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Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)

A Phase 3 Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Linezolid IV/PO for Treating Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

NCT02378480•Paratek Pharmaceuticals Inc

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to linezolid in the treatment of adults with acute bacterial skin and skin structure infections.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients, ages 18 years or older who have signed the informed consent
•Has a qualifying skin and skin structure infection
•Female patients must not be pregnant at the time of enrollment
•Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

Exclusion Criteria

•Infections where the outcome is strongly influenced by factors other than protocol-defined treatment and procedures, that require antibacterial treatment for greater than 14 days
•Evidence of significant immunological disease
•Severe sepsis or septic shock
•Has a history of hypersensitivity or allergic reaction to any tetracycline or to linezolid
•Has received an investigational drug within past 30 days
•Women who are pregnant or nursing

Locations (78)

Site 261

Mobile, Alabama, United States

Site 262

Chula Vista, California, United States

Site 254

La Mesa, California, United States

Site 258

Oceanside, California, United States

Site 252

Santa Ana, California, United States

Site 260

Santa Ana, California, United States

Site 269

Stockton, California, United States

Site 259

Miami, Florida, United States

Site 264

West Palm Beach, Florida, United States

Site 256

Augusta, Georgia, United States

Key Dates

Start Date

June 1, 2015

Primary Completion Date

April 1, 2016

Completion Date

May 1, 2016

Last Updated

March 21, 2019

Enrollment

655

ACTUAL participants

Conditions

Bacterial InfectionsSkin Structures and Soft Tissue Infections

Interventions

Omadacycline

DRUG

Linezolid

DRUG

[18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects

NCT04263792

Bacterial Infections

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RECRUITINGPHASE2

Clinical Trial to Study the Efficacy and Safety of Fluorothiazinone (N.F. Gamaleya NRCEM) in Prophylaxis of Nosocomial Bacterial Infections With Participation of Patients on MV

NCT06135350

Gram Negative PneumoniaGram-Negative Bacterial Infections+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 21, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)

Inclusion Criteria

Exclusion Criteria

[18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects

Clinical Trial to Study the Efficacy and Safety of Fluorothiazinone (N.F. Gamaleya NRCEM) in Prophylaxis of Nosocomial Bacterial Infections With Participation of Patients on MV

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