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

Completed · Not applicable

Conditions studied: Diarrhea, Clostridium Difficile

In brief

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).

Key facts

Study ID

NCT01401023

Run by

Gary E. Stein, Pharm.D.

People needed

10

Starts

2011-07-01

Expected to finish

2013-07-01

Last updated by the study team

2018-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Michigan State University — East Lansing, Michigan, United States
• Sparrow Hosptial — Lansing, Michigan, United States

Full record on ClinicalTrials.gov

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