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

Gary E. Stein, Pharm.D.10 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diarrhea Clostridium Difficile

Interventions

TigecyclineDRUG

: 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Michigan State University

East Lansing, Michigan, United States

Sparrow Hosptial

Lansing, Michigan, United States

Outcomes

Primary Outcomes

Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile

Serum levels of tigecycline

Time frame: day 3 of treatment

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

Time frame: 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.

Time frame: 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

Time frame: day 3 of tigecycline therapy

Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile

Stool levels of tigecycline

Time frame: day 3 of treatment

Data from ClinicalTrials.gov

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