Complicated Urinary Tract InfectionPhase 2NCT00921024
Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections
A Phase 2 study testing CXA-101 and Ceftazidime in people with Complicated Urinary Tract Infection, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 21 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of intravenous CXA 101 and comparator in complicated urinary tract infection Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Complicated Urinary Tract Infection
- What is being tested?
- CXA-101 and Ceftazidime
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 30 Jun 2009to 11 Mar 2010
- Phase
- Phase 2
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females 18 to 90 years of age, inclusive.
- 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 both of the following: i. Fever (oral temperature ≥ 37.8°C); ii. Flank pain or costovertebral angle tenderness;
- OR
- Complicated lower UTI, as indicated by both of the following: i. At least one of the following new or worsening symptoms:
Show all 16Show fewer
- Dysuria;
- Frequency;
- Suprapubic pain;
- Urgency
- At least one of the following complicating factors:
- Male gender;
- Current bladder instrumentation or indwelling urinary catheter that is expected to be removed during the course of IV study drug administration;
- Obstructive uropathy that is expected to be medically or surgically treated during the course of IV study drug administration;
- Urogenital surgery within 7 days preceding administration of the first dose of study drug;
- Functional or anatomical abnormality of the urogenital tract including anatomic malformations or neurogenic bladder with voiding disturbance of at least 100 mL residual urine.
Who cannot join
- Documented history of any hypersensitivity or allergic reaction to any β-lactam antibacterial
- Concomitant infection requiring systemic antibacterial therapy in addition to IV study drug therapy at the time of randomization. Drugs with only gram-positive activity (e.g. vancomycin, linezolid) are allowed
- Complete, permanent obstruction of the urinary tract
- Confirmed (at time of randomization) fungal urinary tract infection (with ≥ 103 fungal CFU/mL)
- Suspected or confirmed perinephric or intrarenal abscess
- Suspected or confirmed prostatitis
- Known ileal loop or vesico-ureteral reflux
- Women who are pregnant or nursing
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
United States7 sites
Great Falls Clinic, LLP
Butte, Montana, 59701
Remington-Davis, Inc. Clinical Research
Columbus, Ohio, 43215
Atlanta Institute for Medical Research, Inc.
Decatur, Georgia, 30030
Infectious Disease of Indiana, PSC
Indianapolis, Indiana, 46280
Healthcare Partners Medical Group
Los Angeles, California, 90015
Compass Research, LLC
Orlando, Florida, 32806
Mississippi Medical Research, LLC
Picayune, Mississippi, 39466
Germany7 sites
Kreiskrankenhaus Backnang
Backnang, 71522
URO Forschungs GmbH
Berlin, 10115
Uniklinikum Giessen
Giessen, 35392
Evangelisches Krankenhaus Giessen Urologie
Giessen, 35398
Universitätsklinikum Schleswig Holstein Campus Lübeck
Lübeck, 23538
Brüderkrankenhaus St. Josef Paderborn
Paderborn, 33098
Urologische Klinik Dr. Castringius München-Planegg
Planegg, 82152
Poland7 sites
Samodzielny Publiczny Szpital Kliniczny nr 4 Katedra i Klinika Nefrologii
Lublin, 20-954
Wojewódźki Szpital Specjalistyczny nr 1 Oddział Chorób Wewnętrznych
Tychy, 43-100
Szpital Bielański im.Ks. Jerzego Popiełuszki Samodzielny Publiczny Zakład Opieki Zdrowotnej IV Kliniczny Oddzial Chorób Wewnętrznych
Warsaw, 01-809
Szpital Kliniczny Dzieciątka Jezus-Centrum Leczenia Obrażeń Klinika Urologii Ogólnej, Onkologicznej Czynnościowej
Warsaw, 02-005
Szpital Praski p.w. Przemienienia Pańskiego Samodzielny Publiczny Zakład Opieki Zdrowotnej ll Oddział Wewnętrznych
Warsaw, 03-401
Wojewódźki Szpital Specjalistyczny Oddział Nefrologiczny
Wroclaw, 51-124
Samodzielny Publiczny Szpital Wojewódźki im. Papieża Jana Pawła ll Oddział Wewnętrznych Nefrologiczno-Endokrynologiczny ze Stacją Dializ
Zamość, 22-400
About this study
Official title: A Multicenter, Double-blind, Randomized, Phase 2 Study to Compare the Safety and Efficacy of Intravenous CXA-101 and Intravenous Ceftazidime in Complicated Urinary Tract Infection, Including Pyelonephritis
The purpose of this study is to evaluate the safety and efficacy of intravenous CXA 101 and comparator in complicated urinary tract infection
Read the detailed description
This is a Phase 2, multicenter, prospective, randomized, double-blind, comparative efficacy and safety study of IV CXA 101 versus IV ceftazidime for 7 to 10 days.
Subjects are followed up 6 to 9 days after the last dose of study drug to assess clinical signs and symptoms of infection. A Late Follow Up evaluation (21 to 28 days after the last dose of study drug) occurs for those subjects who respond to therapy. The primary assessment of effectiveness is the microbiological response (the eradication at post-therapy of the infectious organism identified at the start of study). An additional assessment of efficacy includes the overall clinical response, which is described as cured, improved, or failed. Safety assessments include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, serum chemistry, and urinalysis) and physical examinations at the start of the study and post-therapy.
- Conditions
- Complicated Urinary Tract Infection
- Being tested
- CXA-101, Ceftazidime
- Keywords
- Complicated Urinary Tract Infection, Pyelonephritis, Antimicrobial, Cephalosporin, Intravenous
- Medical subject headings
- Pyelonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXA-101Drug
intravenous
CeftazidimeDrug
intravenous
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CXA-101 Receives: Drug: CXA-101 |
| 2 | Active comparator | Ceftazidime Receives: Drug: Ceftazidime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population
Microbiological response is eradication for each baseline pathogen
Measured: TOC; 6-9 days after last study drug administration
Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.
Microbiological response is eradication for each baseline pathogen
Measured: TOC; 6-9 days after last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study start30 Jun 2009
- Primary completion25 Feb 2010
- Study completion11 Mar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Complicated Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmad Haidar, MD, Principal investigator, Mississippi Medical Research, LLCRyszard Gellert, MD, Principal investigator, Szpital Bielański im.Ks. Jerzego Popiełuszki Samodzielny Publiczny Zakład Opieki Zdrowotnej IV Kliniczny Oddzial Chorób Wewnętrznych i Pododdział NefrologicznyFlorian Wagenlehner, MD, Principal investigator, Uniklinikum Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921024
- Sponsor's protocol ID
- 7625-001
- Other IDs
- CXA 101-03
- Status last verified
- Sep 2018
- First submitted
- 12 Jun 2009
- Last updated
- 18 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Phase 2 Study to Compare the Safety and Efficacy of Intravenous CXA-101 and Intravenous Ceftazidime in Complicated Urinary Tract Infection, Including Pyelonephritis
- ClinicalTrials.gov ID
- NCT00921024
- Acronym / sponsor ID
- 7625-001
- Conditions
- Complicated Urinary Tract Infection
- Keywords
- Complicated Urinary Tract Infection, Pyelonephritis, Antimicrobial, Cephalosporin, Intravenous
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2009 (actual)
- Primary completion
- 25 Feb 2010 (actual)
- Study completion
- 11 Mar 2010 (actual)
- First posted
- 16 Jun 2009 (estimated)
- Results
- Posted 15 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of intravenous CXA 101 and comparator in complicated urinary tract infection
Detailed description
This is a Phase 2, multicenter, prospective, randomized, double-blind, comparative efficacy and safety study of IV CXA 101 versus IV ceftazidime for 7 to 10 days.
Subjects are followed up 6 to 9 days after the last dose of study drug to assess clinical signs and symptoms of infection. A Late Follow Up evaluation (21 to 28 days after the last dose of study drug) occurs for those subjects who respond to therapy. The primary assessment of effectiveness is the microbiological response (the eradication at post-therapy of the infectious organism identified at the start of study). An additional assessment of efficacy includes the overall clinical response, which is described as cured, improved, or failed. Safety assessments include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, serum chemistry, and urinalysis) and physical examinations at the start of the study and post-therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CXA-101CXA-101 |
| 2 | Active comparator | Drug: CeftazidimeCeftazidime |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Males and females 18 to 90 years of age, inclusive.
- 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:
- OR
- Complicated lower UTI, as indicated by both of the following: i. At least one of the following new or worsening symptoms:
Key exclusion criteria (8 listed)
- Documented history of any hypersensitivity or allergic reaction to any β-lactam antibacterial
- Concomitant infection requiring systemic antibacterial therapy in addition to IV study drug therapy at the time of randomization. Drugs with only gram-positive activity (e.g. vancomycin, linezolid) are allowed
- Complete, permanent obstruction of the urinary tract
- Confirmed (at time of randomization) fungal urinary tract infection (with ≥ 103 fungal CFU/mL)
- Suspected or confirmed perinephric or intrarenal abscess
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CXA-101intravenous | Drug | 1 |
| Ceftazidimeintravenous | Drug | 2 |
Primary outcome
Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population
Time frame: TOC; 6-9 days after last study drug administration
Microbiological response is eradication for each baseline pathogen
Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.
Time frame: TOC; 6-9 days after last study drug administration
Microbiological response is eradication for each baseline pathogen
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad Haidar, MD principal investigator
Mississippi Medical Research, LLC
Ryszard Gellert, MD principal investigator
Szpital Bielański im.Ks. Jerzego Popiełuszki Samodzielny Publiczny Zakład Opieki Zdrowotnej IV Kliniczny Oddzial Chorób Wewnętrznych i Pododdział Nefrologiczny
Florian Wagenlehner, MD principal investigator
Uniklinikum Giessen
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CXA-101 and Ceftazidime in people with Complicated Urinary Tract Infection, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 21 sites in 3 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 16 inclusion and 8 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 18 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 21 sites in United States, Germany, Poland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population (time frame: TOC; 6-9 days after last study drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2018.