IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the T... | NCT03757234

NCT03757234

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Omadacycline 200 iv/200 iv	Experimental	On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.	Drug: Omadacycline
Omadacycline 200 iv/100 iv	Experimental	On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.	Drug: Omadacycline
Omadacycline 200 iv/300 po or 100 iv	Experimental	On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams per oral (po). All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.	Drug: Omadacycline
Omadacycline 200 iv/450 po or 100 iv	Experimental	On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.

Name	Type	Description	Arm Group Labels	Other Names
Omadacycline	Drug	po tablets	Omadacycline 200 iv/300 po or 100 iv Omadacycline 200 iv/450 po or 100 iv

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)	Clinical response was determined by the investigator at the PTE visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as the complete resolution or significant improvement of the baseline AP signs and symptoms at the PTE visit such that no additional antimicrobial therapy is required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection or reappearance of signs and symptoms at or before the PTE visit such that use of additional systemic antimicrobial therapy for the current infection was required or death at or before the PTE visit. The clinical outcome was deemed as Indeterminate when the PTE visit was not completed.	Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).
Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population)	Microbiological response was determined programmatically at the PTE visit by assessing whether or not the participant met the microbiological outcome of 'Success', 'Failure', or 'Indeterminate'. Participants were considered to have a microbiological response of 'Success' if the outcomes of each baseline pathogens were eradication at the PTE visit. Participants were considered to have a microbiological response of 'Failure' if the outcome for any pathogen was persistence. Participants were considered to have a microbiological response of 'Indeterminate', if the outcome of at least 1 baseline pathogen was indeterminate and there was no outcome of persistence for any baseline pathogen.	Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).
Number of Participants With Resolution of All AP Signs and Clinical Symptoms at PTE Visit (ITT Population)	Participants recorded their assessments using the Modified Patient Symptom Assessment Questionnaire (mPSAQ), a 6-item questionnaire that assessed the levels of 'severity' and 'bothersomeness' for six pyelonephritis signs and symptoms. The sub-scale responses were recorded as 'did not have', 'mild', 'moderate', and 'severe' for 'severity'; and 'not at all', 'a little', 'moderately', and 'a lot' for 'bothersomeness', both scored 0-3. Total scores were calculated by summing the non-missing scores of the 6 items, divided by the number of non-missing items, and then multiplied by 6. For each sub-scale, the total score ranged from 0 (least Severe/ least bothersome) and 18 (worst severity/most bothersome). Number of participants with resolution of all symptoms, without occurrence of new symptoms is reported. Resolution was defined as absence of all baseline symptoms.

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events	An adverse event is any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given a study drug or in a clinical study. A treatment-emergent adverse event was defined as any adverse event that newly appeared, increased in frequency, or worsened in severity on or after the initiation of the study drug.

Eligibility Module

Contacts/Locations Module

References Module

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No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Omadacycline 200 iv/200 iv	On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 26, 2018	Jun 8, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

The intent-to-treat (ITT) population consisted of all randomized participants regardless of whether or not the participant received study drug.

Arm/Group Information

ID	Title	Description
BG000	Omadacycline 200 iv/200 iv	On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.
BG001	Omadacycline 200 iv/100 iv	On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.
BG002	Omadacycline 200 iv/300 po or 100 iv	On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
BG003	Omadacycline 200 iv/450 po or 100 iv	On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
BG004	Levofloxacin 750 iv/750 po or iv	On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00038.2± 14.97 BG00133.9± 14.48 BG00237.1± 15.97 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00075 BG00118 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

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 an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)

Clinical response was determined by the investigator at the PTE visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as the complete resolution or significant improvement of the baseline AP signs and symptoms at the PTE visit such that no additional antimicrobial therapy is required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection or reappearance of signs and symptoms at or before the PTE visit such that use of additional systemic antimicrobial therapy for the current infection was required or death at or before the PTE visit. The clinical outcome was deemed as Indeterminate when the PTE visit was not completed.

The intent-to-treat (ITT) population consisted of all randomized participants regardless of whether or not the participant received study drug.

Posted

Count of Participants

Participants

Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).

ID	Title	Description
OG000	Omadacycline 200 iv/200 iv	On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.
OG001	Omadacycline 200 iv/100 iv	On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.
OG002	Omadacycline 200 iv/300 po or 100 iv	On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
OG003	Omadacycline 200 iv/450 po or 100 iv	On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
OG004	Levofloxacin 750 iv/750 po or iv	On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.

Units	Counts
Participants	OG00075 OG00118 OG00217 OG003

Title

Denominators

Categories

Clinical Success

Title	Measurements
	OG00068 OG00115 OG00215 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG004						Treatment difference	-2.6			2-Sided	95	-12.4	6.9			Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.		Non-Inferiority	Non-inferiority margin for comparison of the doses was set at 10%.

