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

• Sponsor: Paratek Pharmaceuticals Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02378480
• Collaborator: (none)
• Enrollment: 655
• Locations: 78
• Arms: 2
• Duration (Months): 11
• Patients Per Site: 8.4
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Infections; Skin Structures and Soft Tissue Infections	Drug: Omadacycline; Drug: Linezolid	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 655 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Omadacycline Omadacycline IV; Omadacycline tablets	Drug: Omadacycline; Injection for IV dosing; Tablets for oral dosing
Active Comparator: Linezolid Linezolid IV; Linezolid tablets	Drug: Linezolid; Infusion solution for IV dosing; Tablets for oral dosing; Other Names: Zyvox

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site 261	Mobile	Alabama	United States	36608
2	Site 262	Chula Vista	California	United States	91911
3	Site 254	La Mesa	California	United States	91942
4	Site 258	Oceanside	California	United States	92056
5	Site 252	Santa Ana	California	United States	92705
6	Site 260	Santa Ana	California	United States	92705
7	Site 269	Stockton	California	United States	95204
8	Site 259	Miami	Florida	United States	33144
9	Site 264	West Palm Beach	Florida	United States	33407
10	Site 256	Augusta	Georgia	United States	30909
11	Site 253	Columbus	Georgia	United States	31904
12	Site 257	Springfield	Massachusetts	United States	01199
13	Site 268	Detroit	Michigan	United States	48202
14	Site 266	Butte	Montana	United States	59701
15	Site 263	Las Vegas	Nevada	United States	89119
16	Site 270	Somers Point	New Jersey	United States	08244
17	Site 273	Buffalo	New York	United States	14215
18	Site 255	Rapid City	South Dakota	United States	57702
19	Site 104	Pleven		Bulgaria
20	Site 102	Plovdiv		Bulgaria
21	Site 105	Plovdiv		Bulgaria
22	Site 103	Rousse		Bulgaria
23	Site 101	Sofia		Bulgaria
24	Site 205	Slavonski Brod		Croatia
25	Site 201	Zagreb		Croatia	10000
26	Site 203	Zagreb		Croatia	10000
27	Site 202	Zagreb		Croatia
28	Site 204	Zagreb		Croatia
29	Site 207	Athens		Greece
30	Site 211	Athens		Greece
31	Site 208	Thessaloniki		Greece
32	Site 209	Thessaloniki		Greece
33	Site 110	Budapest		Hungary
34	Site 111	Budapest		Hungary
35	Site 114	Miskolc		Hungary
36	Site 113	Szeged		Hungary
37	Site 213	Holon		Israel
38	Site 219	Kfar-Saba		Israel
39	Site 214	Nazareth		Israel
40	Site 216	Safed		Israel
41	Site 122	Daugavpils		Latvia
42	Site 123	Liepaja		Latvia
43	Site 124	Rezekne		Latvia
44	Site 120	Riga		Latvia
45	Site 121	Riga		Latvia
46	Site 234	Cusco		Peru
47	Site 233	Lima		Peru
48	Site 236	Lima		Peru
49	Site 238	Lima		Peru
50	Site 239	Lima		Peru
51	Site 237	Trujillo		Peru
52	Site 130	Bydgoszcz		Poland
53	Site 133	Katowice		Poland
54	Site 131	Lodz		Poland
55	Site 134	Olsztyn		Poland
56	Site 132	Warszawa		Poland
57	Site 141	Bucharest		Romania
58	Site 142	Bucharest		Romania
59	Site 146	Bucharest		Romania
60	Site 144	Cluj-Napoca		Romania
61	Site 140	Craiova		Romania
62	Site 145	Timisoara		Romania
63	Site 143	Târgu-Mureş		Romania
64	Site 241	Benoni	Gauteng	South Africa
65	Site 244	Thabazimbi	Limpopo	South Africa
66	Site 222	Terrassa	Barcelona	Spain
67	Site 221	Barcelona	Cataluna	Spain
68	Site 247	Ankara		Turkey
69	Site 246	Trabzon		Turkey
70	Site 172	Dnipropetrovsk		Ukraine
71	Site 173	Dnipropetrovsk		Ukraine
72	Site 179	Kharkiv		Ukraine
73	Site 171	Kyiv		Ukraine
74	Site 170	Lviv		Ukraine
75	Site 174	Odesa		Ukraine
76	Site 175	Uzhhorod		Ukraine
77	Site 178	Vinnytsia		Ukraine
78	Site 176	Zaporizhia		Ukraine

