Trial Outcomes & Findings for Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections (NCT NCT01978938)

NCT ID: NCT01978938

Last Updated: 2022-01-11

Results Overview

This was the primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to levofloxacin in responder outcome, which was derived from both clinical and microbiological responses, in the micro-ITT population. Clinical responses were either cure, failure, or indeterminate/missing; microbiological responses were characterized programmatically as either success, failure, or indeterminate/missing. Clinical cure was defined as complete resolution or significant improvement of signs or symptoms of the infection; microbiological success was a reduction of the baseline pathogen(s) to \<10\^4 colony-forming units/milliliter (CFU/mL). An outcome of Responder required a clinical response of cure and a microbiological response of success. Any other combination of the clinical and microbiological responses was considered either Non-responder or Indeterminate.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

908 participants

Primary outcome timeframe

PT Visit

Results posted on

2022-01-11

Participant Flow

Participants with a diagnosis of complicated urinary tract infection (cUTI), including participants with acute pyelonephritis, were recruited into this study.

Screening and baseline assessments were performed after informed consent was obtained and within 36 hours prior to enrollment.

Participant milestones

Participant milestones
Measure	Eravacycline Eravacycline was administered intravenously (IV) at a dose of 1.5 milligrams per kilogram (mg/kg) of body weight every 24 hours (q24h). At minimum, the first 3 doses were administered IV. After an IV-to-oral (PO) transition, provided adequate clinical improvement, participants were administered 200 mg PO twice a day (BID) for a total therapy of 7 dosing cycles.	Levofloxacin Levofloxacin (750 mg) was administered IV q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 750 mg PO once a day (QD) for a total therapy of 7 dosing cycles.
Overall Study STARTED	455	453
Overall Study Received at Least 1 Dose of Study Drug	454	451
Overall Study COMPLETED	432	439
Overall Study NOT COMPLETED	23	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Eravacycline Eravacycline was administered intravenously (IV) at a dose of 1.5 milligrams per kilogram (mg/kg) of body weight every 24 hours (q24h). At minimum, the first 3 doses were administered IV. After an IV-to-oral (PO) transition, provided adequate clinical improvement, participants were administered 200 mg PO twice a day (BID) for a total therapy of 7 dosing cycles.	Levofloxacin Levofloxacin (750 mg) was administered IV q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 750 mg PO once a day (QD) for a total therapy of 7 dosing cycles.
Overall Study Lost to Follow-up	12	6
Overall Study Withdrawal by Subject	8	4
Overall Study Adverse Event, non-fatal	2	1
Overall Study Participant noncompliance	1	1
Overall Study Did not meet inclusion criteria	0	1
Overall Study Previously scheduled procedure	0	1

Baseline Characteristics

Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eravacycline n=455 Participants Eravacycline was administered IV at a dose of 1.5 mg/kg of body weight q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 200 mg PO BID for a total therapy of 7 dosing cycles.	Levofloxacin n=453 Participants Levofloxacin (750 mg) was administered IV q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 750 mg PO QD for a total therapy of 7 dosing cycles.	Total n=908 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	291 Participants n=99 Participants	301 Participants n=107 Participants	592 Participants n=206 Participants
Age, Categorical >=65 years	164 Participants n=99 Participants	152 Participants n=107 Participants	316 Participants n=206 Participants
Age, Continuous	53.7 years STANDARD_DEVIATION 18.82 • n=99 Participants	51.7 years STANDARD_DEVIATION 19.81 • n=107 Participants	52.7 years STANDARD_DEVIATION 19.3 • n=206 Participants
Sex: Female, Male Female	291 Participants n=99 Participants	302 Participants n=107 Participants	593 Participants n=206 Participants
Sex: Female, Male Male	164 Participants n=99 Participants	151 Participants n=107 Participants	315 Participants n=206 Participants

PRIMARY outcome

Timeframe: PT Visit

Population: micro-ITT included all participants in the ITT population who had at least 1 baseline bacterial pathogen from a urine or blood culture that caused a urinary tract infection (UTI) against which eravacycline had expected antibacterial activity. ITT included all randomized participants, regardless of receiving study drug or not.

