NCT02531438 is a Phase 3 clinical trial of Omadacycline in Bacterial Pneumonia, sponsored by Paratek Pharmaceuticals Inc.

Who is sponsoring NCT02531438?

NCT02531438 is sponsored by Paratek Pharmaceuticals Inc.

What drugs are being tested in NCT02531438?

Interventions in NCT02531438: Omadacycline, Moxifloxacin.

What condition does NCT02531438 study?

NCT02531438 studies Bacterial Pneumonia, Community-Acquired Infections.

Is NCT02531438 still recruiting?

NCT02531438 is currently completed. Last updated 3 January 2019.

Are results published for NCT02531438?

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

Last reviewed 2019-01-03 · How we verify

NCT02531438

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 Intravenous (IV)/Oral (PO) to Moxifloxacin IV/PO for Treating Adults Subjects With Community-Acquired Bacterial Pneumonia

Completed Phase 3 Results posted Last updated 3 January 2019

What this trial tests

Phase 3 trial testing Omadacycline in Bacterial Pneumonia in 774 participants. Completed in 10 March 2017.

Timeline

1 November 2015

Primary endpoint
5 February 2017

10 March 2017

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	774
Start date	1 November 2015
Primary completion	5 February 2017
Estimated completion	10 March 2017
Sites	140 locations across United States, Belgium, Brazil, Bulgaria, Croatia, Czechia, Georgia, Germany

Drugs / interventions tested

Omadacycline (OMADACYCLINE) — full drug profile →
Moxifloxacin (moxifloxacin) — full drug profile →

Conditions studied

Bacterial Pneumonia — all drugs for Bacterial Pneumonia →
Community-Acquired Infections — all drugs for Community-Acquired Infections →

Sponsor

Paratek Pharmaceuticals Inc — full company profile →

Who can join

18 and older, any sex, with Bacterial Pneumonia or Community-Acquired 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; 72 to 120 hours after the first dose of test article
Early clinical response is defined as clinical success, categorized by survival with improvement of at least 1 level compared to Baseline in at least 2 CABP symptoms (cough, sputum production, pleuritic chest pain, and dyspnea) with no worsening in the other CABP symptoms. Response was determined programmatically using the investigator's assessment of the CABP symptoms. The severity of the partici

Sponsor's own description

The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.

Publications & conference data

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

Omadacycline for Community-Acquired Bacterial Pneumonia.
Stets R, Popescu M, Gonong JR, Mitha I, et al · · 2019 · cited 170× · PMID 30726692 · DOI 10.1056/nejmoa1800201
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
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
An Integrated Safety Summary of Omadacycline, a Novel Aminomethylcycline Antibiotic.
Opal S, File TM, van der Poll T, Tzanis E, et al · · 2019 · cited 27× · PMID 31367740 · DOI 10.1093/cid/ciz398

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 Pneumonia

Currently open trials in the same condition.

NCT06966284 — A Post-Marketing Study to Assess the Efficacy and Safety of Intravenous Polymyxin B and Colistin Methanesulfonate in Pat · recruiting
NCT06804096 — Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP) · Phase 4 · 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 NCT02531438 (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: 3 January 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/NCT02531438.

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