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

NCT01401023 | Completed Results DMC

• 1 other identifier: WS1481739
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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).

Conditions

Diarrhea; Clostridium Difficile

Outcome Measures

Primary Outcomes (5)

• Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile

  Serum levels of tigecycline

  day 3 of treatment

• Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates

  day 1 stool sample

• 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.

  day 3 of tigecycline therapy

• 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

  day 3 of tigecycline therapy

• Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile

  Stool levels of tigecycline

  day 3 of treatment

Study Arms (1)

Clostridium difficile Patient

EXPERIMENTAL

Open non-comparative trial

Drug: Tigecycline

Interventions

Tigecycline DRUG

: 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.

Also known as: Tygacil

Clostridium difficile Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• pregnant patients
• allergy to tetracycline (or tigecycline) antibiotics or patients with life-threatening illness.

Sponsors & Collaborators

• Gary E. Stein, Pharm.D.: lead
• Pfizer: collaborator

Study Sites (2)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Sparrow Hosptial

Lansing, Michigan, 48912, United States

Location

MeSH Terms

Conditions

Diarrhea

Interventions

Tigecycline

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Gary Stein, Pharm D
• Organization: Michigan State University

steing@msu.edu

517-353-5126

Study Officials

• Gary Stein, PharmD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine and Pharmacology

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: July 25, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 10, 2018
• Results First Posted: October 14, 2013

Record last verified: 2018-06

Locations

US (2)