Outcome measures

Outcome measures
Measure	Eravacycline n=298 Participants Eravacycline was administered IV at a dose of 1.5 mg/kg of body weight q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 200 mg PO BID for a total therapy of 7 dosing cycles.	Levofloxacin n=302 Participants Levofloxacin (750 mg) was administered IV q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 750 mg PO QD for a total therapy of 7 dosing cycles.
Participants In The Microbiological Intent-To-Treat (Micro-ITT) Population With A Responder Outcome At The Post-Treatment (PT) Visit Responder	180 Participants	202 Participants
Participants In The Microbiological Intent-To-Treat (Micro-ITT) Population With A Responder Outcome At The Post-Treatment (PT) Visit Non-responder	100 Participants	91 Participants
Participants In The Microbiological Intent-To-Treat (Micro-ITT) Population With A Responder Outcome At The Post-Treatment (PT) Visit Indeterminate	18 Participants	9 Participants

SECONDARY outcome

Timeframe: PT Visit

Population: micro-MITT included all micro-ITT participants who received ≥1 dose of study drug. micro-ITT: all ITT participants with ≥1 baseline bacterial pathogen from a urine or blood culture that caused a UTI against which eravacycline had expected antibacterial activity. ITT: all randomized participants, regardless of receiving study drug or not.

This outcome measure (FDA and the European Medicines Agency \[EMA\]) compared the microbiological responses of eravacycline to levofloxacin for both treatment groups in the micro-MITT population. Responses were success, failure, or indeterminate/missing. Success was considered a reduction of the baseline pathogen(s) to \<10\^4 CFU/mL. Failure required blood cultures at or beyond end of therapy (EOT) to be positive for baseline pathogen(s), or urine culture to grow ≥10\^4 CFU/mL of the baseline pathogen(s). Indeterminate/missing indicated no interpretable culture data available.

Outcome measures

Outcome measures
Measure	Eravacycline n=297 Participants Eravacycline was administered IV at a dose of 1.5 mg/kg of body weight q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 200 mg PO BID for a total therapy of 7 dosing cycles.	Levofloxacin n=302 Participants Levofloxacin (750 mg) was administered IV q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 750 mg PO QD for a total therapy of 7 dosing cycles.
Participants In The Microbiological Modified ITT (Micro-MITT) Population With A Microbiological Response Success	194 Participants	213 Participants
Participants In The Microbiological Modified ITT (Micro-MITT) Population With A Microbiological Response Failure	85 Participants	78 Participants
Participants In The Microbiological Modified ITT (Micro-MITT) Population With A Microbiological Response Indeterminate/missing	18 Participants	11 Participants

SECONDARY outcome

Timeframe: PT Visit

Population: ME: all micro-ITT and CE participants with a suitable urine specimen and an interpretable urine culture. CE: all randomized participants dosed with no other antimicrobials (unless allowed by protocol), had an investigator clinical response assessment of "success" or "failure" at the assessment visit, and had no other major protocol violations.

This outcome measure (FDA and EMA) compared the microbiological responses of eravacycline to levofloxacin for both treatment groups in the ME population. Responses were either success or failure. Indeterminate/missing responses were not included. Success was considered a reduction of the baseline pathogen(s) to \<10\^4 CFU/mL. Failure required blood cultures at or beyond EOT to be positive for baseline pathogen(s), or urine culture to grow ≥10\^4 CFU/mL of the baseline pathogen(s). Indeterminate/missing indicated no interpretable culture data available. Populations: ME, all micro-ITT and clinically-evaluable (CE) participants with a suitable urine specimen and an interpretable urine culture; micro-ITT, all participants with ≥1 baseline bacterial pathogen from a urine or blood culture that caused a UTI against which eravacycline had expected antibacterial activity; ITT, all randomized participants, regardless of receiving study drug or not.

