Complicated Urinary Tract InfectionPhase 2NCT00690378

Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections

A Phase 2 study testing NXL104/ceftazidime and Imipenem/Cilastatin in people with Complicated Urinary Tract Infection, run by Pfizer at 59 sites in 3 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

The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated urinary tract infections as compared to a comparator group. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Complicated Urinary Tract Infection
What is being tested?: NXL104/ceftazidime and Imipenem/Cilastatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 137 participants
Where: 59 sitesin 3 countries
Study dates: Nov 2008to Jul 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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Acute pyelonephritis or other complicated urinary tract infection due to gram negative pathogens

Who cannot join

ileal loops or vesicoureteral reflux
complete obstruction of any portion of urinary tract, perinephric or intrarenal abscess.
fungal urinary tract infection
permanent indirect catheter or nephrostomy unless removed within 48 hours of study entry
history hypersensitivity to study medication

Trial locations and contacts

59 sites in 3 countries.

Country

City, postcode or hospital

59 sites in 3 countries

United States42 sites

Summa Health System Hospitals
Akron, Ohio, 44304
Albany Medical Center
Albany, New York, 12208
Mission Hospital
Asheville, North Carolina
Harris Methodist
Azle, Texas
R. Adams Cowley Shock Trauma Center
Baltimore, Maryland
Alabama Research Center
Birmingham, Alabama, 35209
Brookdale University Hospital
Brooklyn, New York
St. James Healthcare
Butte, Montana
Sharp Chula Vista Medical Center
Chula Vista, California, 91911
Southeast Regional Research Group
Columbus, Georgia
Remington-Davis
Columbus, Ohio
Century Clinical Research, Inc
Daytona Beach, Florida
Henry Ford Hospital
Detroit, Michigan, 48202
Southeast Alabama Medical Center
Dothan, Alabama, 36301
Synergy Clinical Research Center
Escondido, California
Novellus Research Sites
Fountain Valley, California
University of Texas MD Anderson
Houston, Texas
University of Florida
Jacksonville, Florida
Regional Infectious Disease-Infusion Center
Lima, Ohio, 45801
Novellus Research Sites
Long Beach, California
North Memorial Medical Center
Minneapolis, Minnesota, 55422
Providence Hospital
Mobile, Alabama, 36608
Modesto Clinical Research
Modesto, California
Jersey Shore University Medical Center
Neptune City, New Jersey, 07754
Christiana Care Health Services
Newark, Delaware
Newark Beth Israel Medical Center
Newark, New Jersey
University Hospital UMDNJ
Newark, New Jersey
Sentara Norfold General Hospital
Norfolk, Virginia
Tri City Medical Center
Oceanside, California, 92056
Four Rivers Clinical Research Inc
Paducah, Kentucky
Thomas Jefferson Univ Hospital
Philadelphia, Pennsylvania
Arizona Pulmonary Specialists LTD
Phoenix, Arizona
Vassar Brothers Medical Center
Poughkeepsie, New York
EStudy Site
San Jose, California
St. Joseph's/Candler Health System
Savannah, Georgia
Louisiana State University Health Services Ctr Shreveport
Shreveport, Louisiana, 71103
Saint Louis University Hospital
St Louis, Missouri
Staten Island University Hospital
Staten Island, New York, 10305
Olive View UCLA Medical Center
Sylmar, California
St Vincent's Mercy Medical Center
Toledo, Ohio, 43608
Reading Hospital and Medical Center
West Reading, Pennsylvania, 19611
Clinical Trials of America Inc.
Winston-Salem, North Carolina, 27103

Other trials in United States

Lebanon13 sites

Clinique due Levant Hospital
Beirut
Dr. Rizk Clinic
Beirut
Makassed General Hospital
Beirut
Rafik Hariri University Hospital
Beirut
Sahel General Hospital
Beirut
Notre Dame Des Secours Hospital
Byblos
Ain Wazein Hospital
Chouf
St. Joseph Hospital
Ed Daoura
Mount Lebanon Hospital
Hazmiyeh
Nabatyeh Governmental Hospital
Nabatyeh
Hammoud Hospital University Medical Center
Saida
Labib Medical Center
Saida
Saida Governmental Hospital
Saida

