagyl Flagyl IV Metro Flagyl ER
Active Comparator: Vancomycin 125 mg. orally 4 times a day for 10 days	Drug: Vancomycin; Other Names: Drug Class:Glycopeptide antibiotics Vancocin HCl Pulvules Vancocin Lyphocin Vancocin HCl

Outcome Measures

Primary Outcome Measures

1. Change in Total Median Total Colony Forming Units (CFU) of C. Difficile Identified in the Hospital Room Environment for Each Antibiotic Treatment Group. [Days 0, 3, 7 and 14.]

   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.

Secondary Outcome Measures

1. Total Environmental Contamination According to Antibiotic Treatment Group [Days 0, 3, 7, and 14]

   In addition to total colony counts over time, the investigators also assessed the proportion of positive cultures over time (from the 5 replicate Rodac plate samplings repeated at each of 5 sites within each patient room: bedrail, overbed table, sink, toilet seat and bathroom floor). The cumulative proportion of positive cultures (including days 0, 3, 7, 14) is reported according to each treatment group.

2. Molecular Relatedness of Isolates [Days 0-14]

   When sufficient growth was available to permit sub-culture and ribotyping, we conducted ribotyping of each patient's stool C. difficile isolate for comparison to isolates from the same patient's hospital environment. Reported is the total percent of hospital room environmental isolates that match the ribotyping of the associated patient's stool sample (there is no averaging).

3. C. Difficile Shedding in Stool Over Time [Days 0, 3, 7, 14]

   C. difficile was isolated and serially diluted to permit colony counts (CFU/g stool) over time for each patient.

4. Count of Stool Specimens From Patients That Are Positive for C. Difficile [Days 0, 3, 7, 14]

   Count of stool cultures positive for C. difficile at each time point

5. Percentage of Stool Specimens From Patients That Are Positive for C. Difficile [Days 0, 3, 7, 14]

   Percentage of stool cultures positive for C. difficile at each time point

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Daniel J Sexton, MD, Duke University

Study Documents (Full-Text)

• Study Protocol - Feb 28, 2019
• Statistical Analysis Plan - Oct 25, 2018

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02057198
• Other Study ID Numbers: Pro00043361
• First Posted: Feb 6, 2014
• Last Update Posted: Oct 2, 2019
• Last Verified: Sep 1, 2019

• Additional relevant MeSH terms: Enterocolitis; Diarrhea; Anti-Bacterial Agents; Metronidazole; Vancomycin; Fidaxomicin; Amebicides

Study Results

Participant Flow

Arm/Group Title	Fidaxomicin	Metronidazole	Vancomycin
Arm/Group Description	200 mg. 2 times a day for 10 days Fidaxomicin	500 mg.orally 3 times daily for 10 days Metronidazole	125 mg. orally 4 times a day for 10 days Vancomycin
Period Title: Overall Study
STARTED	11	11	11
COMPLETED	11	10	10
NOT COMPLETED	0	1	1

Baseline Characteristics

Arm/Group Title	Fidaxomicin	Metronidazole	Vancomycin	Total
Arm/Group Description	200 mg. 2 times a day for 10 days Fidaxomicin	500 mg.orally 3 times daily for 10 days Metronidazole	125 mg. orally 4 times a day for 10 days Vancomycin	Total of all reporting groups
Overall Participants	11	10	10	31
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.6 (22)	62.2 (15.1)	63.4 (9.6)	62 (16.1)
Sex: Female, Male (Count of Participants)
Female	4 36.4%	6 60%	5 50%	15 48.4%
Male	7 63.6%	4 40%	5 50%	16 51.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	11 100%	10 100%	10 100%	31 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	5 45.5%	5 50%	4 40%	14 45.2%
White	6 54.5%	5 50%	6 60%	17 54.8%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	11 100%	10 100%	10 100%	31 100%

Outcome Measures

1. Primary Outcome

Title	Change in Total Median Total Colony Forming Units (CFU) of C. Difficile Identified in the Hospital Room Environment for Each Antibiotic Treatment Group.
Description	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.
Time Frame	Days 0, 3, 7 and 14.

Outcome Measure Data

Analysis Population Description

Only completed participants were included in the analysis.

Arm/Group Title	Fidaxomicin	Metronidazole	Vancomycin
Arm/Group Description	200 mg. 2 times a day for 10 days Fidaxomicin	500 mg.orally 3 times daily for 10 days Metronidazole	125 mg. orally 4 times a day for 10 days Vancomycin
Measure Participants	11	10	10
Day 0	56	33	149
Day 3	7	53	24
Day 7	0	15	0
Day 14	0	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Metronidazole, Vancomycin
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.52
	Comments	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.
	Method	Mixed Models Analysis
	Comments	A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.15
	Confidence Interval	(2-Sided) 95%; -0.34 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fidaxomicin, Metronidazole
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.66
	Comments	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.
	Method	Mixed Models Analysis
	Comments	A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 95%; -0.69 to 0.35
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Total Environmental Contamination According to Antibiotic Treatment Group
Description	In addition to total colony counts over time, the investigators also assessed the proportion of positive cultures over time (from the 5 replicate Rodac plate samplings repeated at each of 5 sites within each patient room: bedrail, overbed table, sink, toilet seat and bathroom floor). The cumulative proportion of positive cultures (including days 0, 3, 7, 14) is reported according to each treatment group.
Time Frame	Days 0, 3, 7, and 14

Outcome Measure Data

Analysis Population Description

Only completed participants were included in the analysis.

