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cUTIPhase 3NCT01978938

Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections

A Phase 3 study testing Eravacycline and Levofloxacin in people with cUTI, run by Tetraphase Pharmaceuticals, Inc at 99 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
cUTI
What is being tested?
Eravacycline and Levofloxacin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
908 participants
Where
99 sitesin 18 countries
Study dates
6 Oct 2014to 21 Aug 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Male and female participants with either:
  • 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

Who cannot join

  • 1. Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in participants with cUTI, including:
  • Participants with a history of a levofloxacin-resistant urinary tract infection
  • Likely to receive ongoing antibacterial drug prophylaxis prior to the late Post-Treatment visit (such as, participants with vesiculo-ureteral reflux)

Trial locations and contacts

99 sites in 18 countries.

99 sites in 18 countries

Ukraine18 sites

  • Regional Municipal Institution "Chernivtsi Regional Hospital"

    Chernivtsi

  • Dnipropetrovsk City Multispecialty Clinical Hospital #4

    Dnipropetrovsk

  • Dnipropetrovsk I.I. Mechnikov Regional Clinical Hospital

    Dnipropetrovsk

  • Ivano-Frankivsk City Clinical Hospital #1

    Ivano-Frankivsk

  • Ivano-Frankivsk Regional Clinical Hospital

    Ivano-Frankivsk

  • O.I. Meschaninov Clinical Hospital of Emergency and Urgent Medical Care

    Kharkiv

  • Shapoval Regional Clinical Center of Urology and Nephrology

    Kharkiv

  • Khmelnytskyi Regional Hospital

    Khmelnytskyi

  • Institute of Urology

    Kyiv

  • Volyn Regional Clinical Hospital

    Lutsk

  • Lviv Regional Clinical Hospital

    Lviv

  • Mykolaiv Regional Hospital, Center for Nephrology and Dialysis

    Mykolaiv

  • City Clinical Hospital #10, Urology Department #1

    Odesa

  • Odesa Regional Clinical Hospital

    Odesa

  • Poltava M.V. Sklifosovskyi Regional Clinical Hospital

    Poltava

  • State Institution: Uzhhorod Railway Station Clinical Hospital under State Territorial Industry-Specific Association:Lviv Railway

    Uzhhorod

  • Vinnytsia M.I. Pyrohov Regional Clinical Hospital

    Vinnytsia

  • Municipal Institution "Zaporizhzhia Reqional Clinical Hospital" of Zaporizhzhia Regional Councill

    Zaporizhzhya

Other trials in Ukraine

Russia16 sites

  • Central Clinical Hospital of Civil Aviation

    Moscow

  • City Clinical Hospital #57 under Moscow Healthcare Department

    Moscow

  • Federal Clinical Center for High Medical Technologies

    Moscow

  • City Clinical Hospital of Emergency Care #2

    Novosibirsk

  • Penza Regional Clinical Hospital n.a. N.N. Burdenko

    Penza

  • Rostov State Medical University

    Rostov-on-Don

  • North-Western State Medical University n.a. I.I. Mechnikov

    Saint Petersburg

  • Saint-Petersburg Scientific Research Institute for Phthisiopulmonology

    Saint Petersburg

  • St. Petersburg Clinical Hospital under the Russian Academy of Sciences

    Saint Petersburg

  • St. Petersburg State Healthcare Institution: City Hospital #15

    Saint Petersburg

  • St. Petersburg State Healthcare Institution: St. George the Martyr City Hospital

    Saint Petersburg

  • St. Petersburg State-Funded Healthcare Institution: City Hospital #26

    Saint Petersburg

  • Saratov State Medical University n.a. V.I. Razumovsky

    Saratov

  • Smolensk Regional Clinical Hospital

    Smolensk

  • Novgorod Regional Clinical Hospital

    Velikiy Novgorod

  • Vsevolozhsk Clinical Central District Hospital

    Vsevolozhsk

Other trials in Russia

Bulgaria8 sites

  • Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Nephrology

    Gabrovo

  • Multiprofile Hospital for Active Treatment "Dr. Stamen Iliev", Montana, Department of Nephrology and Dialysis

    Montana

  • University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic

    Pleven

  • Multiprofile Hospital for Active Treatment, Ruse, Department of Urology

    Rousse

  • Multiprofile Hospital for Active Treatment, Sofia at Military Medical Academy, General Urology Clinic

    Sofia

  • University Multiprofile Hospital for Active Treatment "Aleksandrovska", Sofia, Department of Laparoscopic Urology

    Sofia

  • University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic

    Sofia

  • Multiprofile Regional Hospital for Active Treatment "Dr. Stefan Cherkezov", Veliko Tarnovo, Department of Urology

    Veliko Tarnovo

Other trials in Bulgaria

Romania7 sites

  • Emergency Clinical County Hospital Brasov

    Brasov

  • "Prof. Dr. Th. Burghele" Clinical Hospital

    Bucharest

  • Delta Hospital

    Bucharest

  • Craiova Emergency Clinical County Hospital

    Craiova

  • Clinical Hospital "Dr. C. I. Parhon"

    Iași

  • Oradea Clinical Municipal Hospital "Dr. Gavril Curteanu"

    Oradea

  • Sibiu County Emergency Clinical Hospital

    Sibiu

Other trials in Romania

United States6 sites

  • Columbus Regional Research Institute

    Columbus, Ohio

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Sunrise Hospital and Medical Centre

    Las Vegas, Nevada, 89109

  • San Diego Clinical Trials

    San Diego, California

  • Tampa General Hospital

    Tampa, Florida

  • Harbor-UCLA Medical Center

    Torrance, California

Other trials in United States

Hungary6 sites

  • Principal SMO Kft.

    Baja

  • Jahn Ferenc South Pest Hospital, Department of Urology

    Budapest

  • Petz Aladar County Teaching Hospital, Department of Urology

    Győr

  • Elisabeth Teaching Hospital and Rehabilitation Institute of Sopron, Department of Urology

    Sopron

  • Csongrad County Dr. Bugyi Istvan Hospital, Department of Urology

    Szentes

  • St. Borbala Hospital, Department of Urology

    Tatabánya

Other trials in Hungary

Czechia5 sites

  • University Hospital Brno, Clinic of Urology

    Brno

  • University Hospital Hradec Kralove, Clinic of Urology

    Hradec Králové

  • Hospital Novy Jicin, Department of Urology

    Nový Jičín

  • University Hospital Olomouc

    Olomouc

  • Thomayer Hospital, Department of Urology

    Prague

Other trials in Czechia

Georgia5 sites

  • Western Georgia National Medical Center

    Kutaisi

  • Aversi Clinic

    Tbilisi

  • Modern Medical Technologies - Guram Karazanashvili's clinic

    Tbilisi

  • Research Institute of Clinical Medicine

    Tbilisi

  • Tsulukidze National Center of Urology

    Tbilisi

Other trials in Georgia

Latvia5 sites

  • Liepajas Regional Hospital

    Liepāja

  • P. Stradins Clinical University Hospital

    Riga

  • Riga East University Hospital, LLC

    Riga

  • SIA 'URO' Clinic

    Riga

  • Vidzemes Hospital

    Valmiera

Other trials in Latvia

Poland5 sites

  • Boni Fratres Catoviensis Sp. z o.o., Department of Internal Diseases with Cardiologic Diagnostics Unit

    Katowice

  • 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

  • Medicome Sp. z o.o.

    Oświęcim

  • HEUREKA Hanna Szalecka

    Piaseczno

  • Pope John Paul 2nd Independent Public Provincial Hospital

    Zamość

Other trials in Poland

Estonia4 sites

  • East Viru Central Hospital, Surgery Clinic

    Kohtla-Järve

  • East Tallinn Central Hospital, Department of Internal Medicine

    Tallinn

  • West Tallinn Central Hospital, Department of Urology

    Tallinn

  • Tartu University Hospital, Surgery Clinic, Department of Urology and Renal Transplantation

    Tartu

Other trials in Estonia

South Africa4 sites

  • Lakeview Hospital

    Benoni

  • Clinresco Centres

    Kempton Park

  • Mzansi Ethical Research Centre

    Middleburg

  • St. Georges Hospital

    Port Elizabeth

Other trials in South Africa

Colombia2 sites

  • Fundacion Cardiomet

    Armenia

  • De la Costa Clinic. Ltd. Research Centre

    Barranquilla

Other trials in Colombia

Greece2 sites

  • Evaggelismos Hospital

    Kolonaki

  • Papageorgiou General Hospital

    Thessaloniki

Other trials in Greece

Mexico2 sites

  • Hospital Civil Fray Antonio Alcalde

    Guadalajara

  • Hospital Civil Guadalajara Dr. Juan I. Mendoza

    Guadalajara

Other trials in Mexico

Moldova2 sites

  • National Scientific Practical Center for Emergency Medicine, Department of Urology

    Chisinau

  • Republican Clinical Hospital, Department of Urology

    Chisinau

Other trials in Moldova

Israel1 site

  • Zion Medical Center

    Haifa

Other trials in Israel

Italy1 site

  • Hospital Mater Domini

    Castellanza

Other trials in Italy

About this study

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

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).

Read the 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.

Conditions
cUTI
Being tested
Eravacycline, Levofloxacin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EravacyclineDrug

    Also called TP-434

  • LevofloxacinDrug

    Also called Levaquin

Study groups in NCT01978938
Study groupRoleWhat they receive
EravacyclineExperimentalEravacycline was administered IV at a dose of 1.5 mg per kilogram (kg) of body weight every 24 hours (q24h). At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 200 mg PO twice a day for a total therapy of 7 dosing cycles.
Receives: Drug: Eravacycline
LevofloxacinActive comparatorLevofloxacin (750 mg) was administered IV q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 750 mg PO once a day for a total therapy of 7 dosing cycles.
Receives: Drug: Levofloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: PT Visit

Secondary outcomes (2)

  1. 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.

    Measured: PT Visit

  2. 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.

    Measured: PT Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2013 (estimated)
  2. Study start6 Oct 2014
  3. Primary completion3 Jun 2015
  4. Study completion21 Aug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
908 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01978938
Sponsor's protocol ID
TP-434-010
Status last verified
Dec 2021
First submitted
28 Oct 2013
Last updated
11 Jan 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eravacycline and Levofloxacin in people with cUTI, run by Tetraphase Pharmaceuticals, Inc at 99 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in Ukraine, Russia, Bulgaria, Romania, United States and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants In The Microbiological Intent-To-Treat (Micro-ITT) Population With A Responder Outcome At The Post-Treatment (PT) Visit (time frame: PT Visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01978938.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.

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