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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omadacycline | Experimental | Omadacycline IV; Omadacycline tablets |
|
| Linezolid | Active Comparator | Linezolid IV; Linezolid tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omadacycline | Drug | Injection for IV dosing; Tablets for oral dosing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Screening; 48 to 72 hours after the first dose of test article |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 261 | Mobile | Alabama | 36608 | United States | ||
| Site 262 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39461915 | Derived | 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. | |
| 35776862 | Derived |
Not provided
Not provided
Participants who met inclusion criteria and did not meet exclusion criteria were randomly assigned to a treatment group, and received their first dose of test article within 4 hours after randomization. All participants were expected to present with ABSSSI severe enough to require a minimum of at least 3 days of intravenous treatment.
The study was designed to enroll adult participants with Acute Bacterial Skin and Skin Structure Infection (ABSSSI) that was known or suspected to be due to a Gram-positive pathogen(s). Randomization was stratified across treatment groups by type of infection (wound infection, cellulitis/erysipelas, and major abscess) and geographic region.
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| ID | Title | Description |
|---|---|---|
| FG000 | Omadacycline | Participants received intravenous (IV) omadacycline 100 milligrams (mg) every 12 hours (q12h) (2 doses), followed by 100 mg IV every 24 hours (q24h) (starting 24 hours after the first dose), with the option to switch to a 300 mg oral administration q24h after a minimum of 3 days (6 doses) of IV treatment (6 overall IV doses because of the blinding). Participants received 4 active doses plus 2 placebo doses to maintain the blind. The total treatment duration was 7 to 14 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Linezolid |
| Drug |
Infusion solution for IV dosing; Tablets for oral dosing |
|
|
| 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. | 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. | 0 to 37 days |
| Chula Vista |
| California |
| 91911 |
| United States |
| Site 254 | La Mesa | California | 91942 | United States |
| Site 258 | Oceanside | California | 92056 | United States |
| Site 252 | Santa Ana | California | 92705 | United States |
| Site 260 | Santa Ana | California | 92705 | United States |
| Site 269 | Stockton | California | 95204 | United States |
| Site 259 | Miami | Florida | 33144 | United States |
| Site 264 | West Palm Beach | Florida | 33407 | United States |
| Site 256 | Augusta | Georgia | 30909 | United States |
| Site 253 | Columbus | Georgia | 31904 | United States |
| Site 257 | Springfield | Massachusetts | 01199 | United States |
| Site 268 | Detroit | Michigan | 48202 | United States |
| Site 266 | Butte | Montana | 59701 | United States |
| Site 263 | Las Vegas | Nevada | 89119 | United States |
| Site 270 | Somers Point | New Jersey | 08244 | United States |
| Site 273 | Buffalo | New York | 14215 | United States |
| Site 255 | Rapid City | South Dakota | 57702 | United States |
| Site 104 | Pleven | Bulgaria |
| Site 102 | Plovdiv | Bulgaria |
| Site 105 | Plovdiv | Bulgaria |
| Site 103 | Rousse | Bulgaria |
| Site 101 | Sofia | Bulgaria |
| Site 205 | Slavonski Brod | Croatia |
| Site 201 | Zagreb | 10000 | Croatia |
| Site 203 | Zagreb | 10000 | Croatia |
| Site 202 | Zagreb | Croatia |
| Site 204 | Zagreb | Croatia |
| Site 207 | Athens | Greece |
| Site 211 | Athens | Greece |
| Site 208 | Thessaloniki | Greece |
| Site 209 | Thessaloniki | Greece |
| Site 110 | Budapest | Hungary |
| Site 111 | Budapest | Hungary |
| Site 114 | Miskolc | Hungary |
| Site 113 | Szeged | Hungary |
| Site 213 | Holon | Israel |
| Site 219 | Kfar Saba | Israel |
| Site 214 | Nazareth | Israel |
| Site 216 | Safed | Israel |
| Site 122 | Daugavpils | Latvia |
| Site 123 | Liepāja | Latvia |
| Site 124 | Rēzekne | Latvia |
| Site 120 | Riga | Latvia |
| Site 121 | Riga | Latvia |
| Site 234 | Cusco | Peru |
| Site 233 | Lima | Peru |
| Site 236 | Lima | Peru |
| Site 238 | Lima | Peru |
| Site 239 | Lima | Peru |
| Site 237 | Trujillo | Peru |
| Site 130 | Bydgoszcz | Poland |
| Site 133 | Katowice | Poland |
| Site 131 | Lodz | Poland |
| Site 134 | Olsztyn | Poland |
| Site 132 | Warsaw | Poland |
| Site 141 | Bucharest | Romania |
| Site 142 | Bucharest | Romania |
| Site 146 | Bucharest | Romania |
| Site 144 | Cluj-Napoca | Romania |
| Site 140 | Craiova | Romania |
| Site 143 | Târgu Mureş | Romania |
| Site 145 | Timișoara | Romania |
| Site 241 | Benoni | Gauteng | South Africa |
| Site 244 | Thabazimbi | Limpopo | South Africa |
| Site 222 | Terrassa | Barcelona | Spain |
| Site 221 | Barcelona | Catalonia | Spain |
| Site 247 | Ankara | Turkey (Türkiye) |
| Site 246 | Trabzon | Turkey (Türkiye) |
| Site 172 | Dnipropetrovsk | Ukraine |
| Site 173 | Dnipropetrovsk | Ukraine |
| Site 179 | Kharkiv | Ukraine |
| Site 171 | Kyiv | Ukraine |
| Site 170 | Lviv | Ukraine |
| Site 174 | Odesa | Ukraine |
| Site 175 | Uzhhorod | Ukraine |
| Site 178 | Vinnytsia | Ukraine |
| Site 176 | Zaporizhia | Ukraine |
