NCT01818141

Brief Summary

The purpose of this study is to compare number of vegetative cells and spores in stool over time for fidaxomicin or vancomycin in patients diagnosed with their first episode of C. difficile infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2014

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

June 28, 2017

Completed
Last Updated

June 28, 2017

Status Verified

May 1, 2017

Enrollment Period

2.2 years

First QC Date

March 19, 2013

Results QC Date

February 28, 2017

Last Update Submit

May 26, 2017

Conditions

Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (2)

  • C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool

    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).

    day 10-13

  • C. Difficile Vegetative Cell Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool

    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)

    day 10-13

Study Arms (2)

Fidaxomicin

ACTIVE COMPARATOR

Fidaxomicin 200mg by mouth every 12 hours for 10 days

Drug: Fidaxomicin

Vancomycin

ACTIVE COMPARATOR

Vancomycin 125mg by mouth every 6 hours for 10 days

Drug: Vancomycin

Interventions

VancomycinDRUG

Vancomycin 125mg by mouth every 6 hours for 10 days

Also known as: Vancomycin 125mg by mouth every 6 hours for 10 days
Vancomycin
FidaxomicinDRUG

Fidaxomicin 200mg by mouth every 12 hours for 10 days

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and above
  • First diagnosis of C. difficile infection
  • Treatment for C. difficile infection less than 24 hours
  • Female subjects must be nonpregnant, nonlactating, and either postmenopausal for at least 1 year, surgically sterile (i.e., documented tubal ligation or hysterectomy) for at least 90 days, abstinent, or agree to use 1 of the following forms of contraception from the time of signing the Informed Consent form (ICF) until 30 days after leaving the study site: a nonhormonal intrauterine device (IUD) with spermicide, female condom with spermicide, contraceptive sponge with spermicide, diaphragm with spermicide, cervical cap with spermicide, a male sexual partner who agrees to use a male condom with spermicide, or a sterile sexual partner.

You may not qualify if:

  • History of hypersensitivity to fidaxomicin or vancomycin
  • Pregnant or breast-feeding
  • Active treatment with other therapies with activity against C. difficile
  • Receiving any peristaltic agents
  • Medical history including ulcerative colitis or Chron's disease
  • Ordered to be nothing by mouth or cannot swallow the study medication
  • Participation in another clinical research study utilizing pharmacological treatment within 1 month or five half-lives of the medication whichever is longer
  • Any other reason felt by the investigator to potentially affect the outcomes of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Related Publications (1)

  • Housman ST, Thabit AK, Kuti JL, Quintiliani R, Nicolau DP. Assessment of Clostridium difficile Burden in Patients Over Time With First Episode Infection Following Fidaxomicin or Vancomycin. Infect Control Hosp Epidemiol. 2016 Feb;37(2):215-8. doi: 10.1017/ice.2015.270. Epub 2015 Nov 23.

    PMID: 26592763RESULT

MeSH Terms

Conditions

Clostridium Infections

Interventions

VancomycinFidaxomicin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsMacrolidesLactonesOrganic ChemicalsPolyketidesMacrocyclic CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. David P. Nicolau, PharmD, FCCP, FIDSA
Organization
Hartford Hospital
david.nicolau@hhchealth.org
860-972-3941

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open-label
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2013

First Posted

March 26, 2013

Study Start

October 17, 2012

Primary Completion

December 15, 2014

Study Completion

December 15, 2014

Last Updated

June 28, 2017

Results First Posted

June 28, 2017

Record last verified: 2017-05

Locations

US(1)