Primary

Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population)

Microbiological response was determined programmatically at the PTE visit by assessing whether or not the participant met the microbiological outcome of 'Success', 'Failure', or 'Indeterminate'. Participants were considered to have a microbiological response of 'Success' if the outcomes of each baseline pathogens were eradication at the PTE visit. Participants were considered to have a microbiological response of 'Failure' if the outcome for any pathogen was persistence. Participants were considered to have a microbiological response of 'Indeterminate', if the outcome of at least 1 baseline pathogen was indeterminate and there was no outcome of persistence for any baseline pathogen.

The micro-ITT population consisted of participants in the ITT population who had an appropriately collected pretreatment baseline urine culture with at least 1 uropathogen at ≥10^5 colony forming unit (CFU)/mL and not more than 2 bacterial isolates at any colony count.

Posted

Count of Participants

Participants

Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).

ID	Title	Description
OG000	Omadacycline 200 iv/200 iv	On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.
OG001

Primary

Number of Participants With Resolution of All AP Signs and Clinical Symptoms at PTE Visit (ITT Population)

Participants recorded their assessments using the Modified Patient Symptom Assessment Questionnaire (mPSAQ), a 6-item questionnaire that assessed the levels of 'severity' and 'bothersomeness' for six pyelonephritis signs and symptoms. The sub-scale responses were recorded as 'did not have', 'mild', 'moderate', and 'severe' for 'severity'; and 'not at all', 'a little', 'moderately', and 'a lot' for 'bothersomeness', both scored 0-3. Total scores were calculated by summing the non-missing scores of the 6 items, divided by the number of non-missing items, and then multiplied by 6. For each sub-scale, the total score ranged from 0 (least Severe/ least bothersome) and 18 (worst severity/most bothersome). Number of participants with resolution of all symptoms, without occurrence of new symptoms is reported. Resolution was defined as absence of all baseline symptoms.

The ITT population consisted of all randomized participants regardless of whether or not the participant received study drug. Participants who completed the PTE visit with evaluable data were analyzed for this end point.

Posted

Count of Participants

Participants

Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).

ID	Title	Description
OG000	Omadacycline 200 iv/200 iv	On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.

Primary

Number of Participants With No Worsening and Absence of New AP Signs and Clinical Symptoms at PTE Visit (ITT Population)

Participants recorded their assessments using the mPSAQ, a 6-item questionnaire that assessed the levels of 'severity' and 'bothersomeness' for six pyelonephritis signs and symptoms. The sub-scale responses were recorded as 'did not have', 'mild', 'moderate', and 'severe' for 'severity'; and 'not at all', 'a little', 'moderately', and 'a lot' for 'bothersomeness', both scored 0-3. Total scores were calculated by summing the non-missing scores of the 6 items, divided by the number of non-missing items, and then multiplied by 6. For each sub-scale, the total score ranged from 0 (least Severe/ least bothersome) and 18 (worst severity/most bothersome). Number of participants with no worsening and absence of AP signs and clinical symptoms is reported. No worsening meant that each question score is same or better at post baseline.

Posted

Count of Participants

Participants

Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).

ID	Title	Description
OG000	Omadacycline 200 iv/200 iv	On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.

Secondary

Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events

An adverse event is any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given a study drug or in a clinical study. A treatment-emergent adverse event was defined as any adverse event that newly appeared, increased in frequency, or worsened in severity on or after the initiation of the study drug.

The Safety population consisted of all randomized participants who received at least one dose of study drug.

Posted

Count of Participants

Participants

up to approximately 28 days

ID	Title	Description
OG000	Omadacycline 200 iv/200 iv	On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.
OG001	Omadacycline 200 iv/100 iv	On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Omadacycline 200 iv/200 iv	On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.	75	0	75	21	75
EG001	Omadacycline 200 iv/100 iv	On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.	18	0	18	6	18
EG002	Omadacycline 200 iv/300 po or 100 iv	On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.	17	2	17	7	17
EG003	Omadacycline 200 iv/450 po or 100 iv	On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.	17	2	17	8	17
EG004	Levofloxacin 750 iv/750 po or iv	On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.	74	2	74	16	74

