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Skin Diseases, Bacterial clinical trials

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NCT ID: NCT05599295 Recruiting - Clinical trials for Acute Bacterial Skin and Skin Structure Infection

Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous (IV) Oritavancin

Start date: June 15, 2023
Phase: Phase 2
Study type: Interventional

This 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.

NCT ID: NCT04485676 Completed - Clinical trials for Skin Diseases, Infectious

Dalbavancin in Real Clinical Practice in Spain

REAL-DAL
Start date: July 15, 2020
Phase:
Study type: Observational

The aim of this study is to describe the real clinical use of Dalbavancin in Spain between January 2018 and December 2019.

NCT ID: NCT04298463 Completed - Clinical trials for Acute Bacterial Skin and Skin Structure Infection

Retrospective Effectiveness Study of Dalbavancin and Other Standard of Care of the Same Class in Patients With ABSSSI

REDS
Start date: June 18, 2020
Phase:
Study type: Observational

The aim of this study is to collect the data on the effectiveness of dalbavancin in terms of save of hospitalization days on patients treated between June 2017 and June 2019 in two countries (Italy and Greece) vs the other Standards of care of the same class (SoC; i.v. lipo and glycopeptides) in a real-life context. Time to discharge from the start of therapy for ABSSSI in the hospital context will be assessed and all relevant data available on patient management, clinical, microbiological and safety outcomes during hospitalization and in the follow-up visits up to 30 days from discharge will be collected and evaluated.

NCT ID: NCT03873987 Completed - Clinical trials for Acute Bacterial Skin and Skin Structure Infection

Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients

Start date: July 16, 2019
Phase: Phase 1
Study type: Interventional

This study is being conducted to evaluate the pharmacokinetic (PK) and safety of Kimyrsa versus the approved oritavancin formulation in subjects with acute bacterial skin and skin structure infection (ABSSSI). Kimyrsa adjusts the infusion time, concentration and reconstitution/administration solutions of a single 1200 mg intravenous (IV) infusion of oritavancin

NCT ID: NCT03747497 Completed - Clinical trials for Gram-Positive Bacterial Infections

Contezolid Acefosamil Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection

Start date: November 15, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether contezolid acefosamil is as safe and effective as linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections

NCT ID: NCT03716024 Completed - Clinical trials for Infectious Skin Disease

Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)

Start date: July 18, 2007
Phase: Phase 2
Study type: Interventional

A Phase II trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).

NCT ID: NCT03405064 Completed - Clinical trials for Acute Bacterial Skin and Skin Structure Infections

Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Start date: August 25, 2017
Phase: Phase 3
Study type: Interventional

This 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.

NCT ID: NCT03233438 Completed - Clinical trials for Bacterial Infections

Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Start date: July 24, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the effect of a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) compared to usual care for the treatment of ABSSI (Acute Bacterial Skin and Skin Structure Infections)

NCT ID: NCT03176134 Completed - Clinical trials for Acute Bacterial Skin and Skin Structure Infections

A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018)

Start date: January 20, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety, tolerability, and efficacy of tedizolid phosphate (MK-1986) compared with comparator antibacterial agent in participants from birth to less than 12 years of age with acute bacterial skin and skin structure infections (ABSSSI).

NCT ID: NCT03137173 Completed - Clinical trials for Acute Bacterial Skin and Skin Structure Infections

Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections

Start date: February 19, 2018
Phase: Phase 3
Study type: Interventional

This was a randomized, double-blind, active-controlled, parallel-group, multicenter study in adult hospitalized patients to establish the safety and efficacy of ceftobiprole medocaril compared with vancomycin plus aztreonam in the treatment of acute bacterial skin and skin structure infections (ABSSSIs).