IGNITE3: Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Participants With Complicated Urinary Tract Infections

• Sponsor: Tetraphase Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03032510
• Collaborator: (none)
• Enrollment: 1,205
• Locations: 71
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site: 17
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of eravacycline compared to ertapenem in treating participants with complicated urinary tract infections (cUTI).

Condition or Disease	Intervention/Treatment	Phase
Complicated Urinary Tract Infections	Drug: Eravacycline; Drug: Ertapenem; Drug: Placebo; Drug: Levofloxacin	Phase 3

Detailed Description

The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of eravacycline compared to ertapenem in treating participants with complicated urinary tract infections (cUTI).

This is a phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety and pharmacokinetics of eravacycline compared with ertapenem in the treatment of cUTI.

Randomization will be stratified based on two criteria: (1) by primary site of infection (pyelonephritis and normal urinary tract anatomy vs all other diagnoses) and (2) by the receipt of a single dose of effective non-study antibiotics for the acute cUTI within 72 hours prior to randomization. An enrollment cap of approximately 50% is planned for subjects with pyelonephritis with normal urinary tract anatomy. Also, an enrollment cap of approximately 20% is planned for subjects who have received a single dose of non-study antibiotics for the acute cUTI within 72 hours prior to randomization.

In this study subjects will be enrolled and randomized to one of two treatment arms in a 1:1 ratio: (i) eravacycline intravenously (IV) / levofloxacin (PO), or (ii) ertapenem (IV) / levofloxacin (PO).

Study Design

• Study Type: Interventional
• Actual Enrollment: 1205 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of IV Eravacycline Compared With Ertapenem in Complicated Urinary Tract Infections
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eravacycline (Intravenous)/Levofloxacin (Oral)	Drug: Eravacycline; Other Names: TP-434 ; Drug: Placebo; Drug: Levofloxacin; Other Names: Levaquin
Active Comparator: Ertapenem (Intravenous)/Levofloxacin (Oral)	Drug: Ertapenem; Other Names: Invanz ; Drug: Placebo; Drug: Levofloxacin; Other Names: Levaquin

Outcome Measures

Primary Outcome Measures

1. Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the EOI Visit [End of Infusion]

   This was the co-primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to ertapenem 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.

2. Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the Test-Of-Cure (TOC) Visit [TOC visit (14-17 days after randomization)]

   This was the co-primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to ertapenem 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.

Secondary Outcome Measures

1. Proportion of Participants in the ITT Population With Favorable Clinical Outcomes at TOC Visit [TOC visit (14-17 days after randomization)]

   Clinical cure: A complete resolution or significant improvement of signs or symptoms of the infection such that no rescue/non-study antibacterial medication was required to treat the cUTI that presented at study entry. Clinical failure: Subjects were classified as clinical failure in the event of Death related to cUTI at any timepoint Persistence of clinical symptoms of cUTI or new symptoms developed Initiation of rescue/non-study antibacterial medication for cUTI Indeterminate: Study data were listed as indeterminate if the outcome was other than clinical cure or clinical failure. The reason for an indeterminate designation had to be provided Missing: Study data were listed as missing if the Investigator did not complete an assessment or if the subject did not complete the study visit.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Male or female participant with either:

2. Pyelonephritis and normal urinary tract anatomy (approximately 50% of the total population), or

3. cUTI with at least one of the following conditions associated with a risk for developing cUTI:

• Indwelling urinary catheter

• Urinary retention (at least approximately 100 milliliters (mL) of residual urine after voiding)

• History of neurogenic bladder

• Partial obstructive uropathy (for example, nephrolithiasis, bladder stones, and ureteral strictures)

• Azotemia of renal origin (not congestive heart failure [CHF] or volume related) such that the serum blood urea nitrogen [BUN] is elevated (>20 milligrams [mg]/deciliters [dL]) and the serum BUN:creatinine ratio is <15

• Surgically modified or abnormal urinary tract anatomy (for example, bladder diverticula, redundant urine collection system) except urinary tract surgery within the last 30 days (placing of stents or catheters is not considered to be surgical modification)

1. At least 18 years of age at time of consent

2. Able to provide informed consent

3. At least two of the following signs or symptoms:

4. Chills, rigors, or warmth associated with fever or hypothermia

5. Flank pain (pyelonephritis) or pelvic pain (cUTI)

6. Nausea or vomiting

7. Dysuria, urinary frequency, or urinary urgency

8. Costo-vertebral angle tenderness on physical examination

9. Urine specimen with evidence of pyuria

10. Dipstick analysis positive for leukocyte esterase (where positive result is at least "++" as indicated on the urine dipstick provided in the laboratory kit), or

11. ≥10 white blood cells (WBCs) per cubic millimeter, or

12. ≥10 WBCs per high power field

13. If male: must agree to use an effective barrier method of contraception (for example, condom) during the study and for 14 days following the last dose if sexually active with a female of childbearing potential

14. If female, not pregnant or nursing or, if of childbearing potential: must commit to either use at least two medically accepted, effective methods of birth control (for example, condom, spermicidal gel, oral contraceptive, indwelling intrauterine device, hormonal implant /patch, injections, approved cervical ring) during study drug dosing and for 14 days following last study drug dose or practicing sexual abstinence

Exclusion Criteria:

1. Use of systemic antibiotics effective in cUTI within 72 hours prior to enrollment except under the following circumstances:

2. Participants with suspected acute cUTI who have received a single dose of effective non-study antibiotics for the acute cUTI

3. Signs and symptoms of cUTI developed while on the antibiotic for another indication

4. History of an ertapenem-resistant urinary tract infection within 1 year of enrollment

5. Likely to require >10 days of antibiotic treatment to cure the acute cUTI or likely to receive ongoing antibacterial drug prophylaxis prior to the Follow Up visit (21-28 days after randomization) [for example, participants with chronic vesiculo-ureteral reflux]

6. Unlikely to survive at least through the duration of the study

7. Hypotension, systolic blood pressure ≤90 millimeters of mercury [mmHg]

8. Complicated pyelonephritis with complete obstruction or known or suspected renal or perinephric abscess, emphysematous pyelonephritis, or Any condition likely to require surgery to achieve cure (this does not include procedure to place catheters or obtain diagnosis)

9. Known or suspected urinary fungal infection

10. Uncomplicated lower urinary tract infections

11. Suspected or confirmed active prostatitis, or currently under treatment for prostatitis

12. High risk for cUTI due to Pseudomonas (for example, history of prior cUTIs due to Pseudomonas, ≥20 mg once a day prednisone or equivalent steroid, and other risk factors as perceived by the Investigator)

13. History of renal transplantation

14. Presence of an ileal loop

15. Any history of trauma to the pelvis or urinary tract occurring within 30 days of screening

16. Indwelling urinary catheters present at screening which are not expected to be removed or replaced within 72 hours of enrollment (for example, nephrostomy tubes, stents, urethral and suprapubic catheters).

17. Known concomitant human immunodeficiency virus (HIV) infection with CD4 counts below 200 within the last six months, or an acquired immune deficiency syndrome (AIDS) defining diagnosis within the last six months

