A Randomized, Evaluator-Blinded, Phase 3 Study to Compare the Safety and Efficacy of PTK 0796 With Linezolid in the Treatment of Adults With Complicated Skin and Skin Structure Infectio

Not Applicable

• Conditions: -L08; L08

• Registration Number: PER-045-09
• Lead Sponsor: Paratek Pharmaceuticals, Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-19
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

• 18 years of age or older;
• Provide informed consent signed and dated before carrying out any specific study procedure;
• Having a skin or skin structure infection that qualifies for the study (see Section 8.1);
• If you are male and sexually active with couples of reproductive age (see definition below) you must agree to use an effective method of birth control (contraception, see definition below) while receiving the study drug and for 30 days thereafter at the last dose with the study drug;
• If you are a woman and are sexually active, you must meet one of the following two criteria: (a) not be able to reproduce; or (b) meets both of the following criteria: Obtains a negative pregnancy test result (see Section 10.10.1) immediately before Enrollment; and Accept to continue with effective birth control while receiving the study drug and for 30 days after the last dose with the study drug.

Exclusion Criteria

• Is breastfeeding;
• It has been previously treated under this protocol;
• You have received an investigational drug during the month prior to Enrollment;
• You have a history of a previous allergic reaction to any tetracycline (eg, minocycline, doxycycline or tetracycline) or to linezolid;
• Has a body weight <40 kg (88 Ib) or> 150 kg (330 Ib);
• It is known to be positive for HIV-1 or HIV-2 and meets the CDC criteria for Acquired Immune Deficiency Syndrome (AIDS) (patients with unknown HIV status do not need to be tested);
• Has a life expectancy of less than three months;
• Has a history or clinical evidence of hepatic decompensation as demonstrated by any of the following conditions: varicose bleeding, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy;
• Requires hemodialysis or peritoneal dialysis;
• Has a calculated creatinine clearance of <30 mL / min, based on the most recent creatinine level (obtained within 5 days prior to enrollment) and the Cockcroft-Gault equation:
• You have received chemotherapy that is expected to result in an absolute neutrophil count <500 / uL within 14 days after enrollment;
• Has, despite adequate resuscitation with liquids, both of the following findings: Hypotension (supine systolic blood pressure <90 mmHg) and Perfusion abnormalities (eg lactic acidosis, urine output <20 ml / hr, status acutely altered mental);
• Requires pressures to maintain blood pressure and / or adequate tissue perfusion;
• You have an infection excluded from the skin and skin structure (see Section 8.2);
• You have a confirmed or suspected non-infectious skin disorder that could interfere with evaluations in this protocol (eg, severe eczema or psoriasis);
• Has an infectious pathogen that is known to be intermediate or resistant in vitro to linezolid and / or aztreonam;
• You have received, for any reason, a potentially effective systemic antibiotic for> 48 hours immediately before the first infusion with the study drug unless the infectious pathogen of the skin and the skin structure is intermediate or resistant in vitro to previous antibacterial treatment (eg treated with oxacillin and found to have methicillin-resistant S. aureus);
• Has any concomitant condition that, in the opinion of the Researcher, is likely to interfere with the evaluation of the infection response under study, the determination of adverse events, or the completion of the expected treatment cycle.

Study & Design

• Study Type: Interventional
• Study Design: Not specified