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Complicated Urinary Tract InfectionPhase 3NCT01345929

Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis

A Phase 3 study testing CXA-201 and Levofloxacin in people with Complicated Urinary Tract Infection and Pyelonephritis, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 76 sites in 17 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, multicenter, prospective, randomized, double-blind, double dummy study of CXA 201 IV infusions (1500 mg q8h) versus levofloxacin IV infusions (750 mg qd) for the treatment of adults with a cUTI (including pyelonephritis). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CXA-201 and Levofloxacin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
558 participants
Where
76 sitesin 17 countries
Study dates
20 Jun 2011to 4 Sep 2013
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

  • Provide written informed consent prior to any study-related procedure not part of normal medical care (a legally acceptable representative may provide consent if the subject is unable to do so, provided this is approved by local country and institution specific guidelines).
  • Be males or females ≥ 18 years of age
  • If female, subject is non-lactating, and is either:
  • Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; or
  • Of childbearing potential and is practicing a barrier method of birth control (e.g., a diaphragm or contraceptive sponge) along with 1 of the following methods: oral or parenteral contraceptives (for 3 months prior to study drug administration), or a vasectomized partner. Or, subject is practicing abstinence from sexual intercourse. Subjects must be willing to practice these methods for the duration of the trial and for at least 35 days after last dose of study medication.
  • Males are required to practice reliable birth control methods (condom or other barrier device) during the conduct of the study and for at least 35 days after last dose of study medication.
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  • Pyuria (white blood cell [WBC] count > 10/μL in unspun urine or ≥ 10 per high power field in spun urine).
  • Clinical signs and/or symptoms of cUTI, either of:
  • Pyelonephritis, as indicated by at least 2 of the following:
  • Documented fever (oral temperature > 38°C) accompanied by patient symptoms of rigors, chills, or "warmth";
  • Flank pain;
  • Costovertebral angle tenderness or suprapubic tenderness on physical exam; or
  • nausea or vomiting; OR
  • Complicated lower UTI, as indicated by at least 2 of the following:
  • At least 2 of the following new or worsening symptoms of cUTI:
  • Dysuria; urinary frequency or urinary urgency;
  • Documented fever (oral temperature > 38°C) accompanied by patient symptoms of rigors, chills, or "warmth";
  • Suprapubic pain or flank pain;
  • Costovertebral angle tenderness or suprapubic tenderness on physical exam; or
  • Nausea or vomiting; plus,
  • At least 1 of the following complicating factors:
  • Males with documented history of urinary retention;
  • Indwelling urinary catheter that is scheduled to be removed during IV study therapy and before the EOT;
  • Current obstructive uropathy that is scheduled to be medically or surgically relieved during IV study therapy and before the EOT; or
  • Any functional or anatomical abnormality of the urogenital tract (including anatomic malformations or neurogenic bladder) with voiding disturbance resulting in at least 100 mL residual urine.
  • Have a pretreatment baseline urine culture specimen obtained within 24 hours before the start of administration of the first dose of study drug.
  • NOTE: Subjects may be enrolled in this study and start IV study drug therapy before the Investigator knows the results of the baseline urine culture.
  • Require IV antibacterial therapy for the treatment of the presumed cUTI.

Who cannot join

  • Have a documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam or quinilone antibacterial (Note: for β-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment)
  • Have a concomitant infection at the time of randomization, which requires non-study systemic antibacterial therapy in addition to IV study drug therapy. (Drugs with only gram-positive activity [e.g., vancomycin, linezolid] are allowed.)
  • Receipt of any amount of potentially therapeutic antibacterial therapy after collection of the pretreatment baseline urine culture and before administration of the first dose of study drug.
  • Receipt of any dose of a potentially therapeutic antibacterial agent for the treatment of the current UTI within 48 hours before the study-qualifying pretreatment baseline urine is obtained (exceptions: subjects with an active cUTI who have received prior antibiotics may be enrolled provided a minimum of 48 hours have elapsed between the last dose of the prior antibiotic and the time of obtaining the baseline urine specimen. Subjects receiving current antibiotic prophylaxis for cUTI who present with signs and symptoms consistent with an active new cUTI may be enrolled provided all other eligibility criteria are met including obtaining a pre-treatment qualifying baseline urine culture).
  • Intractable urinary infection at baseline that the Investigator anticipates would require more than 7 days of study drug therapy.
  • Complete, permanent obstruction of the urinary tract.
Show all 20Show fewer
  • Confirmed fungal urinary tract infection at time of randomization (with ≥ 103 fungal CFU/mL).
  • Permanent indwelling bladder catheter or urinary stent including nephrostomy.
  • Suspected or confirmed perinephric or intrarenal abscess.
  • Suspected or confirmed prostatitis.
  • Ileal loop or known vesico-ureteral reflux.
  • Severe impairment of renal function including an estimated CrCl < 30 mL/min, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (< 20 mL/h urine output over 24 hours).
  • Current urinary catheter that is not scheduled to be removed before the EOT (intermittent straight catheterization during the IV study drug administration period is acceptable).
  • Any condition or circumstance that, in the opinion of the Investigator, would compromise the safety of the subject or the quality of study data.
  • Any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure, respiratory failure, and septic shock.
  • Immunocompromising condition, including established AIDS, hematological malignancy, or bone marrow transplantation, or immunosuppressive therapy including cancer chemotherapy, medications for prevention of organ transplantation rejection, or the administration of corticosteroids equivalent to or greater than 40 mg of prednisone per day administered continuously for more than 14 days preceding randomization.
  • One or more of the following laboratory abnormalities in baseline specimens: aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), alkaline phosphatase, or total bilirubin level greater than 3 times the upper limit of normal (ULN), absolute neutrophil count less than 500/μL, platelet count less than 40,000/μL, or hematocrit less than 20%.
  • Participation in any clinical study of an investigational product within 30 days prior to the proposed first day of study drug.
  • Previous participation in any study of CXA-101 or CXA-201.
  • Women who are pregnant or nursing.

