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

Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401023
• Other study ID #: WS1481739
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: July 2013

Study information

• Verified date: June 2018
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clostridium Difficile
• Diarrhea

Intervention

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.

Locations

Country	Name	City	State
United States	Michigan State University	East Lansing	Michigan
United States	Sparrow Hosptial	Lansing	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Gary E. Stein, Pharm.D.	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile	Serum levels of tigecycline	day 3 of treatment
Primary	Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates		day 1 stool sample
Primary	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
Primary	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
Primary	Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile	Stool levels of tigecycline	day 3 of treatment