CompletedNot Applicable

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

United States10 participantsStarted 2011-07

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile

Timeframe: day 3 of treatment

Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates

Timeframe: day 1 stool sample

Mean (SD) Serum Tigecycline Concentration Level

Timeframe: day 3 of tigecycline therapy

Mean (SD) Stool Tigecycline Concentration Level

Timeframe: day 3 of tigecycline therapy

Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile

Timeframe: day 3 of treatment

Trial details

NCT IDNCT01401023

SponsorGary E. Stein, Pharm.D.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-07

Results submitted2013-07-30

View on ClinicalTrials.gov More Diarrhea trials