Bacterial InfectionsPhase 3NCT02378480

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

A Phase 3 study testing Omadacycline and Linezolid in people with Bacterial Infections and Skin Structures and Soft Tissue Infections, run by Paratek Pharmaceuticals Inc at 78 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bacterial Infections, Skin Structures and Soft Tissue Infections
What is being tested?: Omadacycline and Linezolid
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 655 participants
Where: 78 sitesin 14 countries
Study dates: Jun 2015to May 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients, ages 18 years or older who have signed the informed consent
Has a qualifying skin and skin structure infection
Female patients must not be pregnant at the time of enrollment
Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

Who cannot join

Infections where the outcome is strongly influenced by factors other than protocol-defined treatment and procedures, that require antibacterial treatment for greater than 14 days
Evidence of significant immunological disease
Severe sepsis or septic shock
Has a history of hypersensitivity or allergic reaction to any tetracycline or to linezolid
Has received an investigational drug within past 30 days
Women who are pregnant or nursing

Trial locations and contacts

78 sites in 14 countries.

Country

City, postcode or hospital

78 sites in 14 countries

United States18 sites

Site 256
Augusta, Georgia, 30909
Site 273
Buffalo, New York, 14215
Site 266
Butte, Montana, 59701
Site 262
Chula Vista, California, 91911
Site 253
Columbus, Georgia, 31904
Site 268
Detroit, Michigan, 48202
Site 254
La Mesa, California, 91942
Site 263
Las Vegas, Nevada, 89119
Site 259
Miami, Florida, 33144
Site 261
Mobile, Alabama, 36608
Site 258
Oceanside, California, 92056
Site 255
Rapid City, South Dakota, 57702
Site 252
Santa Ana, California, 92705
Site 260
Santa Ana, California, 92705
Site 270
Somers Point, New Jersey, 08244
Site 257
Springfield, Massachusetts, 01199
Site 269
Stockton, California, 95204
Site 264
West Palm Beach, Florida, 33407

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Ukraine9 sites

Site 172
Dnipropetrovsk
Site 173
Dnipropetrovsk
Site 179
Kharkiv
Site 171
Kyiv
Site 170
Lviv
Site 174
Odesa
Site 175
Uzhhorod
Site 178
Vinnytsia
Site 176
Zaporizhia

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Romania7 sites

Site 141
Bucharest
Site 142
Bucharest
Site 146
Bucharest
Site 144
Cluj-Napoca
Site 140
Craiova
Site 143
Târgu Mureş
Site 145
Timișoara

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Peru6 sites

Site 234
Cusco
Site 233
Lima
Site 236
Lima
Site 238
Lima
Site 239
Lima
Site 237
Trujillo

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Bulgaria5 sites

Site 104
Pleven
Site 102
Plovdiv
Site 105
Plovdiv
Site 103
Rousse
Site 101
Sofia

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Croatia5 sites

Site 205
Slavonski Brod
Site 201
Zagreb, 10000
Site 203
Zagreb, 10000
Site 202
Zagreb
Site 204
Zagreb

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Latvia5 sites

Site 122
Daugavpils
Site 123
Liepāja
Site 124
Rēzekne
Site 120
Riga
Site 121
Riga

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Poland5 sites

Site 130
Bydgoszcz
Site 133
Katowice
Site 131
Lodz
Site 134
Olsztyn
Site 132
Warsaw

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Greece4 sites

Site 207
Athens
Site 211
Athens
Site 208
Thessaloniki
Site 209
Thessaloniki

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Hungary4 sites

Site 110
Budapest
Site 111
Budapest
Site 114
Miskolc
Site 113
Szeged

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Israel4 sites

Site 213
Holon
Site 219
Kfar Saba
Site 214
Nazareth
Site 216
Safed

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South Africa2 sites

Site 241
Benoni, Gauteng
Site 244
Thabazimbi, Limpopo

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Spain2 sites

Site 221
Barcelona, Catalonia
Site 222
Terrassa, Barcelona

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Turkey (Türkiye)2 sites

Site 247
Ankara
Site 246
Trabzon

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About this study

Official title: 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)

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.

