inezolid In The Treatment Of Complicated Skin And Soft Tissue Infections Proven To Be Due To Methicillin-Resistant Staphylococcus AureusLinezolid en el tratamiento de infecciones complicadas de piel y partes blandas causadas por Staphylococcus aureus resistente a meticilina

Phase 1

• Conditions: Complicated skin and soft tissue infections; Classification code 10049582

• Registration Number: EUCTR2004-001200-12-ES
• Lead Sponsor: Pfizer,S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-02
• Study Completion: 2007-07-24
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1.Hospitalized male and female subjects with signs or symptoms consistent with infection, and if available, laboratory findings consistent with staphylococcal infection (e.g., Gram stain and culture results)
2.Subject or his/her legally acceptable representative must give informed consent by signing and dating an informed consent form prior to study entry
3.Subjects must be at least 18 years of age
4.Women of childbearing potential must use adequate contraception, defined as hormonal contraception, intrauterine device, or barrier methods (condom or vaginal diaphragm) with spermacide, throughout the study. The pre-study pregnancy test (urine or serum gonadotropin) must be negative. Women who have been surgically sterilized or are at least two years postmenopausal may be enrolled and do not have to use birth control. Women whose method of birth control is hormonal are required to use an additional barrier method during the study.
5.Subjects must be hospitalized at time of randomization
6. Subjects must be expected to survive with effective antibiotic therapy and appropriate supportive care throughout the period of treatment and follow-up
7.Subjects must be willing to complete all study related activities
8.Subjects who, after control of their acute infection, are likely to be eligible to be discharged to outpatient therapy
9.Subjects must have at least two of the specific signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA that involves deep tissues such as subcutaneous tissue, fascia or skeletal muscle. Signs or symptoms may include:·purulent drainage·erythema ·swelling·induration·tenderness to palpation·pain·local warmth
10. Subjects should also have at least one of the following: ·elevated body temperature: (oral >38ºC/100.4ºF), (rectal >39ºC/102.2ºF), (axillary >37.5ºC/99.5ºF), (tympanically >38.5ºC/101.3ºF) that has occurred within the last six hours·hypotension:(systolic BP<90mmHg)·elevated total peripheral white blood cell count > 10,000/mm3 15% immature neutrophils (bands) regardless of total peripheral white count
11.Subjects must have venous access available for intravenous dosing
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)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subjects who have received an investigational drug during the previous 30 days or five times the plasma half-life (if known), whichever is longer or who have previously participated in this trial or any other protocol using linezolid
2.Subjects of childbearing potential, who are unable to take adequate contraceptive precautions, have a positive pregnancy test result within 24 hours prior to study entry, are otherwise known to be pregnant, or are currently breastfeeding an infant
3.Subjects with infected devices, where the device is not removed
4.Subjects with a hypersensitivity to vancomycin, oxazolidinones or any of the excipients in the IV or oral formulation of linezolid
5.Subjects with MRSA known to be resistant to either of the study drugs before study entry
6.Subjects who were treated with a previous antibiotic with MRSA activity for more than 24 hours, unless documented to be a treatment failure (72 hours of treatment and not responding). Certain drugs with variable MRSA activity (e.g. fluoroquinolones) may not be excluded if local susceptibility patterns will predict resistance and resistance is subsequently documented (see section 5.3)
7.Subjects who have received linezolid or vancomycin for more than 24 hours may not be enrolled
8.Subjects with necrotizing fasciitis, gas gangrene or osteomyelitis
9.Subjects with rapidly fatal underlying disease not expected to survive to complete the study
10.Subjects who have recent history of bone marrow transplant

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the clinical efficacy of linezolid to vancomycin in the treatment of complicated skin and soft tissue infections (cSSTI) due to MRSA in adult subjects hospitalized for at least one day at the End of Study (EOS) visit.;Secondary Objective: The secondary objective of this study is to compare the bacteriological efficacy and safety and tolerability of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalised adults.;Primary end point(s): The primary efficacy endpoint will be the clinical outcome at the EOS visit, in subjects with baseline MRSA.