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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gary E. Stein, Pharm.D.
• Collaborator: Pfizer
• Treatments: Minocycline; Tigecycline

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.