Conditions: Bacterial Infections, Skin Structures and Soft Tissue Infections
Being tested: Omadacycline, Linezolid
Medical subject headings: Bacterial Infections, Soft Tissue Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OmadacyclineDrug
Injection for IV dosing; Tablets for oral dosing
LinezolidDrug
Also called Zyvox
Infusion solution for IV dosing; Tablets for oral dosing

Study groups in NCT02378480
Study group	Role	What they receive
Omadacycline	Experimental	Omadacycline IV; Omadacycline tablets Receives: Drug: Omadacycline
Linezolid	Active comparator	Linezolid IV; Linezolid tablets Receives: Drug: Linezolid

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Early Clinical Response
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.
Measured: Screening; 48 to 72 hours after the first dose of test article

Secondary outcomes (3)

Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit
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.
Measured: Screening; 7 to 14 days after the last day of therapy
Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population
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.
Measured: Screening; 7 to 14 days after the last day of therapy
Number of Participants With the Indicated Type of Adverse Event (AE)
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.
Measured: 0 to 37 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015May 2016

First posted4 Mar 2015 (estimated)
Study startJun 2015
Primary completionApr 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 655 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02378480
Sponsor's protocol ID: PTK0796-ABSI-1108
Status last verified: Mar 2019
First submitted: 19 Feb 2015
Last updated: 21 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Rodriguez GD, Warren N, Yashayev R, Chitra S, Amodio-Groton M, Wright K. Intravenous Versus Oral Omadacycline or Linezolid for Acute Bacterial Skin and Skin Infections: A post hoc Analysis of the OASIS Trials. Infect Dis Ther. 2024 Dec;13(12):2637-2648. doi: 10.1007/s40121-024-01057-3. Epub 2024 Oct 26.
PubMed 39461915
Vacalis S, Brunton S, Gindi J. Omadacycline in Skin Infections and Pneumonia: A Review of the Evidence. J Fam Pract. 2022 Jun;71(5 Suppl):S10-S21. doi: 10.12788/jfp.0424.
PubMed 35776862
Pai MP, Wilcox MH, Chitra S, McGovern PC. 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. J Antimicrob Chemother. 2021 Apr 13;76(5):1315-1322. doi: 10.1093/jac/dkaa558.
PubMed 33458763
Cornely OA, File TM Jr, Garrity-Ryan L, Chitra S, Noble R, McGovern PC. 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. Int J Antimicrob Agents. 2021 Feb;57(2):106263. doi: 10.1016/j.ijantimicag.2020.106263. Epub 2020 Dec 14.
PubMed 33326848
Abrahamian FM, Sakoulas G, Tzanis E, Manley A, Steenbergen J, Das AF, Eckburg PB, McGovern PC. Omadacycline for Acute Bacterial Skin and Skin Structure Infections. Clin Infect Dis. 2019 Aug 1;69(Suppl 1):S23-S32. doi: 10.1093/cid/ciz396.
PubMed 31367742
O'Riordan W, Green S, Overcash JS, Puljiz I, Metallidis S, Gardovskis J, Garrity-Ryan L, Das AF, Tzanis E, Eckburg PB, Manley A, Villano SA, Steenbergen JN, Loh E. Omadacycline for Acute Bacterial Skin and Skin-Structure Infections. N Engl J Med. 2019 Feb 7;380(6):528-538. doi: 10.1056/NEJMoa1800170.
PubMed 30726689

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT02378480
Acronym / sponsor ID: PTK0796-ABSI-1108
Conditions: Bacterial Infections, Skin Structures and Soft Tissue Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 655 participants (actual)
Lead sponsor: Paratek Pharmaceuticals IncIndustry (pharma, biotech, devices)
Study start: Jun 2015
Primary completion: Apr 2016 (actual)
Study completion: May 2016 (actual)
First posted: 4 Mar 2015 (estimated)
Results: Posted 21 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Omadacycline	Experimental	Drug: OmadacyclineOmadacycline IV; Omadacycline tablets
Linezolid	Active comparator	Drug: LinezolidLinezolid IV; Linezolid tablets

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients, ages 18 years or older who have signed the informed consent
Has a qualifying skin and skin structure infection
Female patients must not be pregnant at the time of enrollment
Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

Key exclusion criteria (6 listed)

Infections where the outcome is strongly influenced by factors other than protocol-defined treatment and procedures, that require antibacterial treatment for greater than 14 days
Evidence of significant immunological disease
Severe sepsis or septic shock
Has a history of hypersensitivity or allergic reaction to any tetracycline or to linezolid
Has received an investigational drug within past 30 days

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OmadacyclineInjection for IV dosing; Tablets for oral dosing	Drug	Omadacycline
LinezolidAlso: ZyvoxInfusion solution for IV dosing; Tablets for oral dosing	Drug	Linezolid

Primary outcome

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 participant was not assessed because they withdrew consent, were lost to follow-up, or other specified reason.

