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

Gary E. Stein, Pharm.D.

Status: Completed

Conditions: Diarrhea; Clostridium Difficile

Treatments: Drug: Tigecycline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01401023

WS1481739

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Clostridium difficile Patient

Experimental group

Description:

Open non-comparative trial

Treatment:

Drug: Tigecycline