Clinical trial NCT01978938: Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: cUTI
Lead sponsor: La Jolla Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2013-11-08
Enrollment: 908
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy and safety of eravacycline compared with levofloxacin in participants with complicated urinary tract infections (cUTI).

Detailed description: This study began with a 3-arm Lead-in portion to determine the oral (PO) dosing (200 or 250 milligrams \[mg\]) of eravacycline to be used with intravenously (IV) administered eravacycline for the Pivotal portion (2 arms). A PO dose of 200 mg was selected based on the unblinded Lead-in analysis.

Eligibility criteria: Inclusion Criteria:

1. Male and female participants with either:

a. Pyelonephritis and normal urinary tract anatomy (approximately 50% of the total population), OR b. cUTI with at least 1 of the following conditions associated with a risk for developing cUTI: i. Indwelling urinary catheter ii. Urinary retention (approximately 100 milliliters of residual urine after voiding) iii. Neurogenic bladder iv. Partial obstructive uropathy (such as, nephrolithiasis, bladder stones, and ureteral strictures) v. Azotemia of renal origin (not congestive heart failure or volume related) such that the serum blood urea nitrogen (BUN) is elevated (\>20 mg/deciliters) AND the serum BUN: creatinine ratio is \<15 vi. Surgically modified or abnormal urinary tract anatomy (such as, bladder diverticula, redundant urine collection system) EXCEPT surgery within the last month

Exclusion Criteria:

1. Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in participants with cUTI, including:

1. Participants with a history of a levofloxacin-resistant urinary tract infection
2. Likely to receive ongoing antibacterial drug prophylaxis prior to the late Post-Treatment visit (such as, participants with vesiculo-ureteral reflux)