3 secondary outcomes

Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit
Time frame: Screening; 7 to 14 days after the last day of therapy
Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population
Time frame: Screening; 7 to 14 days after the last day of therapy
Number of Participants With the Indicated Type of Adverse Event (AE)
Time frame: 0 to 37 days

Results and safety

Results posted to the registry on 21 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Omadacycline	329	301
Linezolid	326	294

Primary outcome: Number of Participants With Early Clinical Response

Time frame: Screening; 48 to 72 hours after the first dose of test article. Count of participants. Unit: Participants

Measure	Omadacycline n = 316	Linezolid n = 311
Clinical success	268	266
Clinical failure	23	19
Indeterminate	25	26

Omadacycline vs Linezolid: treatment difference: -0.7 (95% CI -6.3 to 4.9)

Population analysed: Modified Intent-to-Treat (mITT) Population: all randomized participants without a baseline sole Gram-negative ABSSSI pathogen

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed from the signing of Informed Consent Form to the time of the Final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omadacycline	12 of 323 (3.7%)	104 of 323 (32.2%)	1 of 323
Linezolid	8 of 322 (2.5%)	101 of 322 (31.4%)	2 of 322

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39461915Rodriguez GD, Warren N, Yashayev R, Chitra S, Amodio-Groton M, Wright K. Intravenous Versus Oral Omadacycline or Linezolid for Acute Bacterial Skin and Skin Infections: A post hoc Analysis of the OASIS Trials. Infect Dis Ther. 2024 Dec;13(12):2637-2648. doi: 10.1007/s40121-024-01057-3. Epub 2024 Oct 26.
Derived from this study: PubMed 35776862Vacalis S, Brunton S, Gindi J. Omadacycline in Skin Infections and Pneumonia: A Review of the Evidence. J Fam Pract. 2022 Jun;71(5 Suppl):S10-S21. doi: 10.12788/jfp.0424.
Derived from this study: PubMed 33458763Pai MP, Wilcox MH, Chitra S, McGovern PC. 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. J Antimicrob Chemother. 2021 Apr 13;76(5):1315-1322. doi: 10.1093/jac/dkaa558.
Derived from this study: PubMed 33326848Cornely OA, File TM Jr, Garrity-Ryan L, Chitra S, Noble R, McGovern PC. 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. Int J Antimicrob Agents. 2021 Feb;57(2):106263. doi: 10.1016/j.ijantimicag.2020.106263. Epub 2020 Dec 14.
Derived from this study: PubMed 31367742Abrahamian FM, Sakoulas G, Tzanis E, Manley A, Steenbergen J, Das AF, Eckburg PB, McGovern PC. Omadacycline for Acute Bacterial Skin and Skin Structure Infections. Clin Infect Dis. 2019 Aug 1;69(Suppl 1):S23-S32. doi: 10.1093/cid/ciz396.
Derived from this study: PubMed 30726689O'Riordan W, Green S, Overcash JS, Puljiz I, Metallidis S, Gardovskis J, Garrity-Ryan L, Das AF, Tzanis E, Eckburg PB, Manley A, Villano SA, Steenbergen JN, Loh E. Omadacycline for Acute Bacterial Skin and Skin-Structure Infections. N Engl J Med. 2019 Feb 7;380(6):528-538. doi: 10.1056/NEJMoa1800170.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

78 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omadacycline and Linezolid in people with Bacterial Infections and Skin Structures and Soft Tissue Infections, run by Paratek Pharmaceuticals Inc at 78 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Ukraine, Romania, Peru, Bulgaria and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Early Clinical Response (time frame: Screening; 48 to 72 hours after the first dose of test article). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02378480, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.