Status:
COMPLETED
Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)
Lead Sponsor:
Gary E. Stein, Pharm.D.
Collaborating Sponsors:
Pfizer
Conditions:
Diarrhea
Clostridium Difficile
Eligibility:
All Genders
18+ years
Phase:
NA
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 patien...
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.
Eligibility Criteria
Inclusion
- 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
- pregnant patients
- allergy to tetracycline (or tigecycline) antibiotics or patients with life-threatening illness.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01401023
Start Date
July 1 2011
End Date
July 1 2013
Last Update
July 10 2018
Active Locations (2)
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1
Michigan State University
East Lansing, Michigan, United States, 48824
2
Sparrow Hosptial
Lansing, Michigan, United States, 48912