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Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01401023
First Posted: July 25, 2011
Last Update Posted: October 14, 2015
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.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Gary E. Stein, Pharm.D., Michigan State University
  Purpose
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).

Condition Intervention
Diarrhea Clostridium Difficile Drug: Tigecycline

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)

Resource links provided by NLM:


Further study details as provided by Gary E. Stein, Pharm.D., Michigan State University:

Primary Outcome Measures:
  • Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile [ Time Frame: day 3 of treatment ]
    Serum and stool levels of tigecycline

  • Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates [ Time Frame: day 1 stool sample ]
  • Mean (SD) Serum Tigecycline Concentration Level [ Time Frame: day 3 of tigecycline therapy ]
    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 [ Time Frame: day 3 of tigecycline therapy ]
    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


Enrollment: 10
Study Start Date: July 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clostridium difficile Patient
Open non-comparative trial
Drug: Tigecycline
: 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.
Other Name: Tygacil

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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): NCT01401023


Locations
United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
Sparrow Hosptial
Lansing, Michigan, United States, 48912
Sponsors and Collaborators
Gary E. Stein, Pharm.D.
Pfizer
Investigators
Principal Investigator: Gary Stein, PharmD Michigan State University
  More Information

Responsible Party: Gary E. Stein, Pharm.D., Professor of Medicine and Pharmacology, Michigan State University
ClinicalTrials.gov Identifier: NCT01401023     History of Changes
Other Study ID Numbers: WS1481739
First Submitted: June 16, 2011
First Posted: July 25, 2011
Results First Submitted: July 30, 2013
Results First Posted: October 14, 2013
Last Update Posted: October 14, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Tigecycline
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents