NCT02378480 is a Phase 3 clinical trial of Omadacycline in Bacterial Infections, sponsored by Paratek Pharmaceuticals Inc.

Who is sponsoring NCT02378480?

NCT02378480 is sponsored by Paratek Pharmaceuticals Inc.

What drugs are being tested in NCT02378480?

Interventions in NCT02378480: Omadacycline, Linezolid.

What condition does NCT02378480 study?

NCT02378480 studies Bacterial Infections, Skin Structures and Soft Tissue Infections.

Is NCT02378480 still recruiting?

NCT02378480 is currently completed. Last updated 20 March 2019.

Are results published for NCT02378480?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-03-20 · How we verify

NCT02378480

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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)

Completed Phase 3 Results posted Last updated 20 March 2019

What this trial tests

Phase 3 trial testing Omadacycline in Bacterial Infections in 655 participants. Completed in 1 May 2016.

Timeline

1 June 2015

Primary endpoint
1 April 2016

1 May 2016

Quick facts

Lead sponsor	Paratek Pharmaceuticals Inc
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	655
Start date	1 June 2015
Primary completion	1 April 2016
Estimated completion	1 May 2016
Sites	78 locations across United States, Bulgaria, Croatia, Greece, Hungary, Israel, Latvia, Peru

Drugs / interventions tested

Omadacycline (OMADACYCLINE) — full drug profile →
Linezolid — full drug profile →

Conditions studied

Bacterial Infections — all drugs for Bacterial Infections →
Skin Structures and Soft Tissue Infections — all drugs for Skin Structures and Soft Tissue Infections →

Sponsor

Paratek Pharmaceuticals Inc — full company profile →

Who can join

18 and older, any sex, with Bacterial Infections or Skin Structures and Soft Tissue Infections. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of Participants With Early Clinical Response
Time frame: Screening; 48 to 72 hours after the first dose of test article
Early clinical response is defined as clinical success, which is categorized as survival with at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to Screening measurements, without receiving any rescue antibacterial therapy. An indeterminate classification is used for a response that could not be adequately inferred because the partic

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Omadacycline for Acute Bacterial Skin and Skin-Structure Infections.
O'Riordan W, Green S, Overcash JS, Puljiz I, et al · · 2019 · cited 113× · PMID 30726689 · DOI 10.1056/nejmoa1800170
Comparison of Omadacycline and Tigecycline Pharmacokinetics in the Plasma, Epithelial Lining Fluid, and Alveolar Cells of Healthy Adult Subjects.
Gotfried MH, Horn K, Garrity-Ryan L, Villano S, et al · · 2017 · cited 107× · PMID 28696233 · DOI 10.1128/aac.01135-17
Pharmacokinetics and Pharmacodynamics of Oral and Intravenous Omadacycline.
Rodvold KA, Pai MP. · · 2019 · cited 40× · PMID 31367744 · DOI 10.1093/cid/ciz309
Pharmacokinetics and Safety of Omadacycline in Subjects with Impaired Renal Function.
Berg JK, Tzanis E, Garrity-Ryan L, Bai S, et al · · 2018 · cited 39× · PMID 29158281 · DOI 10.1128/aac.02057-17
Safety and Pharmacokinetics of the Aminomethylcycline Antibiotic Omadacycline Administered to Healthy Subjects in Oral Multiple-Dose Regimens.
Bundrant LA, Tzanis E, Garrity-Ryan L, Bai S, et al · · 2018 · cited 32× · PMID 29180524 · DOI 10.1128/aac.01487-17
Novel Antibiotics for Multidrug-Resistant Gram-Positive Microorganisms.
Koulenti D, Xu E, Mok IYS, Song A, et al · · 2019 · cited 31× · PMID 31426596 · DOI 10.3390/microorganisms7080270
Omadacycline for Acute Bacterial Skin and Skin Structure Infections.
Abrahamian FM, Sakoulas G, Tzanis E, Manley A, et al · · 2019 · cited 30× · PMID 31367742 · DOI 10.1093/cid/ciz396
Pharmacokinetics, Safety, and Clinical Outcomes of Omadacycline in Women with Cystitis: Results from a Phase 1b Study.
Overcash JS, Bhiwandi P, Garrity-Ryan L, Steenbergen J, et al · · 2019 · cited 28× · PMID 30858208 · DOI 10.1128/aac.02083-18

Verify or expand the search:

Other trials of Omadacycline

Trials testing the same drug.

NCT06162286 — A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxac · Phase 3 · recruiting
NCT04779242 — Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia · Phase 3 · completed
NCT04714411 — Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomye · completed
NCT06030219 — Microbiome Effect of Omadacycline on Healthy Volunteers · Phase 1 · completed
NCT04144374 — Omadacycline Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialy · Phase 1 · completed

Other recruiting trials for Bacterial Infections

Currently open trials in the same condition.

NCT07017777 — A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infant · Phase 3 · recruiting
NCT07104162 — A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal I · Phase 1 · recruiting
NCT07207291 — Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers · Phase 1 · recruiting
NCT07056881 — Monotherapy vs Combination Therapy for Bone Infections Caused by Pseudomonas Aeruginosa · recruiting
NCT06592586 — A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women · Phase 2, PHASE3 · active not recruiting

Other Paratek Pharmaceuticals Inc trials

Trials by the same sponsor.

NCT05217537 — Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Inf · Phase 1 · completed
NCT04922554 — Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc) · Phase 2 · completed
NCT04779242 — Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia · Phase 3 · completed
NCT04160260 — Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia · Phase 1 · completed
NCT03757234 — IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02378480 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Paratek Pharmaceuticals Inc
Last refreshed: 20 March 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02378480.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing