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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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02486627 |
Date of registration:
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25/06/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)
EPIC |
Scientific title:
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A Phase 3, Randomized, Multicenter, Double-Blind Study to Evaluate the Efficacy and Safety of Plazomicin Compared With Meropenem Followed by Optional Oral Therapy for the Treatment of Complicated Urinary Tract Infection (cUTI), Including Acute Pyelonephritis (AP), in Adults |
Date of first enrolment:
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January 11, 2016 |
Target sample size:
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609 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02486627 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Bulgaria
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Estonia
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Georgia
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Hungary
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Latvia
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Poland
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Romania
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Russian Federation
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Serbia
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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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Lynn E Connolly, MD, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Achaogen, Inc. |
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- Pyuria
- Have a pretreatment baseline urine culture obtained within 36 hours before the start
of administration of the first dose of study drug
- Clinical signs and/or symptoms of acute pyelonephritis or complicated urinary tract
infection
- Normal renal function or moderate renal impairment
Key Exclusion Criteria:
- Confirmed fungal urinary tract infection at the time of randomization
- Known urinary tract infection or colonization with Gram-positive pathogens
- Current cUTI or AP is known to be caused by a pathogen resistant to meropenem
- Female participants of childbearing potential if they are known to be pregnant or have
a positive pregnancy test at screening, breastfeeding, or unable or unwilling to use a
highly effective method of birth control during the study and for at least 30 days
following the last dose of study medication
- Any rapidly progressing disease or immediately life-threatening illness
- Documented presence of immunodeficiency or an immunocompromised condition
- Documented or known history of otologic surgery or disease including use of hearing
aid, head injury leading to otologic damage, Ménière's disease, tumor of the head,
neck, or auditory system, perilymphatic fistula, or autoimmune disease of the inner
ear, or family history of hearing loss (excluding age-related hearing loss [onset
after age of 65 years])
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Complicated Urinary Tract Infection
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Acute Pyelonephritis
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Intervention(s)
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Drug: meropenem
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Drug: levofloxacin (oral)
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Drug: plazomicin
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Primary Outcome(s)
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Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the mMITT Population at Test of Cure (TOC)
[Time Frame: Day 17 TOC Visit]
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Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the Microbiological Modified ITT (mMITT) Population at Day 5
[Time Frame: Day 5]
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Secondary Outcome(s)
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Plasma PK: Maximum Observed Plasma Drug Concentration (Cmax)
[Time Frame: Day 3]
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Plasma Pharmacokinetics (PK): Area Under the Curve From 0 to 24 Hours (AUC 0-24h)
[Time Frame: Day 3]
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Percentage of Patients With Treatment-Emergent Adverse Events (TEAEs)
[Time Frame: Up to Day 32]
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Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the ME Population at TOC
[Time Frame: Day 17 TOC Visit]
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Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the ME Population at Day 5
[Time Frame: Day 5]
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Plasma PK: Minimum Observed Plasma Drug Concentration (Cmin)
[Time Frame: Day 3]
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Secondary ID(s)
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U1111-1171-1554
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2015-001588-37
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ACHN-490-009
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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