Sponsors and Collaborators

• Paratek Pharmaceuticals Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paratek Pharmaceuticals Inc
• ClinicalTrials.gov Identifier: NCT02378480
• Other Study ID Numbers: PTK0796-ABSI-1108
• First Posted: Mar 4, 2015
• Last Update Posted: Mar 21, 2019
• Last Verified: Mar 1, 2019

• Additional relevant MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Soft Tissue Infections; Linezolid

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Omadacycline	Linezolid
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	329	326
COMPLETED	301	294
NOT COMPLETED	28	32

Baseline Characteristics

Arm/Group Title	Omadacycline	Linezolid	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	323	322	645
Age, Customized (Count of Participants)
18-45 years	146 45.2%	154 47.8%	300 46.5%
>45-65 years	141 43.7%	136 42.2%	277 42.9%
>65 years	36 11.1%	32 9.9%	68 10.5%
Sex: Female, Male (Count of Participants)
Female	120 37.2%	109 33.9%	229 35.5%
Male	203 62.8%	213 66.1%	416 64.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	7 2.2%	5 1.6%	12 1.9%
Asian	1 0.3%	2 0.6%	3 0.5%
Native Hawaiian or Other Pacific Islander	1 0.3%	3 0.9%	4 0.6%
Black or African American	16 5%	8 2.5%	24 3.7%
White	294 91%	300 93.2%	594 92.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	4 1.2%	4 1.2%	8 1.2%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Early Clinical Response
Description	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.
Time Frame	Screening; 48 to 72 hours after the first dose of test article

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Omadacycline	Linezolid
Arm/Group Description	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.	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.
Measure Participants	316	311
Clinical success	268 83%	266 82.6%
Clinical failure	23 7.1%	19 5.9%
Indeterminate	25 7.7%	26 8.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omadacycline, Linezolid
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	A non-inferiority margin of 10% was used for the analysis.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	treatment difference
	Estimated Value	-0.7
	Confidence Interval	(2-Sided) 95%; -6.3 to 4.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.

2. Secondary Outcome

Title	Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit
Description	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.
Time Frame	Screening; 7 to 14 days after the last day of therapy

Outcome Measure Data

Analysis Population Description

mITT Population

Arm/Group Title	Omadacycline	Linezolid
Arm/Group Description	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.	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.
Measure Participants	316	311
Clinical success	272 84.2%	260 80.7%
Clinical failure	20 6.2%	27 8.4%
Indeterminate	24 7.4%	24 7.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omadacycline, Linezolid
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	A non-inferiority margin of 10% was used for the analysis.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	treatment difference
	Estimated Value	2.5
	Confidence Interval	(2-Sided) 95%; -3.2 to 8.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.

3. Secondary Outcome

Title	Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population
Description	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.
Time Frame	Screening; 7 to 14 days after the last day of therapy

Outcome Measure Data

Analysis Population Description

CE-PTE Population: all participants in the mITT Population meeting additional pre-defined criteria

Arm/Group Title	Omadacycline	Linezolid
Arm/Group Description	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.	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.
Measure Participants	269	260
Clinical success	259 80.2%	243 75.5%
Clinical failure	10 3.1%	17 5.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omadacycline, Linezolid
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	A non-inferiority margin of 10% was used for the analysis.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	treatment difference
	Estimated Value	2.8
	Confidence Interval	(2-Sided) 95%; -1.0 to 6.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.

4. Secondary Outcome

Title	Number of Participants With the Indicated Type of Adverse Event (AE)
Description	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.
Time Frame	0 to 37 days

Outcome Measure Data

Analysis Population Description

Safety Population: all randomized participants who received test article

Arm/Group Title	Omadacycline	Linezolid
Arm/Group Description	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.	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.
Measure Participants	323	322
AE	158 48.9%	157 48.8%
TEAE	156 48.3%	147 45.7%
Drug-releated AE	58 18%	59 18.3%
Severe TEAE	6 1.9%	10 3.1%
Serious TEAE	12 3.7%	8 2.5%
Drug-related serious TEAE	0 0%	0 0%
Serious TEAE leading to death	1 0.3%	2 0.6%
TEAE leading to premature drug discontinuation	6 1.9%	7 2.2%
TEAE leading to premature discontinuation of study	6 1.9%	7 2.2%
TEAE leading to dose interruption	2 0.6%	0 0%
Serious TEAEs leading to drug discontinuation	3 0.9%	3 0.9%

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).
Adverse Event Reporting Description	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.
Arm/Group Title	Omadacycline		Linezolid
Arm/Group Description	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.		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.
All Cause Mortality
	Omadacycline		Linezolid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/323 (0.3%)		2/322 (0.6%)
Serious Adverse Events
	Omadacycline		Linezolid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/323 (3.7%)		8/322 (2.5%)
Cardiac disorders
Cardiac Arrest	0/323 (0%)		1/322 (0.3%)
Cardiac Failure	0/323 (0%)		1/322 (0.3%)
General disorders
Non-Cardiac Chest Pain	1/323 (0.3%)		0/322 (0%)
Infections and infestations
Cellulitis	2/323 (0.6%)		1/322 (0.3%)
Subcutaneous Abscess	2/323 (0.6%)		0/322 (0%)
Wound Infection	2/323 (0.6%)		0/322 (0%)
Bacteraemia	1/323 (0.3%)		0/322 (0%)
Gastroenteritis Rotavirus	1/323 (0.3%)		0/322 (0%)
Sepsis	0/323 (0%)		1/322 (0.3%)
Injury, poisoning and procedural complications
Joint Dislocation	1/323 (0.3%)		0/322 (0%)
Overdose	1/323 (0.3%)		1/322 (0.3%)
Nervous system disorders
Hemiparesis	1/323 (0.3%)		0/322 (0%)
Psychiatric disorders
Drug Abuse	0/323 (0%)		1/322 (0.3%)
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease	0/323 (0%)		1/322 (0.3%)
Pulmonary Embolism	0/323 (0%)		1/322 (0.3%)
Other (Not Including Serious) Adverse Events
	Omadacycline		Linezolid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	104/323 (32.2%)		101/322 (31.4%)
Gastrointestinal disorders
Nausea	40/323 (12.4%)		32/322 (9.9%)
Vomiting	17/323 (5.3%)		16/322 (5%)
Diarrhea	7/323 (2.2%)		10/322 (3.1%)
General disorders
Infusion site extravasation	28/323 (8.7%)		19/322 (5.9%)
Infections and infestations
Subcutaneous abscess	16/323 (5%)		19/322 (5.9%)
Cellulitis	13/323 (4%)		14/322 (4.3%)
Wound infection	8/323 (2.5%)		5/322 (1.6%)
Investigations
Alanine aminotransferase increased	9/323 (2.8%)		14/322 (4.3%)
Aspartate aminotransferase increased	8/323 (2.5%)		12/322 (3.7%)
Nervous system disorders
Headache	10/323 (3.1%)		13/322 (4%)
Skin and subcutaneous tissue disorders
Pruritus	7/323 (2.2%)		0/322 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.