Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01967225
Other study ID # 16099
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 23, 2013
Est. completion date October 28, 2016

Study information

Verified date September 2018
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to see the efficacy and safety of BAY1192631 in Japanese patients with methicillin-resistant staphylococcus aureus (MRSA) (skin and soft tissue infections (SSTI) and SSTI-related bacteremia).


Recruitment information / eligibility

Status Completed
Enrollment 125
Est. completion date October 28, 2016
Est. primary completion date October 28, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria

- Suspected or confirmed Methicillin-resistant Staphylococcus aureus (MRSA) infection

- Japanese Male and female patients aged 18 years or above

- Diagnosis of Skin and soft tissue infection with MRSA either suspected or confirmed as the major cause of infection, with/without SSTI (skin and soft tissue infection)-derived MRSA bacteremia suspected

Exclusion Criteria:

- Having received any systemic antibacterial potentially effective against MRSA for >/=24 hours within 3 days prior to the first infusion of a study drug, or having received/expected to receive the medication within 24 hours prior to the first infusion, unless antibacterial therapy for >/=72 hours proves to be ineffective on or lack appropriate potency (resistant) to MRSA.

- Moribund clinical condition such as death likely within the first 3 days of a study drug treatment

- History of significant allergy or intolerance to linezolid or BAY1192631

- Known or suspected human immunodeficiency virus (HIV) infection with a CD4+ T-cell count < 200/µL

- Chronic treatment with immunosuppressive drugs

- Active tuberculosis or non-tuberculous mycobacteriosis which need medical treatments

- Current or anticipated neutropenia with neutrophil count < 1,000/ mm^3

- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >/= 8 times the upper limit of reference range OR moderate to severe hepatic disease with Child Pugh score >/=10.

Study Design


Intervention

Drug:
Tedizolid Phosphate (Sivextro, BAY1192631)
BAY1192631 solution or tablet 200 mg, once daily, Intravenous (IV) or By Mouth (PO) for 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia.
Linezolid
Linezolid solution or tablet 600 mg, twice daily, every 12 ±3 hours, Intravenous (IV) or By mouth (PO) 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Response at Test of Cure (TOC) Clinical response was evaluated by the masked investigator as clinical cure, clinical failure and indeterminate on the basis of the clinical symptoms/findings, vital sign and laboratory data from screening period to each evaluation point. Measurements for the assessment of clinical response included body temperature, pulse/heart rate, respiration rate, and white blood cell or band cell count. 7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia
Primary Microbiological Response at Test of Cure (TOC) Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society. 7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia
Secondary Clinical Response at End of Treatment Visit (EOT) Clinical response was evaluated by the masked investigator as effective, ineffective and indeterminate on the basis of the clinical symptoms/findings, vital sign and laboratory data from screening period to each evaluation point. Measurements for the assessment of clinical response included body temperature, pulse/heart rate, respiration rate, and white blood cell or band cell count. 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration
Secondary Microbiological Response at End of Treatment (EOT) Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society. 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration
Secondary Change of the Lesion Size From the Screening Visit by Visit (Only Skin and Soft Tissue Infection [SSTI]) Lesion size was measured by the masked investigators of erythema, edema, or induration whichever is largest. Multiple time points up to 7-14 days after the end of treatment
Secondary Reduction Ratio of the Lesion Size From the Screening Visit to Day 3 to Day 4 Visit (Only Skin and Soft Tissue Infection [SSTI]) Lesion size was measured by the masked investigators of erythema, edema, or induration whichever is largest. Reduction ratio (%) = 100 * (the post baseline value - baseline value) / baseline value. Negative values represent reduction of lesion size compared to baseline. Baseline and Day 3/4, Day 5/13, EOT, TOC
See also
  Status Clinical Trial Phase
Completed NCT00746109 - Study of Wound Packing After Superficial Skin Abscess Drainage Phase 4
Completed NCT00210899 - Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections Phase 3
Completed NCT00761215 - Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections Phase 2
Completed NCT00228982 - Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections Phase 3
Withdrawn NCT00990392 - Topical Antibiotics for Prevention of Intensive Care Unit (ICU) Central Line Infections N/A
Completed NCT00228410 - Study Comparing Tigecycline and Vancomycin With Aztreonam in Complicated Skin and Skin Structure Infections Phase 3
Completed NCT05608382 - Effect of an Antiseptic Solution on the Skin Microbiome N/A
Completed NCT03487549 - Cantharidin and Occlusion in Verruca Epithelium Phase 2
Completed NCT02276482 - Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012) Phase 3
Completed NCT00198679 - Effect of Chlorhexidine Skin Cleansing on Skin Flora Phase 4
Completed NCT03981822 - A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts Phase 2
Completed NCT00711802 - Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections Phase 4
Completed NCT00488761 - Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSI Phase 4
Completed NCT00679302 - Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management Phase 4
Completed NCT00257036 - A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Adults With Mild to Moderate Infections of the Skin and the Supportive Layers Beneath the Skin Phase 2/Phase 3
Completed NCT04485676 - Dalbavancin in Real Clinical Practice in Spain
Completed NCT00785200 - MRSA Colonization and Control in the Dallas County Jail N/A
Completed NCT00257062 - A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Adults With Uncomplicated Infections of the Skin and the Supportive Layers Beneath the Skin Phase 3
Completed NCT02582203 - Clinical and Economic Outcomes of Ceftaroline Fosamil for ABSSSI Documented or at Risk of MRSA Phase 4
Completed NCT00388310 - Effective Antibiotic Treatment of MRSA N/A