Target site pharmacokinetics of linezolid or tigecycline in patients with severe skin and skin structure infections (SSSI) associated with chronic fistulas. - Fistula-SD-MD

• Conditions: The findings of the present study will enable assessing whether currently employed therapy regimens with linezolid or tigecycline provide effective antimicrobial concentrations at the target site of infected fistulas.

• Registration Number: EUCTR2011-000064-10-AT
• Lead Sponsor: Med. Univ. Wien, Klinik für klinische Pharmakologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-16
• Last Update Posted: 17 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

•Male or female, aged between 18 and 90 years
•Clinically diagnosis of chronic fistulas as caused by hidradenitis suppurativa or other chronic processes
•Willingness and ability to comply with the protocol
•Signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Allergy or hypersensitivity against study drug
•Contraindications for use of study drug
•Severe renal impairment Severe hepatic impairment (Child-Pugh Class C)
•Pregnancy, or women of child bearing potential not willing to apply adequate contraception during study period
•Any disease considered relevant for proper performance of the study or risks to the patient, at the discretion of the investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified