cUTI Clinical Trial
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
| Verified date | December 2021 |
| Source | La Jolla Pharmaceutical Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 908 |
| Est. completion date | August 21, 2015 |
| Est. primary completion date | June 3, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Nephrology | Gabrovo | |
| Bulgaria | Multiprofile Hospital for Active Treatment "Dr. Stamen Iliev", Montana, Department of Nephrology and Dialysis | Montana | |
| Bulgaria | University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic | Pleven | |
| Bulgaria | Multiprofile Hospital for Active Treatment, Ruse, Department of Urology | Rousse | |
| Bulgaria | Multiprofile Hospital for Active Treatment, Sofia at Military Medical Academy, General Urology Clinic | Sofia | |
| Bulgaria | University Multiprofile Hospital for Active Treatment "Aleksandrovska", Sofia, Department of Laparoscopic Urology | Sofia | |
| Bulgaria | University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic | Sofia | |
| Bulgaria | Multiprofile Regional Hospital for Active Treatment "Dr. Stefan Cherkezov", Veliko Tarnovo, Department of Urology | Veliko Tarnovo | |
| Colombia | Fundacion Cardiomet | Armenia | |
| Colombia | De la Costa Clinic. Ltd. Research Centre | Barranquilla | |
| Czechia | University Hospital Brno, Clinic of Urology | Brno | |
| Czechia | University Hospital Hradec Kralove, Clinic of Urology | Hradec Kralove | |
| Czechia | Hospital Novy Jicin, Department of Urology | Novy Jicin | |
| Czechia | University Hospital Olomouc | Olomouc | |
| Czechia | Thomayer Hospital, Department of Urology | Prague | |
| Estonia | East Viru Central Hospital, Surgery Clinic | Kohtla-Jarve | |
| Estonia | East Tallinn Central Hospital, Department of Internal Medicine | Tallinn | |
| Estonia | West Tallinn Central Hospital, Department of Urology | Tallinn | |
| Estonia | Tartu University Hospital, Surgery Clinic, Department of Urology and Renal Transplantation | Tartu | |
| Georgia | Western Georgia National Medical Center | Kutaisi | |
| Georgia | Aversi Clinic | Tbilisi | |
| Georgia | Modern Medical Technologies - Guram Karazanashvili's clinic | Tbilisi | |
| Georgia | Research Institute of Clinical Medicine | Tbilisi | |
| Georgia | Tsulukidze National Center of Urology | Tbilisi | |
| Greece | Evaggelismos Hospital | Kolonaki | |
| Greece | Papageorgiou General Hospital | Thessaloníki | |
| Hungary | Principal SMO Kft. | Baja | |
| Hungary | Jahn Ferenc South Pest Hospital, Department of Urology | Budapest | |
| Hungary | Petz Aladar County Teaching Hospital, Department of Urology | Gyor | |
| Hungary | Elisabeth Teaching Hospital and Rehabilitation Institute of Sopron, Department of Urology | Sopron | |
| Hungary | Csongrad County Dr. Bugyi Istvan Hospital, Department of Urology | Szentes | |
| Hungary | St. Borbala Hospital, Department of Urology | Tatabanya | |
| Israel | Zion Medical Center | Haifa | |
| Italy | Hospital Mater Domini | Castellanza | |
| Latvia | Liepajas Regional Hospital | Liepaja | |
| Latvia | P. Stradins Clinical University Hospital | Riga | |
| Latvia | Riga East University Hospital, LLC | Riga | |
| Latvia | SIA 'URO' Clinic | Riga | |
| Latvia | Vidzemes Hospital | Valmiera | |
| Mexico | Hospital Civil Fray Antonio Alcalde | Guadalajara | |
| Mexico | Hospital Civil Guadalajara Dr. Juan I. Mendoza | Guadalajara | |
| Moldova, Republic of | National Scientific Practical Center for Emergency Medicine, Department of Urology | Chisinau | |
| Moldova, Republic of | Republican Clinical Hospital, Department of Urology | Chisinau | |
| Poland | Boni Fratres Catoviensis Sp. z o.o., Department of Internal Diseases with Cardiologic Diagnostics Unit | Katowice | |
| Poland | 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 | Lodz | |
| Poland | Medicome Sp. z o.o. | Oswiecim | |
| Poland | HEUREKA Hanna Szalecka | Piaseczno | |
| Poland | Pope John Paul 2nd Independent Public Provincial Hospital | Zamosc | |
| Romania | Emergency Clinical County Hospital Brasov | Brasov | |
| Romania | "Prof. Dr. Th. Burghele" Clinical Hospital | Bucharest | |
| Romania | Delta Hospital | Bucharest | |
| Romania | Craiova Emergency Clinical County Hospital | Craiova | |
| Romania | Clinical Hospital "Dr. C. I. Parhon" | Ia?i | |
| Romania | Oradea Clinical Municipal Hospital "Dr. Gavril Curteanu" | Oradea | |
| Romania | Sibiu County Emergency Clinical Hospital | Sibiu | |
| Russian Federation | Central Clinical Hospital of Civil Aviation | Moscow | |
| Russian Federation | City Clinical Hospital #57 under Moscow Healthcare Department | Moscow | |
| Russian Federation | Federal Clinical Center for High Medical Technologies | Moscow | |
| Russian Federation | City Clinical Hospital of Emergency Care #2 | Novosibirsk | |
| Russian Federation | Penza Regional Clinical Hospital n.a. N.N. Burdenko | Penza | |
| Russian Federation | Rostov State Medical University | Rostov-on-Don | |
| Russian Federation | North-Western State Medical University n.a. I.I. Mechnikov | Saint Petersburg | |
| Russian Federation | Saint-Petersburg Scientific Research Institute for Phthisiopulmonology | Saint Petersburg | |
| Russian Federation | St. Petersburg Clinical Hospital under the Russian Academy of Sciences | Saint Petersburg | |
| Russian Federation | St. Petersburg State Healthcare Institution: City Hospital #15 | Saint Petersburg | |
| Russian Federation | St. Petersburg State Healthcare Institution: St. George the Martyr City Hospital | Saint Petersburg | |
| Russian Federation | St. Petersburg State-Funded Healthcare Institution: City Hospital #26 | Saint Petersburg | |
| Russian Federation | Saratov State Medical University n.a. V.I. Razumovsky | Saratov | |
| Russian Federation | Smolensk Regional Clinical Hospital | Smolensk | |
| Russian Federation | Novgorod Regional Clinical Hospital | Veliky Novgorod | |
| Russian Federation | Vsevolozhsk Clinical Central District Hospital | Vsevolozhsk | |
| South Africa | Lakeview Hospital | Benoni | |
| South Africa | Clinresco Centres | Kempton Park | |
| South Africa | Mzansi Ethical Research Centre | Middleburg | |
| South Africa | St. Georges Hospital | Port Elizabeth | |
| Ukraine | Regional Municipal Institution "Chernivtsi Regional Hospital" | Chernivtsi | |
| Ukraine | Dnipropetrovsk City Multispecialty Clinical Hospital #4 | Dnipropetrovsk | |
| Ukraine | Dnipropetrovsk I.I. Mechnikov Regional Clinical Hospital | Dnipropetrovsk | |
| Ukraine | Ivano-Frankivsk City Clinical Hospital #1 | Ivano-Frankivs'k | |
| Ukraine | Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivs'k | |
| Ukraine | O.I. Meschaninov Clinical Hospital of Emergency and Urgent Medical Care | Kharkiv | |
| Ukraine | Shapoval Regional Clinical Center of Urology and Nephrology | Kharkiv | |
| Ukraine | Khmelnytskyi Regional Hospital | Khmel'nyts'kyy | |
| Ukraine | Institute of Urology | Kyiv | |
| Ukraine | Lviv Regional Clinical Hospital | L'viv | |
| Ukraine | Volyn Regional Clinical Hospital | Luts'k | |
| Ukraine | Mykolaiv Regional Hospital, Center for Nephrology and Dialysis | Mykolaiv | |
| Ukraine | City Clinical Hospital #10, Urology Department #1 | Odesa | |
| Ukraine | Odesa Regional Clinical Hospital | Odessa | |
| Ukraine | Poltava M.V. Sklifosovskyi Regional Clinical Hospital | Poltava | |
| Ukraine | State Institution: Uzhhorod Railway Station Clinical Hospital under State Territorial Industry-Specific Association:Lviv Railway | Uzhhorod | |
| Ukraine | Vinnytsia M.I. Pyrohov Regional Clinical Hospital | Vinnytsya | |
| Ukraine | Municipal Institution "Zaporizhzhia Reqional Clinical Hospital" of Zaporizhzhia Regional Councill | Zaporizhzhya | |
| United States | Columbus Regional Research Institute | Columbus | Ohio |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | Sunrise Hospital and Medical Centre | Las Vegas | Nevada |
| United States | San Diego Clinical Trials | San Diego | California |
| United States | Tampa General Hospital | Tampa | Florida |
| United States | Harbor-UCLA Medical Center | Torrance | California |
| Lead Sponsor | Collaborator |
|---|---|
| Tetraphase Pharmaceuticals, Inc. |
United States, Bulgaria, Colombia, Czechia, Estonia, Georgia, Greece, Hungary, Israel, Italy, Latvia, Mexico, Moldova, Republic of, Poland, Romania, Russian Federation, South Africa, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Participants In The Microbiological Intent-To-Treat (Micro-ITT) Population With A Responder Outcome At The Post-Treatment (PT) Visit | This was the primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to levofloxacin 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. | PT Visit | |
| Secondary | Participants In The Microbiological Modified ITT (Micro-MITT) Population With A Microbiological Response | This outcome measure (FDA and the European Medicines Agency [EMA]) compared the microbiological responses of eravacycline to levofloxacin for both treatment groups in the micro-MITT population. Responses were success, failure, or indeterminate/missing. Success was considered a reduction of the baseline pathogen(s) to <10^4 CFU/mL. Failure required blood cultures at or beyond end of therapy (EOT) to be positive for baseline pathogen(s), or urine culture to grow =10^4 CFU/mL of the baseline pathogen(s). Indeterminate/missing indicated no interpretable culture data available. | PT Visit | |
| Secondary | Participants In The Microbiologically Evaluable (ME) Population With A Microbiological Response | This outcome measure (FDA and EMA) compared the microbiological responses of eravacycline to levofloxacin for both treatment groups in the ME population. Responses were either success or failure. Indeterminate/missing responses were not included. Success was considered a reduction of the baseline pathogen(s) to <10^4 CFU/mL. Failure required blood cultures at or beyond EOT to be positive for baseline pathogen(s), or urine culture to grow =10^4 CFU/mL of the baseline pathogen(s). Indeterminate/missing indicated no interpretable culture data available. Populations: ME, all micro-ITT and clinically-evaluable (CE) participants with a suitable urine specimen and an interpretable urine culture; micro-ITT, all participants with =1 baseline bacterial pathogen from a urine or blood culture that caused a UTI against which eravacycline had expected antibacterial activity; ITT, all randomized participants, regardless of receiving study drug or not. | PT Visit |