Omadacycline

DRUG10 trials

Sponsors

Paratek Pharmaceuticals Inc, Hartford Hospital, Methodist Health System, University of Houston, Zai Lab (Hong Kong), Ltd.

Conditions

Acute PyelonephritisBacterial InfectionsBacterial PneumoniaCommunity-Acquired InfectionsCommunity-acquired Bacterial PneumoniaCommunity-acquired PneumoniaDiabetesDiabetic Foot Infection

Phase 1

Omadacycline Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis

CompletedNCT04144374

Hartford HospitalDiabetes, Healthy Volunteers, Wound Infection

Start: 2020-02-10End: 2021-07-29Updated: 2021-08-25

Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia

CompletedNCT04160260

Paratek Pharmaceuticals IncCommunity-acquired Pneumonia

Start: 2019-11-28End: 2020-04-13Updated: 2021-11-03

Microbiome Effect of Omadacycline on Healthy Volunteers

CompletedNCT06030219

University of HoustonHealthy Volunteers

Start: 2020-10-12End: 2023-09-01Updated: 2025-03-25

Phase 2

IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis

CompletedNCT03757234

Paratek Pharmaceuticals IncAcute Pyelonephritis

Start: 2018-11-19End: 2019-07-24Updated: 2020-07-07

Phase 3

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

CompletedNCT02378480

Paratek Pharmaceuticals IncBacterial Infections, Skin Structures and Soft Tissue Infections

Start: 2015-06-30End: 2016-05-31Updated: 2019-03-21

Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)

CompletedNCT02531438

Paratek Pharmaceuticals IncBacterial Pneumonia, Community-Acquired Infections

Start: 2015-11-30End: 2017-03-10Updated: 2019-01-16

Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI

CompletedNCT02877927

Paratek Pharmaceuticals IncBacterial Infections, Skin Structures and Soft Tissue Infections

Start: 2016-08-31End: 2017-06-06Updated: 2018-11-30

Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia

CompletedNCT04779242

Paratek Pharmaceuticals IncBacterial Pneumonia, Community-acquired Pneumonia

Start: 2021-02-25End: 2024-03-27Updated: 2025-04-09

A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP

RecruitingNCT06162286

Zai Lab (Hong Kong), Ltd.Community-acquired Bacterial Pneumonia

Start: 2023-11-17End: 2025-11-30Target: 100Updated: 2024-06-14

Unknown Phase

Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis

CompletedNCT04714411

Methodist Health SystemDiabetic Foot Infection

Start: 2020-11-05End: 2025-07-14Updated: 2026-03-27

Related Papers

P-618. Pooled Microbiological Outcomes from the Phase 3, Randomized OPTIC and OPTIC-2 Trials of Omadacycline vs Moxifloxacin in Community-acquired Bacterial Pneumonia

Open Forum Infectious Diseases2026-01-01

A Randomized Phase 1 Study Investigating Gut Microbiome Changes With Moxifloxacin vs Oral Vancomycin: Implications for Clostridioides difficile Risk.

2025-12-01

Omadacycline versus moxifloxacin for community-acquired bacterial pneumonia (OPTIC-2): a phase 3b, randomised, double-blind, multicentre, controlled, noninferiority trial.

2025-11-20

Phase I trial comparing bile acid and short-chain fatty acid alterations in stool collected from human subjects treated with omadacycline or vancomycin

Antimicrobial Agents and Chemotherapy2025-01-172 citations

Intravenous Versus Oral Omadacycline or Linezolid for Acute Bacterial Skin and Skin Infections: A post hoc Analysis of the OASIS Trials.

2024-10-26

Fecal Pharmacokinetics and Gut Microbiome Effects of Oral Omadacycline Versus Vancomycin in Healthy Volunteers

The Journal of Infectious Diseases2023-12-0511 citations

2903. Early Experience With Omadacycline For The Treatment Of Diabetic Foot Infections

Open Forum Infectious Diseases2023-11-271 citations

Omadacycline in the treatment of community-acquired bacterial pneumonia in patients with comorbidities: a post-hoc analysis of the phase 3 OPTIC trial

Frontiers in Medicine2023-07-287 citations

Omadacycline in Skin Infections and Pneumonia: A Review of the Evidence.

2022-06-011 citations

Omadacycline vs moxifloxacin in adults with community-acquired bacterial pneumonia.

2021-01-2013 citations

Safety and efficacy of omadacycline by BMI categories and diabetes history in two Phase III randomized studies of patients with acute bacterial skin and skin structure infections

Journal of Antimicrobial Chemotherapy2020-12-2114 citations

Safety and efficacy of omadacycline for treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections in patients with mild-to-moderate renal impairment

International Journal of Antimicrobial Agents2020-12-159 citations

1687. Omadacycline in Female Adults With Acute Pyelonephritis: Results from a Randomized, Double-Blind, Adaptive Phase 2 Study

Open Forum Infectious Diseases2020-10-014 citations

The efficacy and safety of omadacycline in treatment of acute bacterial infection: A systemic review and meta-analysis of randomized controlled trials.

2019-12-017 citations

665. In vitro Activity of Omadacycline Against Recent (2018) Bacterial Pathogens from the United States and Europe Obtained from Skin and Skin Structure, Respiratory, and Urinary Tract Infections

Open Forum Infectious Diseases2019-10-01

Once-daily oral omadacycline versus twice-daily oral linezolid for acute bacterial skin and skin structure infections (OASIS-2): a phase 3, double-blind, multicentre, randomised, controlled, non-inferiority trial.

2019-08-2969 citations

Omadacycline for Acute Bacterial Skin and Skin Structure Infections

Clinical Infectious Diseases2019-05-1345 citations

Early Clinical Response in Community-acquired Bacterial Pneumonia: From Clinical Endpoint to Clinical Practice

Clinical Infectious Diseases2019-05-1317 citations

Omadacycline for Community-Acquired Bacterial Pneumonia

New England Journal of Medicine2019-02-06215 citations

Omadacycline for Acute Bacterial Skin and Skin-Structure Infections

New England Journal of Medicine2019-02-06148 citations