Other trials in Lebanon

Jordan4 sites

Al-Essra hospital
Amman
Al-Islami Hospital
Amman
Jordan University Hospital
Amman
King Abdullah University Hospital
Irbid

Other trials in Jordan

About this study

Official title: Prospective, Multicenter, Investigator-blinded, Randomized, Comparative Study Estimate Safety, Tolerability, Efficacy of NXL104/Ceftazidime vs. Comparator Followed Appropriate Oral Therapy Treatment Complicated UTI Hosp Adults

The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated urinary tract infections as compared to a comparator group.

Conditions: Complicated Urinary Tract Infection
Being tested: NXL104/ceftazidime, Imipenem/Cilastatin

What participants receive

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

NXL104/ceftazidimeDrug
125mg/500mg TID
Imipenem/CilastatinDrug
4 x daily

Study groups in NCT00690378
Study group	Role	What they receive
1	Experimental	NXL/104 ceftazidime Receives: Drug: NXL104/ceftazidime
2	Active comparator	comparator 4 x daily Receives: Drug: Imipenem/Cilastatin

What is being measured

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

Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Measured: 5 to 9 days post-therapy

Secondary outcomes (19)

Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit
Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required
Measured: End of IV therapy (4 to 14 days)
Clinical Outcome in CE Patients at the TOC Visit
Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required
Measured: 5 to 9 days post-therapy
Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit
Cure: all or most pre-therapy signs and symptoms of the index infection showed no evidence of resurgence and no additional antibiotic was required
Measured: 4 to 6 weeks post-therapy
Microbiological Outcome in ME Patients at the End of IV Therapy Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Measured: End of IV therapy (4 to 14 days)
Microbiological Outcome in ME Patients at the LFU Visit
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
Measured: 4 to 6 weeks post-therapy
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Measured: End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Measured: End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Measured: End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Measured: End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Measured: End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Measured: 5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Measured: 5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Measured: 5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Measured: 5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Measured: 5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
Measured: 4 to 6 weeks post-therapy
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
Measured: 4 to 6 weeks post-therapy
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
Measured: 4 to 6 weeks post-therapy
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
Measured: 4 to 6 weeks post-therapy

Timeline

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

Nov 2008Jul 2010

First posted4 Jun 2008 (estimated)
Study startNov 2008
Primary completionJun 2010
Study completionJul 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Complicated Urinary Tract InfectionStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
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: Single blind
Who is masked: Investigator
Enrolment: 137 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00690378
Sponsor's protocol ID: NXL104/2001
Other IDs: C3591013
Status last verified: Mar 2018
First submitted: 29 May 2008
Last updated: 25 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Vazquez JA, Gonzalez Patzan LD, Stricklin D, Duttaroy DD, Kreidly Z, Lipka J, Sable C. Efficacy and safety of ceftazidime-avibactam versus imipenem-cilastatin in the treatment of complicated urinary tract infections, including acute pyelonephritis, in hospitalized adults: results of a prospective, investigator-blinded, randomized study. Curr Med Res Opin. 2012 Dec;28(12):1921-31. doi: 10.1185/03007995.2012.748653. Epub 2012 Nov 21.
PubMed 23145859

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
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Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children
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A Study to Assess How Vaborem® is Taking up in the Body and Tolerated in Paediatric Patients With Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections
Gram Negative Infections
Not yet recruitingPhase 2
This is a Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ertapenem-zidebactam Versus Ceftazidime-Avibactam in the Treatment of Hospitalized Adult Patients With Complicated Urinary Tract Infection or Acute Pyelonephritis
Complicated Urinary Tract Infections(cUTI), Acute Pyelonephritis
Active, not recruitingPhase 2
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
Acute Pyelonephritis, Complicated Urinary Tract Infection

All Complicated Urinary Tract Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Multicenter, Investigator-blinded, Randomized, Comparative Study Estimate Safety, Tolerability, Efficacy of NXL104/Ceftazidime vs. Comparator Followed Appropriate Oral Therapy Treatment Complicated UTI Hosp Adults
ClinicalTrials.gov ID: NCT00690378
Acronym / sponsor ID: NXL104/2001
Conditions: Complicated Urinary Tract Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 137 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Jun 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 4 Jun 2008 (estimated)
Results: Posted 25 May 2018