Primary outcomes:
measure: Participants In The Microbiological Intent-To-Treat (Micro-ITT) Population With A Responder Outcome At The Post-Treatment (PT) Visit
timeFrame: PT Visit
Secondary outcomes:
measure: Participants In The Microbiological Modified ITT (Micro-MITT) Population With A Microbiological Response
timeFrame: PT Visit
measure: Participants In The Microbiologically Evaluable (ME) Population With A Microbiological Response
timeFrame: PT Visit
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Clinical Trials
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Las Vegas
country: United States
facility: Sunrise Hospital and Medical Centre
state: Nevada
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Ohio
city: Gabrovo
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Nephrology
city: Montana
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment "Dr. Stamen Iliev", Montana, Department of Nephrology and Dialysis
city: Pleven
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic
city: Rousse
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment, Ruse, Department of Urology
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment, Sofia at Military Medical Academy, General Urology Clinic
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Aleksandrovska", Sofia, Department of Laparoscopic Urology
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic
city: Veliko Tarnovo
country: Bulgaria
facility: Multiprofile Regional Hospital for Active Treatment "Dr. Stefan Cherkezov", Veliko Tarnovo, Department of Urology
city: Armenia
country: Colombia
facility: Fundacion Cardiomet
city: Barranquilla
country: Colombia
facility: De la Costa Clinic. Ltd. Research Centre
city: Brno
country: Czechia
facility: University Hospital Brno, Clinic of Urology
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove, Clinic of Urology
city: Novy Jicin
country: Czechia
facility: Hospital Novy Jicin, Department of Urology
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Prague
country: Czechia
facility: Thomayer Hospital, Department of Urology
city: Kohtla-Jarve
country: Estonia
facility: East Viru Central Hospital, Surgery Clinic
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital, Department of Internal Medicine
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital, Department of Urology
city: Tartu
country: Estonia
facility: Tartu University Hospital, Surgery Clinic, Department of Urology and Renal Transplantation
city: Kutaisi
country: Georgia
facility: Western Georgia National Medical Center
city: Tbilisi
country: Georgia
facility: Aversi Clinic
city: Tbilisi
country: Georgia
facility: Modern Medical Technologies - Guram Karazanashvili's clinic
city: Tbilisi
country: Georgia
facility: Research Institute of Clinical Medicine
city: Tbilisi
country: Georgia
facility: Tsulukidze National Center of Urology
city: Kolonaki
country: Greece
facility: Evaggelismos Hospital
city: Thessaloníki
country: Greece
facility: Papageorgiou General Hospital
city: Baja
country: Hungary
facility: Principal SMO Kft.
city: Budapest
country: Hungary
facility: Jahn Ferenc South Pest Hospital, Department of Urology
city: Gyor
country: Hungary
facility: Petz Aladar County Teaching Hospital, Department of Urology
city: Sopron
country: Hungary
facility: Elisabeth Teaching Hospital and Rehabilitation Institute of Sopron, Department of Urology
city: Szentes
country: Hungary
facility: Csongrad County Dr. Bugyi Istvan Hospital, Department of Urology
city: Tatabanya
country: Hungary
facility: St. Borbala Hospital, Department of Urology
city: Haifa
country: Israel
facility: Zion Medical Center
city: Castellanza
country: Italy
facility: Hospital Mater Domini
city: Liepaja
country: Latvia
facility: Liepajas Regional Hospital
city: Riga
country: Latvia
facility: P. Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Riga East University Hospital, LLC
city: Riga
country: Latvia
facility: SIA 'URO' Clinic
city: Valmiera
country: Latvia
facility: Vidzemes Hospital
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde
city: Guadalajara
country: Mexico
facility: Hospital Civil Guadalajara Dr. Juan I. Mendoza
city: Chisinau
country: Moldova, Republic of
facility: National Scientific Practical Center for Emergency Medicine, Department of Urology
city: Chisinau
country: Moldova, Republic of
facility: Republican Clinical Hospital, Department of Urology
city: Katowice
country: Poland
facility: Boni Fratres Catoviensis Sp. z o.o., Department of Internal Diseases with Cardiologic Diagnostics Unit
city: Lodz
country: Poland
facility: Military Medical Academy University Teaching Hospital - Central Veterans' Hospital, Clinical and Didactic Center of the Medical University of Lodz, Teaching Department of Nephrology, Hypertension and Renal Transplantation
city: Oswiecim
country: Poland
facility: Medicome Sp. z o.o.
city: Piaseczno
country: Poland
facility: HEUREKA Hanna Szalecka
city: Zamość
country: Poland
facility: Pope John Paul 2nd Independent Public Provincial Hospital
city: Brasov
country: Romania
facility: Emergency Clinical County Hospital Brasov
city: Bucharest
country: Romania
facility: "Prof. Dr. Th. Burghele" Clinical Hospital
city: Bucharest
country: Romania
facility: Delta Hospital
city: Craiova
country: Romania
facility: Craiova Emergency Clinical County Hospital
city: Iași
country: Romania
facility: Clinical Hospital "Dr. C. I. Parhon"
city: Oradea
country: Romania
facility: Oradea Clinical Municipal Hospital "Dr. Gavril Curteanu"
city: Sibiu
country: Romania
facility: Sibiu County Emergency Clinical Hospital
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of Civil Aviation
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #57 under Moscow Healthcare Department
city: Moscow
country: Russian Federation
facility: Federal Clinical Center for High Medical Technologies
city: Novosibirsk
country: Russian Federation
facility: City Clinical Hospital of Emergency Care #2
city: Penza
country: Russian Federation
facility: Penza Regional Clinical Hospital n.a. N.N. Burdenko
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
city: Saint Petersburg
country: Russian Federation
facility: North-Western State Medical University n.a. I.I. Mechnikov
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg Scientific Research Institute for Phthisiopulmonology
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg Clinical Hospital under the Russian Academy of Sciences
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Healthcare Institution: City Hospital #15
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Healthcare Institution: St. George the Martyr City Hospital
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State-Funded Healthcare Institution: City Hospital #26
city: Saratov
country: Russian Federation
facility: Saratov State Medical University n.a. V.I. Razumovsky
city: Smolensk
country: Russian Federation
facility: Smolensk Regional Clinical Hospital
city: Veliky Novgorod
country: Russian Federation
facility: Novgorod Regional Clinical Hospital
city: Vsevolozhsk
country: Russian Federation
facility: Vsevolozhsk Clinical Central District Hospital
city: Benoni
country: South Africa
facility: Lakeview Hospital
city: Kempton Park
country: South Africa
facility: Clinresco Centres
city: Middleburg
country: South Africa
facility: Mzansi Ethical Research Centre
city: Port Elizabeth
country: South Africa
facility: St. Georges Hospital
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Institution "Chernivtsi Regional Hospital"
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk City Multispecialty Clinical Hospital #4
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk I.I. Mechnikov Regional Clinical Hospital
city: Ivano-Frankivs'k
country: Ukraine
facility: Ivano-Frankivsk City Clinical Hospital #1
city: Ivano-Frankivs'k
country: Ukraine
facility: Ivano-Frankivsk Regional Clinical Hospital
city: Kharkiv
country: Ukraine
facility: O.I. Meschaninov Clinical Hospital of Emergency and Urgent Medical Care
city: Kharkiv
country: Ukraine
facility: Shapoval Regional Clinical Center of Urology and Nephrology
city: Khmel'nyts'kyy
country: Ukraine
facility: Khmelnytskyi Regional Hospital
city: Kyiv
country: Ukraine
facility: Institute of Urology
city: L'viv
country: Ukraine
facility: Lviv Regional Clinical Hospital
city: Luts'k
country: Ukraine
facility: Volyn Regional Clinical Hospital
city: Mykolaiv
country: Ukraine
facility: Mykolaiv Regional Hospital, Center for Nephrology and Dialysis
city: Odesa
country: Ukraine
facility: City Clinical Hospital #10, Urology Department #1
city: Odessa
country: Ukraine
facility: Odesa Regional Clinical Hospital
city: Poltava
country: Ukraine
facility: Poltava M.V. Sklifosovskyi Regional Clinical Hospital
city: Uzhhorod
country: Ukraine
facility: State Institution: Uzhhorod Railway Station Clinical Hospital under State Territorial Industry-Specific Association:Lviv Railway
city: Vinnytsya
country: Ukraine
facility: Vinnytsia M.I. Pyrohov Regional Clinical Hospital
city: Zaporizhzhya
country: Ukraine
facility: Municipal Institution "Zaporizhzhia Reqional Clinical Hospital" of Zaporizhzhia Regional Councill
Study officials:
References: