N/A
N=10
Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)
Diarrhea · Clostridium Difficile
Bottom Line
View on ClinicalTrials.gov: NCT01401023 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Oct 2013
Primary outcome: Primary: Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile — 0.18 milligrams/liter
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tigecycline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gary E. Stein, Pharm.D.
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile |
17.8 | — |
| PRIMARY Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates |
0.15 | — |
| PRIMARY Mean (SD) Serum Tigecycline Concentration Level |
0.18 | — |
| PRIMARY Mean (SD) Stool Tigecycline Concentration Level |
17.8 | — |
| PRIMARY Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile |
17.8 | — |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01401023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.