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 determine whether NXL104 plus ceftazidime is effective in the treatment of complicated urinary tract infections as compared to a comparator group.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: NXL104/ceftazidimeNXL/104 ceftazidime
2	Active comparator	Drug: Imipenem/Cilastatincomparator 4 x daily

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Acute pyelonephritis or other complicated urinary tract infection due to gram negative pathogens

Key exclusion criteria (5 listed)

ileal loops or vesicoureteral reflux
complete obstruction of any portion of urinary tract, perinephric or intrarenal abscess.
fungal urinary tract infection
permanent indirect catheter or nephrostomy unless removed within 48 hours of study entry
history hypersensitivity to study medication

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
NXL104/ceftazidime125mg/500mg TID	Drug	1
Imipenem/Cilastatin4 x daily	Drug	2

Primary outcome

Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit
Time frame: 5 to 9 days post-therapy
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL

19 secondary outcomes

Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit
Time frame: End of IV therapy (4 to 14 days)
Clinical Outcome in CE Patients at the TOC Visit
Time frame: 5 to 9 days post-therapy
Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit
Time frame: 4 to 6 weeks post-therapy
Microbiological Outcome in ME Patients at the End of IV Therapy Visit
Time frame: End of IV therapy (4 to 14 days)
Microbiological Outcome in ME Patients at the LFU Visit
Time frame: 4 to 6 weeks post-therapy
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit
Time frame: End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit
Time frame: End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit
Time frame: End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit
Time frame: End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit
Time frame: End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit
Time frame: 5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit
Time frame: 5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit
Time frame: 5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit
Time frame: 5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit
Time frame: 5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit
Time frame: 4 to 6 weeks post-therapy
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit
Time frame: 4 to 6 weeks post-therapy
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit
Time frame: 4 to 6 weeks post-therapy
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit
Time frame: 4 to 6 weeks post-therapy

Results and safety

Results posted to the registry on 25 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NXL104/CAZ	69	49
Imipenem Cilastatin	68	54

Primary outcome: Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit

Time frame: 5 to 9 days post-therapy. Number. Unit: Participants

Measure	NXL104/CAZ n = 27	Imipenem Cilastatin n = 35
Value	19	25

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 19 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NXL104/CAZ	6 of 68 (8.8%)	30 of 68 (44.1%)	Not reported
Imipenem Cilastatin	2 of 67 (3%)	33 of 67 (49.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23145859Vazquez JA, Gonzalez Patzan LD, Stricklin D, Duttaroy DD, Kreidly Z, Lipka J, Sable C. Efficacy and safety of ceftazidime-avibactam versus imipenem-cilastatin in the treatment of complicated urinary tract infections, including acute pyelonephritis, in hospitalized adults: results of a prospective, investigator-blinded, randomized study. Curr Med Res Opin. 2012 Dec;28(12):1921-31. doi: 10.1185/03007995.2012.748653. Epub 2012 Nov 21.

Related trials for Complicated Urinary Tract Infection

Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
RecruitingPhase 4
Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children
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A Study to Assess How Vaborem® is Taking up in the Body and Tolerated in Paediatric Patients With Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections
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This is a Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ertapenem-zidebactam Versus Ceftazidime-Avibactam in the Treatment of Hospitalized Adult Patients With Complicated Urinary Tract Infection or Acute Pyelonephritis
Complicated Urinary Tract Infections(cUTI), Acute Pyelonephritis
Active, not recruitingPhase 2
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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.

Pfizer CT.gov Call Center study director

Pfizer

Carole A Sable, MD study director

Novexel Inc

59 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 NXL104/ceftazidime and Imipenem/Cilastatin in people with Complicated Urinary Tract Infection, run by Pfizer at 59 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 1 inclusion and 5 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 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Lebanon, Jordan. 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 25 May 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?

Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit (time frame: 5 to 9 days post-therapy). 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 NCT00690378, which also lists 1 linked publication.

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 May 2018.