A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)
NCT ID: NCT01096849
Last Updated: 2018-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
145 participants
INTERVENTIONAL
2010-07-13
2012-04-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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plazomicin (10 mg/kg)
Patients received two intravenous (IV) infusions daily for 5 consecutive days: 10 milligrams per kilogram (mg/kg) plazomicin followed by placebo.
plazomicin
placebo
plazomicin (15 mg/kg)
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
plazomicin
placebo
levofloxacin
Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 milligrams (mg) levofloxacin.
levofloxacin
placebo
Interventions
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levofloxacin
plazomicin
placebo
Eligibility Criteria
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Inclusion Criteria
* Normal kidney function defined as creatinine clearance (CLcr) of ≥60mL/min using Cockcroft-Gault formula
Exclusion Criteria
* Gross heanaturia requiring intervention other than study drug
* Urinary tract surgery within 7 days of randomization or during the study period
* A known nonrenal source of infection diagnosed within 7 days of randomization
* A corrected QT interval \> 440 msec
* History of hearing loss with onset before the age of 40 years, sensorineural hearing loss, or family history of hearing loss
* Pregnant or breastfeeding women
18 Years
85 Years
ALL
No
Sponsors
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Achaogen, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Achaogen, Inc.
References
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Connolly LE, Riddle V, Cebrik D, Armstrong ES, Miller LG. A Multicenter, Randomized, Double-Blind, Phase 2 Study of the Efficacy and Safety of Plazomicin Compared with Levofloxacin in the Treatment of Complicated Urinary Tract Infection and Acute Pyelonephritis. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e01989-17. doi: 10.1128/AAC.01989-17. Print 2018 Apr.
Other Identifiers
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ACHN-490-002
Identifier Type: -
Identifier Source: org_study_id
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