| 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. |
| 33458763 | Derived | 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. |
| 33326848 | Derived | 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. |
| 31367742 | Derived | 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. |
| 30726689 | Derived | 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. |
| FG001 | Linezolid | Participants received linezolid 600 mg IV q12h with the option to switch to a 600 mg oral administration q12h after a minimum of 3 days (6 doses) of IV treatment. The total treatment duration was 7 to 14 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population: all randomized participants who received test article
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Omadacycline | Participants received intravenous (IV) omadacycline 100 milligrams (mg) every 12 hours (q12h) (2 doses), followed by 100 mg IV every 24 hours (q24h) (starting 24 hours after the first dose), with the option to switch to a 300 mg oral administration q24h after a minimum of 3 days (6 doses) of IV treatment (6 overall IV doses because of the blinding). Participants received 4 active doses plus 2 placebo doses to maintain the blind. The total treatment duration was 7 to 14 days. |
| BG001 | Linezolid | Participants received linezolid 600 mg IV q12h with the option to switch to a 600 mg oral administration q12h after a minimum of 3 days (6 doses) of IV treatment. The total treatment duration was 7 to 14 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Modified Intent-to-Treat (mITT) Population: all randomized participants without a baseline sole Gram-negative ABSSSI pathogen | Posted | Count of Participants | Participants | Screening; 48 to 72 hours after the first dose of test article |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | mITT Population | Posted | Count of Participants | Participants | Screening; 7 to 14 days after the last day of therapy |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | CE-PTE Population: all participants in the mITT Population meeting additional pre-defined criteria | Posted | Count of Participants | Participants | Screening; 7 to 14 days after the last day of therapy |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety Population: all randomized participants who received test article | Posted | Count of Participants | Participants | 0 to 37 days |
|
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).
Adverse events are reported for members of the Safety Population, comprised of all randomized participants who received test article. Safety assessments included clinical review of reported adverse events and serious adverse events (SAEs). Treatment-emergent adverse events, defined as events occurring after the first dose of active test article, are reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omadacycline | Participants received intravenous (IV) omadacycline 100 milligrams (mg) every 12 hours (q12h) (2 doses), followed by 100 mg IV every 24 hours (q24h) (starting 24 hours after the first dose), with the option to switch to a 300 mg oral administration q24h after a minimum of 3 days (6 doses) of IV treatment (6 overall IV doses because of the blinding). Participants received 4 active doses plus 2 placebo doses to maintain the blind. The total treatment duration was 7 to 14 days. | 1 | 323 | 12 | 323 | 104 | 323 |
| EG001 | Linezolid | Participants received linezolid 600 mg IV q12h with the option to switch to a 600 mg oral administration q12h after a minimum of 3 days (6 doses) of IV treatment. The total treatment duration was 7 to 14 days. | 2 | 322 | 8 | 322 | 101 | 322 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Subcutaneous Abscess | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Gastroenteritis Rotavirus | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Joint Dislocation | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Drug Abuse | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
The only disclosure restriction on the Principal Investigator is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor can request changes to the communication and require the removal of confidential information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul McGovern; Vice President, Clinical Affairs | Paratek Pharmaceuticals, Inc. | 484-751-4935 | Paul.Mcgovern@paratekpharma.com |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D018461 | Soft Tissue Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591640 | omadacycline |
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| >65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Indeterminate |
|
| OG001 | Linezolid | Participants received linezolid 600 mg IV q12h with the option to switch to a 600 mg oral administration q12h after a minimum of 3 days (6 doses) of IV treatment. The total treatment duration was 7 to 14 days. |
|
|
|
| OG001 | Linezolid | Participants received linezolid 600 mg IV q12h with the option to switch to a 600 mg oral administration q12h after a minimum of 3 days (6 doses) of IV treatment. The total treatment duration was 7 to 14 days. |
|
|
|
| OG001 | Linezolid | Participants received linezolid 600 mg IV q12h with the option to switch to a 600 mg oral administration q12h after a minimum of 3 days (6 doses) of IV treatment. The total treatment duration was 7 to 14 days. |
|
|