Trial · NCT02877927

Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI

NCT02877927, Phase 3, Completed, Paratek Pharmaceuticals Inc; results first posted 2018-11-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI. Trials, record NCT02877927. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02877927

On this page

Trial

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

Title: Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI
NCT number: NCT02877927
Status: Completed
Phases: Phase 3
Enrollment: 735 participants, actual
Lead sponsor: Paratek Pharmaceuticals Inc
Conditions: Bacterial Infections, Skin Structures and Soft Tissue Infections
Interventions: Omadacycline, Linezolid
First posted: 2016-08-24
Last updated: 2018-11-30
Results first posted: 2018-11-30

Source ClinicalTrials.gov

Registered outcomes3

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; infection was sufficiently resolved such that further antibacterial therapy was not needed. 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; other specified reason. Indeterminate The 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; infection was sufficiently resolved such that further antibacterial therapy was not needed. 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; other specified reason.

Source ClinicalTrials.gov

Outcomes3

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

Source ClinicalTrials.gov

Results by group16

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	315	Participants
Number of Participants With Early Clinical Response	Linezolid	Clinical success	297	Participants
Number of Participants With Early Clinical Response	Omadacycline	Clinical failure	26	Participants
Number of Participants With Early Clinical Response	Linezolid	Clinical failure	32	Participants
Number of Participants With Early Clinical Response	Omadacycline	Indeterminate	19	Participants
Number of Participants With Early Clinical Response	Linezolid	Indeterminate	31	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	303	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	291	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	12	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	21	Participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Omadacycline	368
Overall Study	STARTED	Linezolid	367
Overall Study	COMPLETED	Omadacycline	314
Overall Study	COMPLETED	Linezolid	310
Overall Study	NOT COMPLETED	Omadacycline	54
Overall Study	NOT COMPLETED	Linezolid	57

Source ClinicalTrials.gov

Adverse events44

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	111	368
other	Nausea	Gastrointestinal disorders	Linezolid	28	367
other	Vomiting	Gastrointestinal disorders	Omadacycline	62	368
other	Vomiting	Gastrointestinal disorders	Linezolid	11	367
other	Diarrhea	Gastrointestinal disorders	Omadacycline	15	368
other	Diarrhea	Gastrointestinal disorders	Linezolid	10	367
other	Abdominal pain upper	Gastrointestinal disorders	Omadacycline	10	368
other	Abdominal pain upper	Gastrointestinal disorders	Linezolid	4	367
other	Wound infection	Infections and infestations	Omadacycline	21	368
other	Wound infection	Infections and infestations	Linezolid	16	367

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Omadacycline	0	368
Total, all-cause mortality	Linezolid	1	367
Total, other adverse events	Omadacycline	166	368
Total, other adverse events	Linezolid	83	367
Total, serious adverse events	Omadacycline	5	368
Total, serious adverse events	Linezolid	5	367

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31367742	DERIVED	PubMed
31474458	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/NCT02877927

GET https://conductscience.org/api/trials/v1/NCT02877927/events?page=2

API reference For AI assistants