Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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4 August 2015 |
Main ID: |
EUCTR2013-004556-38-PL |
Date of registration:
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19/02/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections
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Scientific title:
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A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared with Levofloxacin in Complicated Urinary Tract Infections - IGNITE2 |
Date of first enrolment:
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24/04/2014 |
Target sample size:
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840 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004556-38 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Double-dummy
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 3
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Phase:
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Countries of recruitment
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Argentina
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Bulgaria
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Chile
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Colombia
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Czech Republic
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Estonia
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Georgia
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Germany
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Greece
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Hungary
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India
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Israel
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Italy
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Korea, Republic of
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Latvia
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Mexico
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Moldova, Republic of
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Peru
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Poland
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Romania
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Russian Federation
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Singapore
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South Africa
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Taiwan
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Ukraine
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United States
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Contacts
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Name:
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Clinical Operation Department
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Address:
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ul. 1-go Sierpnia 6A
02-134
Warsaw
Poland |
Telephone:
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+4822210 02 00 |
Email:
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Affiliation:
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PSI Pharma Support Poland Sp. z o.o. |
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Name:
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Clinical Operation Department
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Address:
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ul. 1-go Sierpnia 6A
02-134
Warsaw
Poland |
Telephone:
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+4822210 02 00 |
Email:
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Affiliation:
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PSI Pharma Support Poland Sp. z o.o. |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Male and female subjects with either:
a. Pyelonephritis and normal urinary tract anatomy (approximately 50% of the total population), OR
b. cUTI with at least one of the following conditions associated with a risk for developing cUTI:
i. Indwelling urinary catheter
ii. Urinary retention (at least approximately 100 mL of residual urine after voiding)
iii. History of neurogenic bladder
iv. Partial obstructive uropathy (eg, nephrolithiasis, bladder stones, and ureteral strictures)
v. Azotemia of renal origin (not congestive heart failure [CHF] or volume related) such that the serum blood urea nitrogen [BUN] is elevated (> 20 mg/dL) AND the serum BUN:creatinine ratio is < 15
vi. Surgically modified or abnormal urinary tract anatomy (eg, bladder diverticula, redundant urine collection system, etc.) EXCEPT urinary tract surgery within the last month (placing of stents or catheters is not considered to be surgical modification)
2. At least 18 years of age
3. Able to provide informed consent
4. At least two of the following signs or symptoms:
a. Chills, rigors, or warmth associated with fever (oral, rectal, tympanic, or by temporal artery temperature > 100.4°F / 38°C) or hypothermia (oral, rectal, tympanic, or by temporal artery temperature < 95°F / 35°C)
b. Flank pain (pyelonephritis) or pelvic pain (cUTI)
c. Nausea or vomiting
d. Dysuria, urinary frequency, or urinary urgency
e. Costo-vertebral angle tenderness on physical examination
5. Urine specimen with evidence of pyuria
a. Dipstick analysis positive for leukocyte esterase (where positive result is at least “++” as indicated on the urine dipstick provided in the laboratory kit), OR
b. At least 10 white blood cells (WBCs) per cubic millimeter, OR
c. = 10 WBCs per high power field
6. The following subjects who have received previous/ongoing antibiotics will be eligible for enrollment:
a. Subjects with cUTI and a known baseline pathogen who have received prior antibiotic therapy for a minimum of 72 hours, but who are deemed clinical and microbiological failures (urine culture obtained after 72 hours of therapy with > 10,000 colony-forming units [CFU]/mL)
b. Subjects with suspected acute cUTI who have received a single dose of effective non-study antibiotics for the acute cUTI in the previous 24 hours
7. Subjects must agree to use a highly reliable method of birth control
a. Male subjects must agree to use an effective barrier method of contraception during the study and for 30 days following the last dose if sexually active with a female of childbearing potential
b. Female subjects must not be pregnant or nursing. For females of childbearing potential, subjects must commit to either:
i. Use at least two medically accepted, effective methods of birth control (eg, condom, spermicidal gel, oral contraceptive, indwelling intrauterine device, hormonal implant /patch, injections, approved cervical ring, etc.) during study drug dosing and for 30 days following last study drug dose, OR
ii. Sexual abstinence Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 756 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 84
Exclusion criteria: 1. Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in subjects with cUTI, including:
a. Subjects with a history of a levofloxacin-resistant urinary tract infection
b. Likely to receive ongoing antibacterial drug prophylaxis prior to the LPT visit (eg, subjects with vesiculo-ureteral reflux)