Trial locations and contacts

76 sites in 17 countries.

76 sites in 17 countries

Hungary9 sites

  • Study site

    Budapest

  • Study site

    Gyor, Budapest

  • Study site

    Miskolc, Borsod-Abauj Zemplen county

  • Study site

    Nyíregyháza, Szabolcs-Szatmár-Bereg

  • Study site

    Salgótarján, Nógrád megye

  • Study site

    Sopron, Győr-Moson-Sopron

  • Study site

    Szentes, Csongrád megye

  • Study site

    Tatabánya

  • Study site

    Zalaegerszeg, Zala County

Other trials in Hungary

Brazil7 sites

  • Study site

    Belo Horizonte, Minas Gerais

  • Study site

    Campinas, São Paulo

  • Study site

    Joinville, Santa Catarina

  • Study site

    Porto Alegre, Rio Grande de Sul

  • Study site

    Rio de Janeiro

  • Study site

    Sao Jose de Rio Preto, São Paulo

  • Study site

    São Paulo

Other trials in Brazil

Romania7 sites

  • Study site

    Brasov

  • Study site

    Bucharest, Bucharest

  • Study site

    Bucharest

  • Study site

    Iași

  • Study site

    Oradea, Bihor County

  • Study site

    Sibiu

  • Study site

    Timișoara, Timiș County

Other trials in Romania

Russia7 sites

  • Study site

    Kemerovo

  • Study site

    Moscow

  • Study site

    Nizhny Novgorod

  • Study site

    Novosibirsk

  • Study site

    Penza

  • Study site

    Saint Petersburg

  • Study site

    Saratov

Other trials in Russia

Israel6 sites

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Kfar Saba, Sharon

  • Study site

    Petah Tikva, Teah Tiqwa

  • Study site

    Safed

  • Study site

    Tel HaShomer, Tel Aviv

Other trials in Israel

United States5 sites

  • Study site

    Charleston, South Carolina

  • Study site

    Hialeah, Florida

  • Study site

    San Diego, California

  • Study site

    Teaneck, New Jersey

  • Study site

    Wheat Ridge, Colorado

Other trials in United States

Latvia5 sites

  • Study site

    Daugavpils

  • Study site

    Liepāja

  • Study site

    Riga

  • Study site

    Valmiera

  • Study site

    Ventspills

Other trials in Latvia

Slovakia5 sites

  • Study site

    Banská Bystrica

  • Study site

    Levice

  • Study site

    Martin

  • Study site

    Prešov

  • Study site

    Skalica

Other trials in Slovakia

South Africa5 sites

  • Study site

    Bellville, Western Cape

  • Study site

    Bloemfontein, Free State

  • Study site

    Middleburg, Mpumalanga

  • Study site

    Pretoria, Gauteng

  • Study site

    Soweto, Gauteng

Other trials in South Africa

Colombia4 sites

  • Study site

    Armenia

  • Study site

    Barranquilla

  • Study site

    Bogotá

  • Study site

    Cali, Valle del Cauca Department

Other trials in Colombia

Mexico4 sites

  • Study site

    Chihuahua City

  • Study site

    Guadalajara, Jalisco

  • Study site

    San Luis Potosí City

  • Study site

    Veracruz

Other trials in Mexico

Thailand4 sites

  • Study site

    Chiang Mai

  • Study site

    Lopburi

  • Study site

    Nakorn Ratchasima, Changwat Nakhon Ratchasima

  • Study site

    Prachuap Khiri Khan

Other trials in Thailand

Estonia3 sites

  • Study site

    Kohtla-Järve

  • Study site

    Tallinn

  • Study site

    Tartu

Other trials in Estonia

Germany2 sites

  • Study site

    Giessen, Hesse

  • Study site

    Lübeck, Schleswig-Holstein

Other trials in Germany

Georgia1 site

  • Study site

    Tbilisi

Other trials in Georgia

Moldova1 site

  • Study site

    Chisinau

Other trials in Moldova

Serbia1 site

  • Study site

    Belgrade

Other trials in Serbia

About this study

Official title: A Multicenter, Double-Blind, Randomized, Phase 3 Study to Compare the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis

This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA 201 IV infusions (1500 mg q8h) versus levofloxacin IV infusions (750 mg qd) for the treatment of adults with a cUTI (including pyelonephritis).

Read the detailed description

Approximately 500 subjects will be enrolled into this study and randomized 1:1 to receive CXA-201 or comparator (levofloxacin) resulting in 250 subjects per treatment arm. Subject participation will require a minimum commitment of 35 days and a maximum of 42 days. Subjects will be hospitalized for the administration of all doses of IV study therapy. A test of cure visit will occur at 7 days after the last dose of study drug and a late follow-up evaluation or contact will occur a minimum of 28 days and a maximum of 35 days after the last dose of study drug.

Being tested
CXA-201, Levofloxacin
Keywords
cUTI
Medical subject headings
Pyelonephritis

What participants receive

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

  • CXA-201Drug

    CXA-201 IV infusion (1500mg q8) for 7 days

  • LevofloxacinDrug

    Levofloxacin IV infusion (750mg qd) for 7 days

Study groups in NCT01345929
Study groupRoleWhat they receive
CXA-201 as treatment for cUTIExperimentalCXA-201 IV infusion (1500mg q8) for 7 days
Receives: Drug: CXA-201
Levofloxacin as treatment for cUTIActive comparatorLevofloxacin IV infusion (750mg qd) for 7 days
Receives: Drug: Levofloxacin

What is being measured

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

  1. The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population

    Measured: Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)

Secondary outcomes (1)

  1. The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population.

    Measured: Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)

Timeline

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

  1. First posted2 May 2011 (estimated)
  2. Study start20 Jun 2011
  3. Primary completion11 Aug 2013
  4. Study completion4 Sep 2013

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
558 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01345929
Sponsor's protocol ID
7625A-005
Other IDs
CXA-cUTI-10-04, CXA-cUTI-10-05
Status last verified
Sep 2018
First submitted
28 Apr 2011
Last updated
25 Oct 2018
Data monitoring committee
No
Individual data sharing
Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Popejoy MW, Long J, Huntington JA. Analysis of patients with diabetes and complicated intra-abdominal infection or complicated urinary tract infection in phase 3 trials of ceftolozane/tazobactam. BMC Infect Dis. 2017 May 2;17(1):316. doi: 10.1186/s12879-017-2414-9.

    PubMed 28464828

  • Xiao Y, Tong ML, Liu LL, Lin LR, Chen MJ, Zhang HL, Zheng WH, Li SL, Lin HL, Lin ZF, Xing HQ, Niu JJ, Yang TC. Novel predictors of neurosyphilis among HIV-negative syphilis patients with neurological symptoms: an observational study. BMC Infect Dis. 2017 Apr 26;17(1):310. doi: 10.1186/s12879-017-2339-3.

    PubMed 28446129

  • Kullar R, Wagenlehner FM, Popejoy MW, Long J, Yu B, Goldstein EJ. Does moderate renal impairment affect clinical outcomes in complicated intra-abdominal and complicated urinary tract infections? Analysis of two randomized controlled trials with ceftolozane/tazobactam. J Antimicrob Chemother. 2017 Mar 1;72(3):900-905. doi: 10.1093/jac/dkw486.

    PubMed 27999024

  • Armstrong ES, Mikulca JA, Cloutier DJ, Bliss CA, Steenbergen JN. Outcomes of high-dose levofloxacin therapy remain bound to the levofloxacin minimum inhibitory concentration in complicated urinary tract infections. BMC Infect Dis. 2016 Nov 25;16(1):710. doi: 10.1186/s12879-016-2057-2.

    PubMed 27887579

  • Huntington JA, Sakoulas G, Umeh O, Cloutier DJ, Steenbergen JN, Bliss C, Goldstein EJ. Efficacy of ceftolozane/tazobactam versus levofloxacin in the treatment of complicated urinary tract infections (cUTIs) caused by levofloxacin-resistant pathogens: results from the ASPECT-cUTI trial. J Antimicrob Chemother. 2016 Jul;71(7):2014-21. doi: 10.1093/jac/dkw053. Epub 2016 Mar 18.

    PubMed 26994090

  • Wagenlehner FM, Umeh O, Steenbergen J, Yuan G, Darouiche RO. Ceftolozane-tazobactam compared with levofloxacin in the treatment of complicated urinary-tract infections, including pyelonephritis: a randomised, double-blind, phase 3 trial (ASPECT-cUTI). Lancet. 2015 May 16;385(9981):1949-56. doi: 10.1016/S0140-6736(14)62220-0. Epub 2015 Apr 27.

    PubMed 25931244

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CXA-201 and Levofloxacin in people with Complicated Urinary Tract Infection and Pyelonephritis, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 76 sites in 17 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 28 inclusion and 20 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 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in Hungary, Brazil, Romania, Russia, Israel and 12 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 15 Jan 2015). 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?

The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population (time frame: Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)). 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 NCT01345929, which also lists 6 linked publications.

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 25 Oct 2018.

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