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NCT Number: NCT01401023

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

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).

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Key information

Conditions

Diarrhea Clostridium Difficile Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michigan State University, East Lansing, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tigecycline

Drug

: 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.

Other names: Tygacil

Primary outcomes

  1. Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile

    Time frame: day 3 of treatment

    Serum levels of tigecycline

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

    Time frame: day 1 stool sample

  3. Mean (SD) Serum Tigecycline Concentration Level

    Time frame: day 3 of tigecycline therapy

    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.

  4. Mean (SD) Stool Tigecycline Concentration Level

    Time frame: day 3 of tigecycline therapy

    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

  5. Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile

    Time frame: day 3 of treatment

    Stool levels of tigecycline

Sponsors and collaborators

Lead sponsor

Gary E. Stein, Pharm.D.

Other

Collaborators

  • Pfizer

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 25, 2011
Registry last updated
Jul 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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