c. Use of systemic antibiotics effective in cUTI within 72 hours prior to enrollment except under circumstances meeting Inclusion Criterion 6
2. Likelihood that the subject will not survive at least through the duration of the study (approximately 4 weeks)
3. Hypotension, systolic blood pressure = 90 mmHg
4. 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 cathertors or obtain diagnosis)
5. Known or suspected urinary fungal infection
6. Uncomplicated lower urinary tract infections
7. Suspected or confirmed active prostatitis, or currently under treatment for prostatitis
8. Subjects with high risk for cUTI due to Pseudomonas sp. (eg, history of prior cUTIs due to Pseudomonas, = 20 mg QD prednisone or equivalent steroid, and other risk factors as perceived by the investigator)
9. History of renal transplantation
10. Presence of an ileal loop
11. Any history of trauma to the pelvis or urinary tract occurring within 30 days of screening
12. Indwelling urinary catheters present at screening expected to remain in place after IV therapy has been completed (eg, nephrostomy tubes, stents, urethral and suprapubic catheters)
13. Known concomitant HIV infection with CD4 counts below 200 cells/µL within the last six months, or an AIDS defining diagnosis within the last six months
14. Neutropenia (ANC < 1,000 PMNs/µL)
15. Creatinine clearance of < 50 mL/min as estimated by the Cockcroft-Gault equation (eCCr) (1):
eCCr [mL/min]=((140-Age [yrs] ) × Body Weight [kg] × [0.85 if Female])/(72 × Serum Creatinine [mg/dL])
Note: The following exclusion criterion may be substituted for that based on Cockcroft-Gault to determine eligibility: glomerular filtration rate < 50 mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease equation (eGFR) (2)
16. Removed in Global Protocol Version 3.0
17. Participation in a study with an experimental drug within 30 days
18. Known or suspected hypersensitivity to tetracyclines or fluoroquinolones
19. Any other unstable or clinically significant concurrent medical condition (ie, immunosuppressive therapy, chemotherapy, or class IV heart or lung disease) that would, in the opinion of the investigator, jeopardize the safety of a subject and/or their compliance with the protocol
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Complicated urinary tract Infections MedDRA version: 18.0
Level: LLT
Classification code 10046576
Term: Urinary tract infection, site not specified
System Organ Class: 100000004862
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Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
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Intervention(s)
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Product Name: eravacycline Product Code: TP-434 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: ERAVACYCLINE CAS Number: 1207283-85-9 Current Sponsor code: TP-434 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 53-
Product Name: eravacycline Product Code: TP-434 Pharmaceutical Form: Capsule INN or Proposed INN: ERAVACYCLINE CAS Number: 1207283-85-9 Current Sponsor code: TP-434 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use
Product Name: eravacycline Product Code: TP-434 Pharmaceutical Form: Capsule INN or Proposed INN: ERAVACYCLINE CAS Number: 1207283-85-9 Current Sponsor code: TP-434 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use
Product Name: Levofloxacin Pharmaceutical Form: Solution for infusion INN or Proposed INN: LEVOFLOXACIN CAS Number: 100986-85-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5-
Product Name: Levofloxacin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: LEVOFLOXACIN CAS Number: 100986-85-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: To compare clinical response for sbj in the treatment arms at Dose Cycle 3, End of IV Therapy (EOI), End of Therapy (EOT), PT, and Late Post-Treatment (LPT) visits in the following populations: Intent-to-Treat (ITT) population; Clinically evaluable (CE) population; Micro-ITT; Micro-MITT; Microbiologically evaluable (ME) population To compare time to resolution of signs and symptoms by treatment group. To compare microbiologic response in the treatment arms at Dose Cycle 3, EOI, EOT, PT, and LPT visits in the following populations: - Micro-ITT population - Micro-MITT population - ME population To assess safety and tolerability of erav administration in the safety population. To test for superiority of erav over levo in the treatment of cUTI: For the subset of subjects with infections caused by quinolone-resistant pathogens, eravacycline will be compared with levo in responder outcome in the micro-ITT population at the PT visit. To explore PK parameters of eravacycline
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Main Objective: To demonstrate that eravacycline is non-inferior to levofloxacin in responder outcome (clinical and microbiological response vs failure) in the micro-ITT population at the Post-Treatment (PT) visit (defined as 6-8 days after the completion of therapy).
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Primary end point(s): To demonstrate that eravacycline is non-inferior to levofloxacin in responder outcome (clinical and microbiological response vs failure) in the micro-MITT population at the Post-Treatment (PT) visit (defined as 6-8 days after the completion of therapy).
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Timepoint(s) of evaluation of this end point: the Post-Treatment (PT) visit
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Dose Cycle 3, EOI, EOT, PT, and LPT visits
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Secondary end point(s): 1.To compare clinical response for subjects in the treatment arms at Dose Cycle 3, End of IV Therapy (EOI), End of Therapy (EOT), PT, and Late Post-Treatment (LPT) visits in the following populations:
- Intent-to-Treat (ITT) population
- Clinically evaluable (CE) population
- Micro-ITT population
- Micro-MITT population
- Microbiologically evaluable (ME) population
2. To compare time to resolution of signs and symptoms by treatment group.
3. To compare microbiologic response in the treatment arms at Dose Cycle 3, EOI, EOT, PT and LPT visits in the following populations:
- Micro-ITT population
- Micro-MITT population
- ME population
4. To assess safety and tolerability of eravacycline administration in the safety population.
5. To test for superiority of eravacycline over levofloxacin in the treatment of cUTI:
- For the subset of subjects with infections caused by quinolone-resistant pathogens, eravacycline will be compared with levofloxacin in responder outcome in the micro-ITT population at the PT visit.
6. To explore pharmacokinetic (PK) parameters of eravacycline.
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Secondary ID(s)
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NCT01978938
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TP-434-010
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2013-004556-38-HU
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Source(s) of Monetary Support
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Tetraphase Pharmaceuticals, Inc.
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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