18. Neutropenia (Absolute neutrophil count <1,000 polymorphonuclear leukocytes [PMNs]/microliters [µL])

19. Participation in a study with an experimental drug or device within 30 days prior to enrollment

20. Known or suspected hypersensitivity to tetracyclines, carbapenems, or β-lactams

21. History of seizures

22. Any other unstable or clinically significant concurrent medical condition (for example, immunosuppressive therapy, chemotherapy, class IV heart or lung disease, end stage renal disease, or requiring hemodialysis) that would, in the opinion of the Investigator, jeopardize the safety of a participant and/or their compliance with the protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Fullerton	California	United States
2		Los Angeles	California	United States
3		Torrance	California	United States
4		Coral Gables	Florida	United States
5		Doral	Florida	United States
6		Miami	Florida	United States
7		Columbus	Georgia	United States	31820
8		Saint Louis	Missouri	United States
9		Las Vegas	Nevada	United States
10		Baytown	Texas	United States
11		Graz		Austria
12		Linz		Austria
13		Salzburg		Austria
14		Pleven		Bulgaria
15		Plovdiv		Bulgaria
16		Razgrad		Bulgaria
17		Ruse		Bulgaria
18		Smyadovo		Bulgaria
19		Sofia		Bulgaria
20		Varna		Bulgaria
21		Veliko Tarnovo		Bulgaria
22		Tallinn		Estonia
23		Tartu		Estonia
24		Voru		Estonia
25		K'ut'aisi		Georgia
26		T'bilisi		Georgia
27		Baja		Hungary
28		Budapest		Hungary
29		Miskolc		Hungary
30		Nagykanizsa		Hungary
31		Nyiregyhaza		Hungary
32		Sopron		Hungary
33		Szentes		Hungary
34		Tatabanya		Hungary
35		Jelgava		Latvia
36		Riga		Latvia
37		Valmiera		Latvia
38		Chisinau		Moldova, Republic of
39		Braşov		Romania
40		Bucharest		Romania
41		Craiova		Romania
42		Oradea		Romania
43		Arkhangel'sk		Russian Federation
44		Moscow		Russian Federation
45		Pyatigorsk		Russian Federation
46		Rostov-on-the-Don		Russian Federation
47		Saint Petersburg		Russian Federation
48		Smolensk		Russian Federation
49		Vsevolozhsk		Russian Federation
50		Yaroslavl'		Russian Federation
51		Nitra		Slovakia
52		Poprad		Slovakia
53		Presov		Slovakia
54		Svidnik		Slovakia
55		Zilina		Slovakia
56		Chernihiv		Ukraine
57		Chernivtsi		Ukraine
58		Dnipro		Ukraine
59		Ivano-Frankivsk		Ukraine
60		Kharkiv		Ukraine
61		Kyiv		Ukraine
62		L'viv		Ukraine
63		Lviv		Ukraine
64		Mykolaiv		Ukraine
65		Odesa		Ukraine
66		Poltava		Ukraine
67		Uzhgorod		Ukraine
68		Uzhorod		Ukraine
69		Vinnytsya		Ukraine
70		Zaporizhia		Ukraine
71		Zhytomyr		Ukraine

Sponsors and Collaborators

• Tetraphase Pharmaceuticals, Inc.

Investigators

• Study Director: Chief Medical Officer, Tetraphase Pharmaceuticals

Study Documents (Full-Text)

• Study Protocol - Jul 27, 2016
• Statistical Analysis Plan - Jan 22, 2018

More Information

Publications

None provided.

• Responsible Party: Tetraphase Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT03032510
• Other Study ID Numbers: TP-434-021
• First Posted: Jan 26, 2017
• Last Update Posted: Jan 6, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Levofloxacin; Ofloxacin; Ertapenem

Study Results

Participant Flow

Arm/Group Title	Eravacycline (Intravenous)/Levofloxacin (Oral)	Ertapenem (Intravenous)/Levofloxacin (Oral)
Arm/Group Description	Eravacycline 1.5mg/kg IV q24h Placebo IV q24h Levofloxacin (PO)	Ertapenem 1g IV q24h Placebo IV q24h Levofloxacin (PO)
Period Title: Overall Study
STARTED	603	602
COMPLETED	576	584
NOT COMPLETED	27	18

