Trial · NCT02378480

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

NCT02378480, Phase 3, Completed, Paratek Pharmaceuticals Inc; results first posted 2019-03-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23). Trials, record NCT02378480. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02378480

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)
NCT number: NCT02378480
Status: Completed
Phases: Phase 3
Enrollment: 655 participants, actual
Lead sponsor: Paratek Pharmaceuticals Inc
Conditions: Bacterial Infections, Skin Structures and Soft Tissue Infections
Interventions: Omadacycline, Linezolid
First posted: 2015-03-04
Last updated: 2019-03-21
Results first posted: 2019-03-21

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Early Clinical Response	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 participant was not assessed because they withdrew consent, were lost to follow-up, or other specified reason.
Secondary	Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit	Screening; 7 to 14 days after the last day of therapy	At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the infection was sufficiently resolved such that further antibacterial therapy was not needed. These participants may have had some residual changes related to infection requiring ancillary treatment. Clinical Failure was defined as meeting any of the following criteria: infection required additional treatment with alternative antibacterial therapy; participant received antibacterial therapy between the End-of-Treatment (EOT) Visit and the PTE Visit that may have been effective for the infection under study for a different infection from the one under study; unplanned major surgical intervention for the infection under study between the EOT and PTE Visits; participant died before evaluation. Indeterminate: clinical response to test article could not be adequately inferred.
Secondary	Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population	Screening; 7 to 14 days after the last day of therapy	At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the infection was sufficiently resolved such that further antibacterial therapy was not needed. These participants may have had some residual changes related to infection requiring ancillary treatment. Clinical Failure was defined as meeting any of the following criteria: infection required additional treatment with alternative antibacterial therapy; participant received antibacterial therapy between the EOT Visit and the PTE Visit that may have been effective for the infection under study for a different infection from the one under study; unplanned major surgical intervention for the infection under study between the EOT and PTE Visits; participant died before evaluation.
Secondary	Number of Participants With the Indicated Type of Adverse Event (AE)	0 to 37 days	An AE is defined as any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given a test article or in a clinical study. The event does not need to be causally related to the test article or clinical study. A serious adverse event (SAE) is defined as an event that resulted in death, was life-threatening, required hospitalization or prolongation of an existing hospitalization, resulted in a persistent or significant disability or incapacity, resulted in cancer, or resulted in a congenital anomaly or birth defect. A treatment-emergent AE (TEAE) is defined as any AE that newly appeared, increased in frequency, or worsened in severity on or after the initiation of active test article. Vital sign measurements, electrocardiogram findings, and laboratory values classified as adverse events were included in the analysis. Data are presented as the number of participants with at least 1 of the event.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Early Clinical Response	Screening; 48 to 72 hours after the first dose of test article	Modified Intent-to-Treat (mITT) Population: all randomized participants without a baseline sole Gram-negative ABSSSI pathogen	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit	Screening; 7 to 14 days after the last day of therapy	mITT Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population	Screening; 7 to 14 days after the last day of therapy	CE-PTE Population: all participants in the mITT Population meeting additional pre-defined criteria	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With the Indicated Type of Adverse Event (AE)	0 to 37 days	Safety Population: all randomized participants who received test article	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group38

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Early Clinical Response	Omadacycline	Clinical success	268	Participants
Number of Participants With Early Clinical Response	Linezolid	Clinical success	266	Participants
Number of Participants With Early Clinical Response	Omadacycline	Clinical failure	23	Participants
Number of Participants With Early Clinical Response	Linezolid	Clinical failure	19	Participants
Number of Participants With Early Clinical Response	Omadacycline	Indeterminate	25	Participants
Number of Participants With Early Clinical Response	Linezolid	Indeterminate	26	Participants
Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit	Omadacycline	Clinical success	272	Participants
Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit	Linezolid	Clinical success	260	Participants
Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit	Omadacycline	Clinical failure	20	Participants
Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit	Linezolid	Clinical failure	27	Participants

1 to 10 of 38Source ClinicalTrials.gov

See all 38 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Omadacycline	329
Overall Study	STARTED	Linezolid	326
Overall Study	COMPLETED	Omadacycline	301
Overall Study	COMPLETED	Linezolid	294
Overall Study	NOT COMPLETED	Omadacycline	28
Overall Study	NOT COMPLETED	Linezolid	32

Source ClinicalTrials.gov

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Omadacycline	40	323
other	Nausea	Gastrointestinal disorders	Linezolid	32	322
other	Vomiting	Gastrointestinal disorders	Omadacycline	17	323
other	Vomiting	Gastrointestinal disorders	Linezolid	16	322
other	Diarrhea	Gastrointestinal disorders	Omadacycline	7	323
other	Diarrhea	Gastrointestinal disorders	Linezolid	10	322
other	Infusion site extravasation	General disorders	Omadacycline	28	323
other	Infusion site extravasation	General disorders	Linezolid	19	322
other	Subcutaneous abscess	Infections and infestations	Omadacycline	16	323
other	Subcutaneous abscess	Infections and infestations	Linezolid	19	322

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Omadacycline	1	323
Total, all-cause mortality	Linezolid	2	322
Total, other adverse events	Omadacycline	104	323
Total, other adverse events	Linezolid	101	322
Total, serious adverse events	Omadacycline	12	323
Total, serious adverse events	Linezolid	8	322

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30726689	DERIVED	PubMed
31367742	DERIVED	PubMed
33326848	DERIVED	PubMed
33458763	DERIVED	PubMed
35776862	DERIVED	PubMed
39461915	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Omadacycline vs Linezolid: deaths from any cause	Trial comparisons
Omadacycline vs Linezolid: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02378480

GET https://conductscience.org/api/trials/v1/NCT02378480/results?page=2

API reference For AI assistants