Trial Outcomes & Findings for IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis (NCT NCT03757234)
NCT ID: NCT03757234
Last Updated: 2020-07-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
201 participants
Primary outcome timeframe
Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).
Results posted on
2020-07-07
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
75
|
18
|
17
|
17
|
74
|
|
Overall Study
Completed PTE Visit
|
72
|
16
|
17
|
16
|
71
|
|
Overall Study
COMPLETED
|
72
|
16
|
17
|
16
|
70
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
0
|
1
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
1
|
2
|
|
Overall Study
Other
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis
Baseline characteristics by cohort
| Measure |
Omadacycline 200 iv/200 iv
n=75 Participants
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.
|
Omadacycline 200 iv/100 iv
n=18 Participants
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.
|
Omadacycline 200 iv/300 po or 100 iv
n=17 Participants
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.
|
Omadacycline 200 iv/450 po or 100 iv
n=17 Participants
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.
|
Levofloxacin 750 iv/750 po or iv
n=74 Participants
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.
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.2 years
STANDARD_DEVIATION 14.97 • n=5 Participants
|
33.9 years
STANDARD_DEVIATION 14.48 • n=7 Participants
|
37.1 years
STANDARD_DEVIATION 15.97 • n=5 Participants
|
38.2 years
STANDARD_DEVIATION 17.66 • n=4 Participants
|
38.8 years
STANDARD_DEVIATION 14.74 • n=21 Participants
|
37.9 years
STANDARD_DEVIATION 15.07 • n=8 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
201 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
200 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
200 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).Population: The intent-to-treat (ITT) population consisted of all randomized participants regardless of whether or not the participant received study drug.
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.
Outcome measures
| Measure |
Omadacycline 200 iv/200 iv
n=75 Participants
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.
|
Omadacycline 200 iv/100 iv
n=18 Participants
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.
|
Omadacycline 200 iv/300 po or 100 iv
n=17 Participants
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.
|
Omadacycline 200 iv/450 po or 100 iv
n=17 Participants
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.
|
Levofloxacin 750 iv/750 po or iv
n=74 Participants
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.
|
|---|---|---|---|---|---|
|
Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)
Clinical Success
|
68 Participants
|
15 Participants
|
15 Participants
|
16 Participants
|
69 Participants
|
|
Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)
Clinical Failure
|
5 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)
Indeterminate
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).Population: 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.
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.
Outcome measures
| Measure |
Omadacycline 200 iv/200 iv
n=46 Participants
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.
|
Omadacycline 200 iv/100 iv
n=11 Participants
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.
|
Omadacycline 200 iv/300 po or 100 iv
n=14 Participants
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.
|
Omadacycline 200 iv/450 po or 100 iv
n=13 Participants
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.
|
Levofloxacin 750 iv/750 po or iv
n=52 Participants
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.
|
|---|---|---|---|---|---|
|
Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population)
Clinical Success
|
32 Participants
|
3 Participants
|
9 Participants
|
5 Participants
|
39 Participants
|
|
Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population)
Clinical Failure
|
13 Participants
|
7 Participants
|
5 Participants
|
7 Participants
|
11 Participants
|
|
Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population)
Indeterminate
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).Population: 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.
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.
Outcome measures
| Measure |
Omadacycline 200 iv/200 iv
n=64 Participants
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.
|
Omadacycline 200 iv/100 iv
n=16 Participants
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.
|
Omadacycline 200 iv/300 po or 100 iv
n=16 Participants
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.
|
Omadacycline 200 iv/450 po or 100 iv
n=16 Participants
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.
|
Levofloxacin 750 iv/750 po or iv
n=66 Participants
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.
|
|---|---|---|---|---|---|
|
Number of Participants With Resolution of All AP Signs and Clinical Symptoms at PTE Visit (ITT Population)
|
51 Participants
|
15 Participants
|
14 Participants
|
13 Participants
|
54 Participants
|
PRIMARY outcome
Timeframe: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).Population: 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.
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.
Outcome measures
| Measure |
Omadacycline 200 iv/200 iv
n=64 Participants
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.
|
Omadacycline 200 iv/100 iv
n=16 Participants
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.
|
Omadacycline 200 iv/300 po or 100 iv
n=16 Participants
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.
|
Omadacycline 200 iv/450 po or 100 iv
n=16 Participants
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.
|
Levofloxacin 750 iv/750 po or iv
n=66 Participants
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.
|
|---|---|---|---|---|---|
|
Number of Participants With No Worsening and Absence of New AP Signs and Clinical Symptoms at PTE Visit (ITT Population)
|
62 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: up to approximately 28 daysPopulation: The Safety population consisted of all randomized participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
Omadacycline 200 iv/200 iv
n=75 Participants
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.
|
Omadacycline 200 iv/100 iv
n=18 Participants
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.
|
Omadacycline 200 iv/300 po or 100 iv
n=17 Participants
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.
|
Omadacycline 200 iv/450 po or 100 iv
n=17 Participants
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.
|
Levofloxacin 750 iv/750 po or iv
n=74 Participants
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.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Treatment Emergent Adverse Events
|
23 Participants
|
6 Participants
|
9 Participants
|
8 Participants
|
24 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Treatment Emergent Serious Adverse Events
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Omadacycline 200 iv/200 iv
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Omadacycline 200 iv/100 iv
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Omadacycline 200 iv/300 po or 100 iv
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Omadacycline 200 iv/450 po or 100 iv
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Levofloxacin 750 iv/750 po or iv
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Omadacycline 200 iv/200 iv
n=75 participants at risk
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.
|
Omadacycline 200 iv/100 iv
n=18 participants at risk
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.
|
Omadacycline 200 iv/300 po or 100 iv
n=17 participants at risk
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.
|
Omadacycline 200 iv/450 po or 100 iv
n=17 participants at risk
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.
|
Levofloxacin 750 iv/750 po or iv
n=74 participants at risk
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.
|
|---|---|---|---|---|---|
|
Infections and infestations
Renal abscess
|
0.00%
0/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
1.4%
1/74 • Number of events 1 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
1.4%
1/74 • Number of events 1 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Omadacycline 200 iv/200 iv
n=75 participants at risk
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.
|
Omadacycline 200 iv/100 iv
n=18 participants at risk
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.
|
Omadacycline 200 iv/300 po or 100 iv
n=17 participants at risk
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.
|
Omadacycline 200 iv/450 po or 100 iv
n=17 participants at risk
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.
|
Levofloxacin 750 iv/750 po or iv
n=74 participants at risk
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.
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.7%
2/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.9%
1/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
1/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.6%
1/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.9%
1/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
6.8%
5/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
3/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
23.5%
4/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
6.8%
5/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.9%
1/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
1.4%
1/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
2.7%
2/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
1.4%
1/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
General disorders
Hyperthermia
|
0.00%
0/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.6%
1/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
4.0%
3/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
11.1%
2/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
11.8%
2/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.9%
1/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
1.4%
1/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.9%
1/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.6%
1/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.9%
1/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.9%
1/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
1.3%
1/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.6%
1/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.6%
1/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Investigations
Body temperature increased
|
0.00%
0/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.9%
1/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
1.4%
1/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.9%
1/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
4.0%
3/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.9%
1/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
10.7%
8/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
11.8%
2/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
17.6%
3/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
6.8%
5/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
11.8%
2/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.7%
2/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
4.0%
3/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/75 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/18 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
5.9%
1/17 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
1.4%
1/74 • Up to approximately 28 days
The Safety Population consisted of all randomized participants who received at least one dose of study drug.
|
Additional Information
Paratek Medical Information
Paratek Pharmaceuticals, Inc.
Phone: 1-833-727-2835
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER