Back to resultsPharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)
Primary Purpose
Diarrhea, Clostridium Difficile
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tigecycline
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea
Eligibility Criteria
Inclusion Criteria:
- non pregnant adults (≥18 years old) with a diagnosis of mild to severe CDAD (initial or recurrent) by positive C. difficile toxin assay along with clinical symptoms (watery stools, fever, abdominal pain). Patients will receive a minimum of 3 days of tigecycline.
Exclusion Criteria:
- pregnant patients
- allergy to tetracycline (or tigecycline) antibiotics or patients with life-threatening illness.
Sites / Locations
- Michigan State University
- Sparrow Hosptial
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Clostridium difficile Patient
Arm Description
Open non-comparative trial
Outcomes
Primary Outcome Measures
Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile
Serum levels of tigecycline
Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates
Mean (SD) Serum Tigecycline Concentration Level
Blood samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Serum concentrations were determined with the use of a validated high-performance liquid chromatography assay.
Mean (SD) Stool Tigecycline Concentration Level
Fecal samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Fecal concentrations were determined with the use of a validated high-performance liquid chromatography assay
Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile
Stool levels of tigecycline
Secondary Outcome Measures
Full Information
NCT ID
NCT01401023
First Posted
June 16, 2011
Last Updated
June 14, 2018
Sponsor
Gary E. Stein, Pharm.D.
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01401023
Brief Title
Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)
Official Title
Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gary E. Stein, Pharm.D.
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective, non-comparative, interventional, observational pilot study of the safety and pharmacokinetics of intravenous (IV) tigecycline in conjunction with standard oral therapy in patients with known mild to severe confirmed Clostridium difficile associated diarrhea (CDAD).
Detailed Description
The intervention is adding Tigecycline (standard doses) to standard oral therapy for CDAD. Patients will then be observed for clinical outcomes and relapse of CDAD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Clostridium Difficile
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clostridium difficile Patient
Arm Type
Experimental
Arm Description
Open non-comparative trial
Intervention Type
Drug
Intervention Name(s)
Tigecycline
Other Intervention Name(s)
Tygacil
Intervention Description
: Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 milligram loading dose followed by 50 milligrams every 12 hours) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy.
Primary Outcome Measure Information:
Title
Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile
Description
Serum levels of tigecycline
Time Frame
day 3 of treatment
Title
Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates
Time Frame
day 1 stool sample
Title
Mean (SD) Serum Tigecycline Concentration Level
Description
Blood samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Serum concentrations were determined with the use of a validated high-performance liquid chromatography assay.
Time Frame
day 3 of tigecycline therapy
Title
Mean (SD) Stool Tigecycline Concentration Level
Description
Fecal samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Fecal concentrations were determined with the use of a validated high-performance liquid chromatography assay
Time Frame
day 3 of tigecycline therapy
Title
Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile
Description
Stool levels of tigecycline
Time Frame
day 3 of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
non pregnant adults (≥18 years old) with a diagnosis of mild to severe CDAD (initial or recurrent) by positive C. difficile toxin assay along with clinical symptoms (watery stools, fever, abdominal pain). Patients will receive a minimum of 3 days of tigecycline.
Exclusion Criteria:
pregnant patients
allergy to tetracycline (or tigecycline) antibiotics or patients with life-threatening illness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Stein, PharmD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Sparrow Hosptial
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)
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