Baseline Characteristics

Arm/Group Title	Eravacycline (Intravenous)/Levofloxacin (Oral)	Ertapenem (Intravenous)/Levofloxacin (Oral)	Total
Arm/Group Description	Eravacycline 1.5 mg/kg IV q24h Placebo IV Levofloxacin PO	Ertapenem 1.0g IV q24h Placebo IV Levofloxacin PO	Total of all reporting groups
Overall Participants	603	602	1205
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	338 56.1%	331 55%	669 55.5%
>=65 years	265 43.9%	271 45%	536 44.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.1 (18.16)	56.5 (19.34)	56.8 (18.7)
Sex: Female, Male (Count of Participants)
Female	330 54.7%	343 57%	673 55.9%
Male	273 45.3%	259 43%	532 44.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	11 1.8%	15 2.5%	26 2.2%
Not Hispanic or Latino	592 98.2%	587 97.5%	1179 97.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 0.2%	0 0%	1 0.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 0.3%	1 0.2%	3 0.2%
White	600 99.5%	601 99.8%	1201 99.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Latvia	36 6%	39 6.5%	75 6.2%
Austria	0 0%	1 0.2%	1 0.1%
Romania	54 9%	59 9.8%	113 9.4%
Hungary	56 9.3%	66 11%	122 10.1%
United States	9 1.5%	13 2.2%	22 1.8%
Ukraine	148 24.5%	137 22.8%	285 23.7%
Georgia	33 5.5%	40 6.6%	73 6.1%
Slovakia	18 3%	13 2.2%	31 2.6%
Bulgaria	61 10.1%	42 7%	103 8.5%
Estonia	21 3.5%	20 3.3%	41 3.4%
Russia	126 20.9%	143 23.8%	269 22.3%
Poland	23 3.8%	17 2.8%	40 3.3%
Moldova	18 3%	12 2%	30 2.5%

Outcome Measures

1. Primary Outcome

Title	Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the EOI Visit
Description	This was the co-primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to ertapenem 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.
Time Frame	End of Infusion

Outcome Measure Data

Analysis Population Description

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 and ertapenem had expected antibacterial activity.

Arm/Group Title	Eravacycline (Intravenous)	Ertapenem (Intravenous)
Arm/Group Description	Eravacycline was administered IV at a dose of 1.5 mg/kg of body weight q24h. At minimum, the first 5 doses were administered IV. An IV-to-PO transition could occur after dose 5. During PO administration, subjects received 750 mg of levofloxacin once daily. Total treatment duration was 7 or 10 days.	Ertapenem was administered IV at a dose of 1 g q24h. At minimum, the first 5 doses were administered IV. An IV-to-PO transition could occur after dose 5. During PO administration, subjects received 750 mg of levofloxacin once daily. Total treatment duration was 7 or 10 days.
Measure Participants	428	403
Responder	363 60.2%	382 63.5%
Non-responder	51 8.5%	7 1.2%
Indeterminate	14 2.3%	14 2.3%

2. Primary Outcome

Title	Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the Test-Of-Cure (TOC) Visit
Description	This was the co-primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to ertapenem 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.
Time Frame	TOC visit (14-17 days after randomization)

Outcome Measure Data

Analysis Population Description

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 and ertapenem had expected antibacterial activity.

Arm/Group Title	Eravacycline	Ertapenem
Arm/Group Description	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 and ertapenem had expected antibacterial activity.	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 and ertapenem had expected antibacterial activity.
Measure Participants	428	403
Responder	293 48.6%	302 50.2%
Non-responder	116 19.2%	86 14.3%
Indeterminate	19 3.2%	15 2.5%

3. Secondary Outcome

Title	Proportion of Participants in the ITT Population With Favorable Clinical Outcomes at TOC Visit
Description	Clinical cure: A complete resolution or significant improvement of signs or symptoms of the infection such that no rescue/non-study antibacterial medication was required to treat the cUTI that presented at study entry. Clinical failure: Subjects were classified as clinical failure in the event of Death related to cUTI at any timepoint Persistence of clinical symptoms of cUTI or new symptoms developed Initiation of rescue/non-study antibacterial medication for cUTI Indeterminate: Study data were listed as indeterminate if the outcome was other than clinical cure or clinical failure. The reason for an indeterminate designation had to be provided Missing: Study data were listed as missing if the Investigator did not complete an assessment or if the subject did not complete the study visit.
Time Frame	TOC visit (14-17 days after randomization)

Outcome Measure Data

Analysis Population Description

ITT included all randomized participants, regardless of receiving study drug or not.