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Renal abscess	Infections and infestations	MedDra 20.1	Systematic Assessment	EG0000 events0 affected75 at risk EG0010 events0 affected18 at risk EG0021 events1 affected17 at risk EG0030 events0 affected17 at risk EG0040 events0 affected74 at risk
Pyelonephritis acute	Infections and infestations	MedDra 20.1	Systematic Assessment	EG0000 events0 affected75 at risk EG0010 events0 affected18 at risk EG0021 events1 affected17 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDra 20.1	Systematic Assessment	EG0000 events0 affected75 at risk EG0010 events0 affected18 at risk EG0020 events0 affected17 at risk EG003
Pneumonia	Infections and infestations	MedDra 20.1	Systematic Assessment	EG0000 events0 affected75 at risk EG0010 events0 affected18 at risk EG0020 events0 affected17 at risk EG003
Escherichia bacteraemia	Infections and infestations	MedDra 20.1	Systematic Assessment	EG0000 events0 affected75 at risk EG0010 events0 affected18 at risk EG0020 events0 affected17 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDra 20.1	Systematic Assessment	EG0000 events0 affected75 at risk EG0010 events0 affected18 at risk EG0020 events0 affected17 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Tachycardia	Cardiac disorders	MedDra 20.1	Systematic Assessment	EG0000 affected75 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG0031 affected17 at risk EG0040 affected74 at risk
Diarrhoea	Gastrointestinal disorders	MedDra 20.1	Systematic Assessment	EG0001 affected75 at risk EG0011 affected18 at risk EG0020 affected17 at risk EG003
Nausea	Gastrointestinal disorders	MedDra 20.1	Systematic Assessment	EG0003 affected75 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Vomiting	Gastrointestinal disorders	MedDra 20.1	Systematic Assessment	EG0000 affected75 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Asthenia	General disorders	MedDra 20.1	Systematic Assessment	EG0002 affected75 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Hyperthermia	General disorders	MedDra 20.1	Systematic Assessment	EG0000 affected75 at risk EG0011 affected18 at risk EG0020 affected17 at risk EG003
Asymptomatic bacteriuria	Infections and infestations	MedDra 20.1	Systematic Assessment	EG0003 affected75 at risk EG0012 affected18 at risk EG0022 affected17 at risk EG003
Oral herpes	Infections and infestations	MedDra 20.1	Systematic Assessment	EG0000 affected75 at risk EG0010 affected18 at risk EG0021 affected17 at risk EG003
Pharyngitis	Infections and infestations	MedDra 20.1	Systematic Assessment	EG0000 affected75 at risk EG0011 affected18 at risk EG0020 affected17 at risk EG003
Viral rhinitis	Infections and infestations	MedDra 20.1	Systematic Assessment	EG0000 affected75 at risk EG0010 affected18 at risk EG0021 affected17 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	MedDra 20.1	Systematic Assessment	EG0000 affected75 at risk EG0010 affected18 at risk EG0021 affected17 at risk EG003
Alanine aminotransferase increased	Investigations	MedDra 20.1	Systematic Assessment	EG0001 affected75 at risk EG0011 affected18 at risk EG0020 affected17 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDra 20.1	Systematic Assessment	EG0000 affected75 at risk EG0011 affected18 at risk EG0020 affected17 at risk EG003
Body temperature increased	Investigations	MedDra 20.1	Systematic Assessment	EG0000 affected75 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDra 20.1	Systematic Assessment	EG0000 affected75 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Dizziness	Nervous system disorders	MedDra 20.1	Systematic Assessment	EG0003 affected75 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Dysgeusia	Nervous system disorders	MedDra 20.1	Systematic Assessment	EG0000 affected75 at risk EG0010 affected18 at risk EG0021 affected17 at risk EG003
Headache	Nervous system disorders	MedDra 20.1	Systematic Assessment	EG0008 affected75 at risk EG0010 affected18 at risk EG0022 affected17 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDra 20.1	Systematic Assessment	EG0000 affected75 at risk EG0010 affected18 at risk EG0022 affected17 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDra 20.1	Systematic Assessment	EG0002 affected75 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDra 20.1	Systematic Assessment	EG0003 affected75 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDra 20.1	Systematic Assessment	EG0002 affected75 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Hypertension	Vascular disorders	MedDra 20.1	Systematic Assessment	EG0000 affected75 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003

In May 2019, the DMC modified the randomization algorithm based on their review of the data. After this change, participants were randomized in a 1:1 ratio to either the omadacycline 200 iv/200 iv or levofloxacin arms.

Certain Agreements

First MCP Posted Date

ID	Term
C000591640	omadacycline
D064704	Levofloxacin

Ancestor Terms

ID	Term
D015242	Ofloxacin
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

EG0040 events0 affected74 at risk

EG0041 events1 affected74 at risk

EG0040 events0 affected74 at risk

EG0041 events1 affected74 at risk

EG0045 affected74 at risk

EG0041 affected74 at risk

EG0040 affected74 at risk

EG0041 affected74 at risk

EG0040 affected74 at risk

EG0041 affected74 at risk

EG0040 affected74 at risk

EG0045 affected74 at risk

EG0040 affected74 at risk

EG0041 affected74 at risk

Facility	Status	City	State	ZIP	Country	Contacts
Site 201		Tbilisi			Georgia
Site 202