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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Gary E. Stein, Pharm.D., Michigan State University
ClinicalTrials.gov Identifier:
NCT01401023
First received: June 16, 2011
Last updated: October 15, 2013
Last verified: October 2013
  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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 Michigan State University:

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

  • Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates [ Time Frame: day 1 stool sample ] [ Designated as safety issue: No ]
  • Mean (SD) Serum Tigecycline Concentration Level [ Time Frame: day 3 of tigecycline therapy ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 16, 2011
Results First Received: July 30, 2013
Last Updated: October 15, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 28, 2014