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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000064-10-AT

Enrollment

Registered

2011-02-16

Start date

2011-03-17

Completion date

Unknown

Last updated

2013-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Zyvoxid Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Linezolid CAS Number: 165800-03-3 Other descriptive name: Linezolid Concentration unit: mg/ml mill

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Determination of concentrations of linezolid or tigecycline in plasma, the ductus of infected fistulas and superficial skin after tigecycline or linezolid administration. Tissue concentrations will be related to corresponding unbound plasma concentrations. ;Secondary Objective: Calculation of PK/PD indices to estimate target site efficacy of linezolid or tigecycline. ;Primary end point(s): Area under the concentration time curve (AUC), maximum concentration (Cmax), half-life (t1/2), time of maximum concentration (tmax).	—

Measure

Time frame

Main Objective: Determination of concentrations of linezolid or tigecycline in plasma, the ductus of infected fistulas and superficial skin after tigecycline or linezolid administration. Tissue concentrations will be related to corresponding unbound plasma concentrations. ;Secondary Objective: Calculation of PK/PD indices to estimate target site efficacy of linezolid or tigecycline. ;Primary end point(s): Area under the concentration time curve (AUC), maximum concentration (Cmax), half-life (t1/2), time of maximum concentration (tmax).

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026