Arm/Group Title	Fidaxomicin	Metronidazole	Vancomycin
Arm/Group Description	200 mg. 2 times a day for 10 days Fidaxomicin	500 mg.orally 3 times daily for 10 days Metronidazole	125 mg. orally 4 times a day for 10 days Vancomycin
Measure Participants	11	10	10
Measure Environmental cultures	794	575	774
Number [percentage of positive cultures]	13.4	18.6	7.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Metronidazole, Vancomycin
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi square (2 proportion test)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fidaxomicin, Metronidazole
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Chi square (2 proportion test)
	Comments

3. Secondary Outcome

Title	Molecular Relatedness of Isolates
Description	When sufficient growth was available to permit sub-culture and ribotyping, we conducted ribotyping of each patient's stool C. difficile isolate for comparison to isolates from the same patient's hospital environment. Reported is the total percent of hospital room environmental isolates that match the ribotyping of the associated patient's stool sample (there is no averaging).
Time Frame	Days 0-14

Outcome Measure Data

Analysis Population Description

Ribotyping could only be conducted in instances where sufficient growth occurred from both patient and environmental samples to permit subculture.

Arm/Group Title	Fidaxomicin	Metronidazole	Vancomycin
Arm/Group Description	200 mg. 2 times a day for 10 days Fidaxomicin	500 mg.orally 3 times daily for 10 days Metronidazole	125 mg. orally 4 times a day for 10 days Vancomycin
Measure Participants	3	4	4
Measure Environmental Isolates	22	25	9
Number [percent of matching isolates]	68.1	80.0	77.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Metronidazole, Vancomycin
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.99
	Comments
	Method	Chi square (2 proportion test)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fidaxomicin, Metronidazole
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.52
	Comments
	Method	Chi square (2 proportion test)
	Comments

4. Secondary Outcome

Title	C. Difficile Shedding in Stool Over Time
Description	C. difficile was isolated and serially diluted to permit colony counts (CFU/g stool) over time for each patient.
Time Frame	Days 0, 3, 7, 14

Outcome Measure Data

Analysis Population Description

Only completed participants were included in the analysis.

Arm/Group Title	Fidaxomicin	Metronidazole	Vancomycin
Arm/Group Description	200 mg. 2 times a day for 10 days Fidaxomicin	500 mg.orally 3 times daily for 10 days Metronidazole	125 mg. orally 4 times a day for 10 days Vancomycin
Measure Participants	11	10	10
Day 0	815940 (949503)	2233564 (3845558)	35340 (41612)
Day 3	72200 (156429)	1200 (283)	400 (693)
Day 7	0 (0)	0 (0)	0 (0)
Day 14	0 (0)	0 (0)	0 (0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Metronidazole, Vancomycin
	Comments	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. 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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Mixed Models Analysis
	Comments	A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.43
	Confidence Interval	(2-Sided) 95%; -0.67 to -0.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fidaxomicin, Metronidazole
	Comments	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. 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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Mixed Models Analysis
	Comments	A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.85
	Confidence Interval	(2-Sided) 95%; -1.14 to -0.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Count of Stool Specimens From Patients That Are Positive for C. Difficile
Description	Count of stool cultures positive for C. difficile at each time point
Time Frame	Days 0, 3, 7, 14

Outcome Measure Data

Analysis Population Description

Only completed participants were included in the analysis.

Arm/Group Title	Fidaxomicin	Metronidazole	Vancomycin
Arm/Group Description	200 mg. 2 times a day for 10 days Fidaxomicin	500 mg.orally 3 times daily for 10 days Metronidazole	125 mg. orally 4 times a day for 10 days Vancomycin
Measure Participants	11	10	10
Measure specimens	20	22	20
Day 0	20	21	17
Day 3	6	3	2
Day 7	0	0	0
Day 14	0	0	0

6. Secondary Outcome

Title	Percentage of Stool Specimens From Patients That Are Positive for C. Difficile
Description	Percentage of stool cultures positive for C. difficile at each time point
Time Frame	Days 0, 3, 7, 14

Outcome Measure Data

Analysis Population Description

Only completed participants were included in the analysis.

Arm/Group Title	Fidaxomicin	Metronidazole	Vancomycin
Arm/Group Description	200 mg. 2 times a day for 10 days Fidaxomicin	500 mg.orally 3 times daily for 10 days Metronidazole	125 mg. orally 4 times a day for 10 days Vancomycin
Measure Participants	11	10	10
Measure specimens	20	22	20
Day 0	100	95.5	85
Day 3	60	75	33
Day 7	0	0	0
Day 14	0	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Metronidazole, Vancomycin
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.48
	Comments
	Method	Chi square (two proportion test)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fidaxomicin, Metronidazole
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.66
	Comments
	Method	Chi square (two proportion test)
	Comments

Adverse Events

Time Frame	During of index hospital admission (estimated maximum of 4 weeks after enrollment).
Arm/Group Title	Fidaxomicin		Metronidazole		Vancomycin
Arm/Group Description	200 mg. 2 times a day for 10 days Fidaxomicin		500 mg.orally 3 times daily for 10 days Metronidazole		125 mg. orally 4 times a day for 10 days Vancomycin
All Cause Mortality
	Fidaxomicin		Metronidazole		Vancomycin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/11 (18.2%)		0/10 (0%)		2/10 (20%)
Serious Adverse Events
	Fidaxomicin		Metronidazole		Vancomycin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Fidaxomicin		Metronidazole		Vancomycin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.