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Use Of Oral Fidaxomicin Vs. Oral Vancomycin For Clostridium Difficile Infection In Patients With Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02355938
Recruitment Status : Terminated (Lost funding due to low enrollment.)
First Posted : February 4, 2015
Last Update Posted : October 13, 2016
Sponsor:
Collaborator:
Cubist Pharmaceuticals LLC
Information provided by (Responsible Party):
Rabih Darouiche, Baylor College of Medicine

Study Description
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Brief Summary:
The primary purpose of this study is to compare the clinical outcomes of cure and recurrence of Clostridium difficile infection in spinal cord injured patients who are treated with oral Fidaxomicin vs. oral Vancomycin. The secondary aim of this study is to compare the overall costs of treatment of Clostridium difficile infection in the two study groups.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Spinal Cord Injury Drug: Fidaxomicin 200 mg Drug: Placebo Drug: Vancomycin Phase 4

Detailed Description:
In recent clinical trials, comparing oral Vancomycin versus oral Fidaxomicin to treat Clostridium difficile, oral Fidaxomicin was shown to be the same in effectiveness as oral Vancomycin, but showed a decrease in recurrence of Clostridium difficile by ten percentage points. Based on experience with patients in our 40-bed spinal cord injury unit at the Michael E. DeBakey VA Medical Center (MEDVAMC), Clostridium difficile infection is more problematic in patients with spinal cord injury than in the general hospitalized patient population. Compared to the general population of hospitalized patients, patients with spinal cord injury are more likely to have: (1) a higher transmission of Clostridium difficile from one patient to another often via the health care worker due to their having a neurogenic bowel (2) a longer and more complicated course of Clostridium difficile infection-associated diarrhea since neurogenic bladder may delay excretion of toxins and predispose to bowel accidents; and (3) a higher overall cost of treatment in terms of extended hospitalization (most patients with spinal cord injury who suffer from Clostridium difficile infection do not get discharged from the hospital until the symptoms of course of Clostridium difficile infection are resolved. Fidaxomicin is the first in a new class of narrow spectrum macrocyclic antibiotic drugs. It is a non-systemic, meaning it is minimally absorbed into the bloodstream, and it is bactericidal, meaning it attacks and kills the bacteria it comes in contact with. It has demonstrated selective eradication of pathogenic Clostridium difficile with minimal disruption to the numerous species of bacteria that make up the normal, healthy intestinal flora. The maintenance of normal physiological conditions in the colon can reduce the probability of recurrence of a Clostridium difficile infection. Since clearance of Clostridium difficile infections is problematic in the spinal cord injured patients, this antimicrobial agent may show a trend for clinical superiority and a reduction in recurrence of infection within the spinal cord injury population resulting in a shorter hospital stays and reduced costs.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Role of Fidaxomicin in a Patient Population With Problematic Clostridium Difficile Infection
Study Start Date : February 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Fidaxomicin Arm
Oral Fidaxomicin 200 mg every 12 hours (Placebo for 2 doses) for 10 days
 Drug: Fidaxomicin 200 mg
Fidaxomicin 200 mg every 12 hours
Other Name: Dificid

Drug: Placebo
1 dose of placebo every 6 hours x 2 doses
Other Name: Cellulose Capsule
Active Comparator: Vancomycin Arm
Oral Vancomycin 125 mg every 6 hours for 10 days
 Drug: Vancomycin
Vancomycin 125 mg every 6 hours
Other Name: Vancocin


Outcome Measures
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Primary Outcome Measures :
  1. Cure of Clostridium Difficile [ Time Frame: 10 Days ]
    Decrease in number and frequency of loose stools


Secondary Outcome Measures :
  1. Cost Benefit Analysis [ Time Frame: Hospitalization cost 6 months before and 6 months after treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability of subject to provide an informed consent
  • Legally Authorized Representative-Adult must provide consent in case the subject is unable to consent
  • Diagnosis of Clostridium difficile disease based on clinical manifestations (change in bowel habits, at least 2 more unformed bowel movements as compared to baseline neurogenic bowel function in the same patient in the 24-hour period prior to randomization)
  • Lab data (positive polymerase chain reaction test for Clostridium difficile in a stool specimen obtained within 72 hours before randomization)
  • Patient has not received antibiotics that are active against Clostridium difficile for any more than 24 hours prior to being screened for this study.

Exclusion Criteria:

  • Receipt of agents (oral Vancomycin, oral or IV Metronidazole, oral rifamdin, oral bacitracin, or oral fusidic acid) that are active against Clostridium difficile for longer than 24 hours after randomization
  • Life-threatening or fulminant Clostridium difficile infection, presence of toxic megacolon, and history of inflammatory bowel disease (Crohn's disease and ulcerative colitis)
  • Allergy to study medications.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355938


Locations
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United States, Texas
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Cubist Pharmaceuticals LLC
Investigators
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Principal Investigator: Rabih O Darouiche, MD Michael E. DeBakey VA Medical Center
More Information
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Responsible Party: Rabih Darouiche, Medical Doctor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02355938    
Other Study ID Numbers: IIS-000116
H-32358 ( Other Identifier: Baylor College of Medicine )
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Enrollment to low for statistical analysis.
Additional relevant MeSH terms:
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Clostridium Infections
Spinal Cord Injuries
Infections
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
 Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Vancomycin
Fidaxomicin
Anti-Bacterial Agents
Anti-Infective Agents