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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Diarrhea, Clostridium Difficile

Intervention / Treatment
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* Drug: Tigecycline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clostridium difficile Patient<br>Open non-comparative trial | Drug: Tigecycline<br>* : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 milligram loading dose followed by 50 milligrams every 12 hours) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy.<br>* Other names: Tygacil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile | Serum levels of tigecycline | day 3 of treatment | 
| Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates |  | day 1 stool sample | 
| Mean (SD) Serum Tigecycline Concentration Level | Blood samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Serum concentrations were determined with the use of a validated high-performance liquid chromatography assay. | day 3 of tigecycline therapy | 
| Mean (SD) Stool Tigecycline Concentration Level | Fecal samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Fecal concentrations were determined with the use of a validated high-performance liquid chromatography assay | day 3 of tigecycline therapy | 
| Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile | Stool levels of tigecycline | day 3 of treatment |