Arm/Group Title	Eravacycline (Intravenous)/Levofloxacin (Oral)	Ertapenem (Intravenous)/Levofloxacin (Oral)
Arm/Group Description	ITT included all randomized participants, regardless of receiving study drug or not.	ITT included all randomized participants, regardless of receiving study drug or not.
Measure Participants	603	602
Clinical Cure	547 90.7%	566 94%
Clinical Failure	31 5.1%	20 3.3%
Indeterminate/missing	25 4.1%	16 2.7%

Adverse Events

Time Frame	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 FU visit (whichever was later).
Adverse Event Reporting Description	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 randomized to the ertapenem group received a dose of eravacycline and was included in the eravacycline group in the safety analysis.
Arm/Group Title	Eravacycline (Intravenous)		Ertapenem (Intravenous)
Arm/Group Description	Eravacycline 1.5 mg/kg IV -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 randomized to the ertapenem group received a dose of eravacycline and was included in the eravacycline group in the safety analysis.		Ertapenem 1 g IV-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 randomized to the ertapenem group received a dose of eravacycline and was included in the eravacycline group in the safety analysis.
All Cause Mortality
	Eravacycline (Intravenous)		Ertapenem (Intravenous)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/601 (0.5%)		2/600 (0.3%)
Serious Adverse Events
	Eravacycline (Intravenous)		Ertapenem (Intravenous)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/601 (1.8%)		6/600 (1%)
Cardiac disorders
Acute myocardial infarction	1/601 (0.2%)		0/600 (0%)
Cardiorenal syndrome	0/601 (0%)		1/600 (0.2%)
Myocardial infarction	1/601 (0.2%)		0/600 (0%)
Gastrointestinal disorders
Diarrhoea	1/601 (0.2%)		0/600 (0%)
Haemorrhoids	0/601 (0%)		1/600 (0.2%)
Ileus	1/601 (0.2%)		0/600 (0%)
Immune system disorders
Drug hypersensitivity	1/601 (0.2%)		0/600 (0%)
Infections and infestations
Clostridium difficile colitis	0/601 (0%)		1/600 (0.2%)
Pneumonia	1/601 (0.2%)		0/600 (0%)
Renal abscess	0/601 (0%)		1/600 (0.2%)
Urosepsis	1/601 (0.2%)		0/600 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma	0/601 (0%)		1/600 (0.2%)
Nervous system disorders
Cerebrovascular accident	2/601 (0.3%)		0/600 (0%)
Renal and urinary disorders
Renal colic	1/601 (0.2%)		0/600 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	1/601 (0.2%)		0/600 (0%)
Skin and subcutaneous tissue disorders
Decubitus ulcer	1/601 (0.2%)		0/600 (0%)
Vascular disorders
Aneurysm ruptured	2/601 (0.3%)		1/600 (0.2%)
Circulatory collapse	0/601 (0%)		1/600 (0.2%)
Deep vein thrombosis	1/601 (0.2%)		0/600 (0%)
Other (Not Including Serious) Adverse Events
	Eravacycline (Intravenous)		Ertapenem (Intravenous)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	174/601 (29%)		52/600 (8.7%)
Gastrointestinal disorders
Nausea	84/601 (14%)		10/600 (1.7%)
Vomiting	31/601 (5.2%)		4/600 (0.7%)
Diarrhoea	18/601 (3%)		17/600 (2.8%)
General disorders
Infusion site phlebitis	24/601 (4%)		3/600 (0.5%)
Headache	17/601 (2.8%)		18/600 (3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.