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Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin

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ClinicalTrials.gov Identifier: NCT01818141
Recruitment Status : Completed
First Posted : March 26, 2013
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Collaborator:
Optimer Pharmaceuticals LLC
Information provided by (Responsible Party):
Hartford Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Clostridium Difficile Infection
Interventions Drug: Vancomycin
Drug: Fidaxomicin
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fidaxomicin Vancomycin
Hide Arm/Group Description

Fidaxomicin 200mg by mouth every 12 hours for 10 days

Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days

Vancomycin 125mg by mouth every 6 hours for 10 days

Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days

Period Title: Overall Study
Started 18 16
Completed 15 13
Not Completed 3 3
Reason Not Completed
Withdrawal by Subject             2             0
No baseline C.diff colonies             1             1
Lost to Follow-up             0             2
Arm/Group Title Fidaxomicin Vancomycin Total
Hide Arm/Group Description

Fidaxomicin 200mg by mouth every 12 hours for 10 days

Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days

Vancomycin 125mg by mouth every 6 hours for 10 days

Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days

Total of all reporting groups
Overall Number of Baseline Participants 18 16 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 16 participants 34 participants
69  (15) 66  (15) 67  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Female
11
  61.1%
9
  56.3%
20
  58.8%
Male
7
  38.9%
7
  43.8%
14
  41.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.6%
1
   6.3%
2
   5.9%
White
16
  88.9%
15
  93.8%
31
  91.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   5.6%
0
   0.0%
1
   2.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 16 participants 34 participants
18 16 34
Baseline total colony forming units (CFU)   [1] 
Mean (Standard Deviation)
Unit of measure:  Log10 CFU/g stool
Number Analyzed 18 participants 16 participants 34 participants
5.41  (1.72) 4.96  (1.81) 5.19  (1.80)
[1]
Measure Description: Total colony forming units (CFU) of Clostridium difficile per patient at baseline. This is the addition of vegetative cell counts and spore cell counts.
Baseline spores CFU   [1] 
Mean (Standard Deviation)
Unit of measure:  Log10 CFU/g stool
Number Analyzed 18 participants 16 participants 34 participants
5.00  (1.44) 4.87  (1.43) 4.94  (1.47)
[1]
Measure Description: The count (colony forming units, CFU) of Clostridium difficile spores at baseline stool.
Baseline vegetative cells CFU   [1] 
Mean (Standard Deviation)
Unit of measure:  Log10 CFU/g stool
Number Analyzed 18 participants 16 participants 34 participants
4.23  (2.39) 4.22  (2.1) 4.23  (2.30)
[1]
Measure Description: Count (colony forming units, CFU) of vegetative Clostridium difficile in baseline stool.
1.Primary Outcome
Title C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool
Hide Description The number and percentage of patients who achieved at least 2 log10 colony forming units (CFU)/g of stool reductions of Clostridium difficile spores from baseline by the end of therapy (days 10-13).
Time Frame day 10-13
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fidaxomicin Vancomycin
Hide Arm/Group Description:

Fidaxomicin 200mg by mouth every 12 hours for 10 days

Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days

Vancomycin 125mg by mouth every 6 hours for 10 days

Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days

Overall Number of Participants Analyzed 12 9
Measure Type: Count of Participants
Unit of Measure: Participants
11
  91.7%
6
  66.7%
2.Primary Outcome
Title C. Difficile Vegetative Cell Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool
Hide Description The number and percentage of patients who achieved at least 2 log10 CFU/g of stool reductions of Clostridium difficile vegetative cells from baseline by the end of therapy (days 10-13)
Time Frame day 10-13
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fidaxomicin Vancomycin
Hide Arm/Group Description:

Fidaxomicin 200mg by mouth every 12 hours for 10 days

Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days

Vancomycin 125mg by mouth every 6 hours for 10 days

Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days

Overall Number of Participants Analyzed 7 5
Measure Type: Count of Participants
Unit of Measure: Participants
4
  57.1%
5
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fidaxomicin Vancomycin
Hide Arm/Group Description

Fidaxomicin 200mg by mouth every 12 hours for 10 days

Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days

Vancomycin 125mg by mouth every 6 hours for 10 days

Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days

All-Cause Mortality
Fidaxomicin Vancomycin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fidaxomicin Vancomycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fidaxomicin Vancomycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%) 
Certain Agreements
Principal Investigators are NOT 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.
Results Point of Contact
Name/Title: Dr. David P. Nicolau, PharmD, FCCP, FIDSA
Organization: Hartford Hospital
Phone: 860-972-3941
Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01818141     History of Changes
Other Study ID Numbers: NICO003785HE
First Submitted: March 19, 2013
First Posted: March 26, 2013
Results First Submitted: February 28, 2017
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017