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

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ClinicalTrials.gov Identifier: NCT01401023
Recruitment Status : Completed
First Posted : July 25, 2011
Results First Posted : October 14, 2013
Last Update Posted : October 14, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment
Diarrhea Clostridium Difficile Drug: Tigecycline

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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)
Study Start Date : July 2011
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Tigecycline
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

  2. Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates [ Time Frame: day 1 stool sample ]
  3. 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.

  4. 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


Eligibility Criteria

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 Posted: July 25, 2011    Key Record Dates
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