Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)
| Status: | Completed |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/12/2018 |
| Start Date: | July 2011 |
| End Date: | July 2013 |
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).
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).
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.
Patients will then be observed for clinical outcomes and relapse of CDAD.
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.
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials