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Urinary Tract InfectionsPhase 2NCT01281462

Comparative Study of Coadministered Ceftaroline Fosamil and NXL104 vs. Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections

A Phase 2 study testing Ceftaroline fosamil and NXL104 (q8h), Ceftaroline fosamil and NXL104 (q12h) and Doripenem in people with Urinary Tract Infections, run by Forest Laboratories at 50 sites in 7 countries.

Completed

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

Official record
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Trial summary

This is a study in adult subjects with complicated urinary tract infection (cUTI) comparing treatment with intravenous (IV) coadministered ceftaroline fosamil and NXL104 versus treatment with IV doripenem. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Tract Infections
What is being tested?
Ceftaroline fosamil and NXL104 (q8h), Ceftaroline fosamil and NXL104 (q12h) and Doripenem
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
217 participants
Where
50 sitesin 7 countries
Study dates
Dec 2010to Jul 2012
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Subjects must meet the following inclusion criteria:
  • Have pyuria (white blood cells in the urine)
  • Clinical signs and/or symptoms of cUTI (including acute pyelonephritis)
  • Have a pretreatment baseline urine culture specimen
  • The subject's infection would require initial treatment with IV antibiotics
  • The subject must require initial hospitalization to manage the cUTI by the standard of care.

Who cannot join

  • Subjects must NOT meet any of the following exclusion criteria:
  • History of any hypersensitivity or allergic reaction to any β-lactam (eg, cephalosporins, penicillins, carbapenems)
  • Confirmed fungal urinary tract infection
  • Intractable UTI anticipated to require more than 10 days of study drug therapy
  • Complete, permanent obstruction of the urinary tract\
  • Permanent indwelling bladder catheter or instrumentation (including nephrostomy) or current urinary catheter that will not be removed during IV study drug administration
Show all 15Show fewer
  • Suspected or confirmed perinephric or intrarenal abscess
  • Suspected or confirmed prostatitis
  • Ileal loops or vesico-ureteral reflux
  • Impairment of renal function including a calculated CrCl of < 30 mL/min, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria
  • Renal transplantation
  • Life expectancy less than 3 months
  • Evidence of significant hepatic, hematological, or immunologic disease or dysfunction
  • Past or current history of epilepsy or seizure disorder
  • Women who are pregnant or nursing

Trial locations and contacts

50 sites in 7 countries.

50 sites in 7 countries

Russia15 sites

  • Investigational Site

    Moscow, 105077

  • Investigational Site

    Moscow, 105425

  • Investigational Site

    Moscow, 111123

  • Investigational Site

    Moscow, 119049

  • Investigational Site

    Moscow, 119992-119435

  • Investigational Site

    Rostov-on-Don, 344022

  • Investigational Site

    Saint Petersburg, 193312

  • Investigational Site

    Saint Petersburg, 194044

  • Investigational Site

    Saint Petersburg, 194291

  • Investigational Site

    Saint Petersburg, 194354

  • Investigational Site

    Saint Petersburg, 195067

  • Investigational Site

    Saint Petersburg, 196247

  • Investigational Site

    Saint Petersburg, 198205

  • Investigational Site

    Saint Petersburg, 199178

  • Investigational Site

    Smolensk, 214018

Other trials in Russia

Poland11 sites

  • Investigational Site

    Bialystok, 15-950

  • Investigational Site

    Bielsko-Biala, 43-316

  • Investigational Site

    Częstochowa, 42-200

  • Investigational Site

    Katowice, 40-073

  • Investigational Site

    Katowice, 40-752

  • Investigational Site

    Lodz, 90-153

  • Investigational Site

    Tychy, 43-100

  • Investigational Site

    Warsaw, 03-401

  • Investigational Site

    Wołomin, 05-200

  • Investigational Site

    Wroclaw, 50-349

  • Investigational Site

    Zamość, 22-400

Other trials in Poland

Germany8 sites

  • Investigational Site

    Berlin, 10117

  • Investigational Site

    Freiburg im Breisgau, 79106

  • Investigational Site

    Giessen, 35385

  • Investigational Site

    Kassel, 34125

  • Investigational Site

    Minden, 32429

  • Investigational Site

    Müllheim, 79379

  • Investigational Site

    Paderborn, 33098

  • Investigational Site

    Planegg, 82152

Other trials in Germany

Bulgaria6 sites

  • Investigational Site

    Plovdiv, 4002

  • Investigational Site

    Rousse, 7002

  • Investigational Site

    Sofia, 1407

  • Investigational Site

    Sofia, 1431

  • Investigational Site

    Sofia, 1606

  • Investigational Site

    Varna, 9002

Other trials in Bulgaria

United States5 sites

  • Investigational Site

    Baltimore, Maryland, 21287

  • Investigational Site

    Detroit, Michigan, 48202

  • Investigational Site

    La Mesa, California, 91942

  • Investigational Site

    Pensacola, Florida, 32504

  • Investigational Site

    San Diego, California, 92120

Other trials in United States

Turkey (Türkiye)4 sites

  • Investigational Site

    Diyarbakır, 21280

  • Investigational Site

    Eskişehir, 26480

  • Investigational Site

    Izmir, 35040

  • Investigational Site

    Izmir, 35340

Other trials in Turkey (Türkiye)

Lebanon1 site

  • Investigational Site

    Beirut

Other trials in Lebanon

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Coadministered Ceftaroline Fosamil and NXL104 Versus Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infection

This is a study in adult subjects with complicated urinary tract infection (cUTI) comparing treatment with intravenous (IV) coadministered ceftaroline fosamil and NXL104 versus treatment with IV doripenem.

Being tested
Ceftaroline fosamil and NXL104 (q8h), Ceftaroline fosamil and NXL104 (q12h), Doripenem, Placebo
Keywords
complicated Urinary Tract Infection, Acute Pyelonephritis
Medical subject headings
Urinary Tract Infections

What participants receive

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

  • Ceftaroline fosamil and NXL104 (q8h)Drug

    Also called Ceftaroline fosamil and Avibactam(NXL104) (q8h)

    600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 8 hours (q8h);

  • Ceftaroline fosamil and NXL104 (q12h)Drug

    Also called Ceftaroline fosamil and Avibactam(NXL104) (q12h)

    600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 12 hours (q12h);

  • DoripenemDrug

    500 mg doripenem IV q8h;

  • PlaceboDrug

    Also called placebo (saline)

    On CXL-MD-02, there were (3) treatment arms (meaning a subject could be randomized to 1 of 3 possible treatment regimens). Each treatment arm contained 1 or 2 placebo doses of IV saline in order to preserve the blind.

Study groups in NCT01281462
Study groupRoleWhat they receive
Ceftaroline fosamil and NXL104 (q8h)ExperimentalNot described
Receives: Drug: Ceftaroline fosamil and NXL104 (q8h); Drug: Placebo
Ceftaroline fosamil and NXL104 (q12h)ExperimentalNot described
Receives: Drug: Ceftaroline fosamil and NXL104 (q12h); Drug: Placebo
DoripenemActive comparatorNot described
Receives: Drug: Doripenem; Drug: Placebo

What is being measured

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

  1. Microbiological response of Microbiologically Evaluable (ME) at Test of Cure (TOC)

    The number and percentage of subjects in each treatment group recorded as having a favorable microbiological response in the ME Population at Test-of-Cure (TOC)

    Measured: 5 to 11 days after last dose of study drug

  2. Evaluate safety

    Evaluate the safety of coadministered IV ceftaroline fosamil and NXL104 in subjects with cUTI. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology and coagulation studies, comprehensive metabolic panel, and urinalysis), vital signs, ECGs, and physical examinations will be provided for each treatment group.

    Measured: from administration of first dose of study drug to the Late -Follow -Up (LFU) visit (28 to 42 days after administration of the last dose of study drug)

Secondary outcomes (1)

  1. Clinical response in CE at Test of Cure

    The number and percentage of subjects in each treatment group classified as clinical cure Clinically Evaluable (CE) Population at TOC

    Measured: 5 to 11 days after last dose of study drug

Timeline

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

  1. First posted24 Jan 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionMar 2012
  4. Study completionJul 2012

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01281462
Sponsor's protocol ID
CXL-MD-02
Status last verified
Jan 2014
First submitted
13 Jan 2011
Last updated
3 Feb 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ceftaroline fosamil and NXL104 (q8h), Ceftaroline fosamil and NXL104 (q12h) and Doripenem in people with Urinary Tract Infections, run by Forest Laboratories at 50 sites in 7 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 6 inclusion and 15 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 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Russia, Poland, Germany, Bulgaria, United States and 2 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 of Microbiologically Evaluable (ME) at Test of Cure (TOC) (time frame: 5 to 11 days after last dose of study drug). 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?

On the ClinicalTrials.gov record for NCT01281462.

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 3 Feb 2014.

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