Outcome measures

Outcome measures
Measure	Eravacycline n=255 Participants Eravacycline was administered IV at a dose of 1.5 mg/kg of body weight q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 200 mg PO BID for a total therapy of 7 dosing cycles.	Levofloxacin n=276 Participants Levofloxacin (750 mg) was administered IV q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 750 mg PO QD for a total therapy of 7 dosing cycles.
Participants In The Microbiologically Evaluable (ME) Population With A Microbiological Response Success	180 Participants	203 Participants
Participants In The Microbiologically Evaluable (ME) Population With A Microbiological Response Failure	75 Participants	73 Participants

Adverse Events

Eravacycline

Serious events: 7 serious events

Other events: 129 other events

Deaths: 1 deaths

Levofloxacin

Serious events: 6 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Eravacycline n=455 participants at risk Eravacycline was administered IV at a dose of 1.5 mg/kg of body weight q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 200 mg PO BID for a total therapy of 7 dosing cycles.	Levofloxacin n=450 participants at risk Levofloxacin (750 mg) was administered IV q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 750 mg PO QD for a total therapy of 7 dosing cycles.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.22% 1/455 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450	0.00% 0/450 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450
Cardiac disorders Pericardial effusion	0.00% 0/455 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450	0.22% 1/450 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450
Gastrointestinal disorders Diarrhoea	0.00% 0/455 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450	0.22% 1/450 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450
Gastrointestinal disorders Pancreatitis acute	0.22% 1/455 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450	0.00% 0/450 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450
Infections and infestations Orchitis	0.00% 0/455 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450	0.22% 1/450 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450
Infections and infestations Pneumonia	0.00% 0/455 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450	0.22% 1/450 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450
Infections and infestations Psoas abscess	0.00% 0/455 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450	0.22% 1/450 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450
Psychiatric disorders Suicide attempt	0.22% 1/455 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450	0.00% 0/450 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450
Renal and urinary disorders Renal colic	0.22% 1/455 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450	0.00% 0/450 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450
Renal and urinary disorders Urinary retention	0.00% 0/455 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450	0.22% 1/450 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.22% 1/455 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450	0.00% 0/450 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.22% 1/455 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450	0.00% 0/450 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450
Vascular disorders Deep vein thrombosis	0.22% 1/455 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450	0.00% 0/450 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450

Other adverse events

Other adverse events
Measure	Eravacycline n=455 participants at risk Eravacycline was administered IV at a dose of 1.5 mg/kg of body weight q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 200 mg PO BID for a total therapy of 7 dosing cycles.	Levofloxacin n=450 participants at risk Levofloxacin (750 mg) was administered IV q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 750 mg PO QD for a total therapy of 7 dosing cycles.
Gastrointestinal disorders Nausea	18.0% 82/455 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450	3.1% 14/450 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450
Gastrointestinal disorders Vomiting	7.3% 33/455 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450	1.3% 6/450 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450
Nervous system disorders Headache	3.1% 14/455 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450	1.3% 6/450 • The time frame for adverse event reporting was from the first dose of study drug through 30 days after the last dose of study drug or the late post-treatment visit (whichever was later). The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject was randomized to levofloxacin but received eravacycline, therefore Eravacycline N = 455; Levofloxacin N= 450

Additional Information

Chief Development Officer

La Jolla Pharmaceutical Company

Phone: 617-715-3600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publications should include input from the PI, his/her colleagues, other PIs in this trial and the Sponsor's personnel; such input should be reflected in the authorship. Agreement of order of authors should be established before writing a manuscript. The PI interested in participating in writing the manuscript should contact the Sponsor. The PI shall not make any publication without the Sponsor's prior written approval, which may be withheld or granted by the Sponsor, in its sole discretion.
Publication restrictions are in place

Restriction type: OTHER