Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous (IV) Oritavancin
Acute Bacterial Skin and Skin Structure InfectionThis protocol describes a randomized, open-label study to evaluate the safety and tolerability of single-dose intravenous (IV) oritavancin diphosphate (oritavancin) versus standard of care (SoC) antibiotics for the treatment of pediatric subjects with acute bacterial skin and skin structure infections (ABSSSIs). This study involves two oritavancin products, ORBACTIV® and KIMYRSATM. Oritavancin is the active drug substance in both ORBACTIV and KIMYRSA. This study protocol distinguishes the differences between ORBACTIV and KIMYRSA by providing product-specific data, and information and guidance for Investigators. "Oritavancin" is used to describe drug product data, and information and guidance that is not specific to ORBACTIV or KIMYRSA (i.e., applies to both). The study involves pharmacokinetic (PK) sampling and will evaluate clinical outcome assessments. The study was designed to capture adequate data while minimizing the impact to subjects and their caregivers.
Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children,...
Methicillin-Resistant Staphylococcus AureusBacterial Infections1 moreTo determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by susceptible Gram-positive organisms, including methicillin-resistant strains of Staphylococcus aureus.
Fosfomycin i.v. for Treatment of Severely Infected Patients
Bacterial InfectionsBone Diseases19 moreThe purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin, including patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue infection, endocarditis or other infections, each as far as covered by the respective nationally relevant SmPC.
Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute Skin...
Skin DiseasesBacterial1 moreIn this pilot study, the objective is to determine the prevalence of asymptomatic carriage of S. aureus in patients with ABSSSIs and minor cutaneous abscesses after therapy with either linezolid or clindamycin at 40 days after the completion of therapy. Secondarily, the investigators will assess the efficacy of linezolid vs. clindamycin in the empiric therapy of ABSSSIs and minor cutaneous abscesses, as well as the genotypic spectrum of S. aureus isolates causing ABSSSIs or minor cutaneous abscesses and colonization in the target patient population before and after therapy. Given the results of a recent study on linezolid and vancomycin and the investigator's own experience, it is hypothesized that persistent MRSA carriage will be less common after therapy with linezolid for ABSSSIs and minor cutaneous abscesses than it is with oral clindamycin.
Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI)...
Complicated Skin and Skin Structure InfectionsS. Aureus Bacteremia1 moreThis is a multicenter, randomized, evaluator-blinded, comparator-controlled study. Participants were to be randomized (1:1) to daptomycin or comparator, stratified by degree of renal impairment (creatinine clearance [CLcr] 30 - 50 milliliters per minute [mL/min] [moderate impairment] and <30 mL/min [severe impairment]) and by type of infection (bacteremia and complicated skin and skin structure infections [cSSSI]) to create 4 cohorts defined as follows: Cohort 1: Bacteremia and CLcr <30 mL/min Cohort 2: Bacteremia and CLcr 30 - 50 mL/min Cohort 3: cSSSI and CLcr <30 mL/min Cohort 4: cSSSI and CLcr 30 - 50 mL/min Participants will be treated and evaluated for safety and microbiological and clinical efficacy in accordance with their type of infection and degree of renal impairment. Peak and trough samples will be collected to assess exposure to daptomycin for participants on Day 1 and following the 5th dose.
Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure...
Soft Tissue InfectionsThis is a Phase 4, randomized, open-label, multicenter, comparative study designed to further evaluate the pharmacokinetics of intravenous (i.v.) daptomycin and the safety and efficacy of daptomycin relative to comparator in the treatment of complicated skin and skin structure infections in patients with renal impairment.
Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections...
Staphylococcal Skin InfectionsThis study will evaluate the safety and efficacy of daptomycin against complicated skin and skin-structure infections in adults
Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection...
Skin DiseasesInfectiousA Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).
Evaluation of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections...
Acute Bacterial Skin and Skin Structure InfectionsThis study will evaluate a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) for the treatment of ABSSSI compared to usual care.
Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial...
Acute Bacterial Skin and Skin Structure InfectionsThis is a phase III, multi-center, randomized, active-comparator, study in subjects with ABSSSI. The study has two subgroups for assessment of efficacy and safety - oral subgroup 1 and IV subgroup 2. Each subgroup will comprise of two treatment arms.