None listed
Conditions
Interventions
Group 1 Type of group
For initial IV administration, PTK 0796 is administered as 100 mg in ~ 110 ml (expected final volume) of sterile saline infused for 30 minutes every 24 hours. Then in oral administration, PTK 0796 is administered in the form of two 150 mg tablets every morning (300 mg PO every 24 hours)
Group name:Group 2 Type of group
In the first phase of administration IV Linezolid, 600 mg in 300 mL is applied every 24 hours. Then in the oral phase a 600 mg tablet is administered every morning on an empty stomach and a 600 mg tablet 12 hours after the morning dose, with or without food.
Sponsors
Paratek Pharmaceuticals, Inc.,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
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
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 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 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Analysis of adverse events and other safety measurements (eg, vital signs, laboratory analysis) using descriptive statistical methods and graphs. The AEs will be classified using the MedDRA system; Concomitant medications will be classified using the World Health Organization Drug Dictionary (WHO) and the ingredients will be classified using the Anatomical-Therapeutic-Chemical (ATC) Level III system. Measure:Safety of the study medication Timepoints:4 weeks ; Outcome name:It will be assessed through the analysis of the PK population of subjects in this study to assess the impact of demographic data (e.g., weight, BSA, sex, race, ethnicity) and clinical factors (e.g., co-illnesses). morbid, renal and hepatic function) on drug exposure. Measure:Changes in AUC (0-24) for PTK 0796; the Cmax and t1 / 2 apparent Timepoints:Week 4 | — |
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Subjects will be considered an Assessable Clinical Success if they meet all of the following criteria: • Do not meet any criteria for the Assessable Clinical Failure; • They did not receive potentially effective out-of-study antibiotics for any other reason; • In the evaluation of the Cure Test, the Blind Evaluator indicates that the infection had resolved sufficiently so that no antibiotics were needed. The population with Modified Intention to Treat (MITT) comprises all subjects in the ITT population who have an isolated Infectious Pathogen at the Baseline Visit. The Clinically Assessable Population (EC) comprises all subjects in the ITT population that meet the specific criteria so that the clinical outcome of their infection could be inferred to reflect the effect of the study drug. Measure:Clinical success in populations with Modified Intention to Treat (MITT) and Evaluable Clinic (EC) Timepoints:4 weeks | — |
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed