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

Not Applicable

Completed

• Conditions: Diarrhea; Clostridium Difficile
• Interventions: Drug: Tigecycline

• Registration Number: NCT01401023
• Lead Sponsor: Gary E. Stein, Pharm.D.

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).

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 Timeline

• Study First Submitted: 2011-06-16
• Study Start: 2011-07
• Study First Submitted QC: 2011-07-21
• Study First Posted: 2011-07-25
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2013-07-30
• Results First Submitted QC: 2013-07-30
• Results First Posted: 2013-10-14
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-14
• Last Update Posted: 2018-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clostridium difficile Patient	Tigecycline	Open non-comparative trial

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile	day 3 of treatment	Stool levels of tigecycline
Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates	day 1 stool sample
Mean (SD) Stool Tigecycline Concentration Level	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
Mean (SD) Serum Tigecycline Concentration Level	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.

Trial Locations

Locations (2)

Michigan State University; 🇺🇸 East Lansing, Michigan, United States

Sparrow Hosptial; 🇺🇸 Lansing, Michigan, United States