Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00008816

Trial Description

start of 1:1-Block title

Title

A Multicenter, Double-blind, Randomized, Clinical Study to Assess the Efficacy and Safety of Intravenous S-649266 in Complicated Urinary Tract Infections With or Without Pyelonephritis or Acute Uncomplicated Pyelonephritis Caused by Gram-Negative Pathogens in Hospitalized Adults in Comparison With Intravenous Imipenem/Cilastatin

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The purpose of this study is to determine the efficacy and safety of intravenous S-649266
versus intravenous imipenem/cilastatin in hospitalized adults with complicated urinary tract
infections with or without pyelonephritis or acute uncomplicated pyelonephritis caused by
Gram-negative pathogens.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00008816
  •   2015/08/11
  •   2014/11/11
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT02321800  (ClinicalTrials.gov)
  •   1409R2121  (Shionogi)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Urinary Tract Infections
  •   N39.0 -  Urinary tract infection, site not specified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: S-649266
  •   Drug: Imipenem/cilastatin
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Composite of Clinical Cure and Microbiologic Eradication; time frame: Baseline and at Test of Cure (TOC; 7 days after end of treatment [EOT], equivalent to Study Day 14-21); Clinical and Microbiologic Response: Resolution or improvement of the symptoms of cUTI present at trial entry (and no new symptoms) and the demonstration that the bacterial pathogen found at trial entry is reduced to fewer than 10^4 CFU/mL on urine culture at the TOC (microbiological success).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Microbiologic response per pathogen and per patient at early assessment (EA), EOT, TOC, and follow-up (FUP); time frame: Baseline and Early Assessment (EA; Day 4), EOT (Day 7-14), TOC (Day 14-21), and at Follow-up (FUP; 14 days after end of treatment; equivalent to Study Days 21-28); Eradication in microbiological outcomes (microbiological success), where eradication is defined as a urine culture that shows the bacterial uropathogen(s) found at entry at ≥ 10^5 CFU/mL are reduced to < 10^4 CFU/mL. A microbiological response per pathogen will be determined for each pathogen isolated at baseline. A microbiological response per patient will be determined for each patient based on individual responses.
- Clinical response per pathogen and per patient at EA, EOT, TOC, and FUP; time frame: Baseline and EA (Day 4), EOT (Day 7-14), TOC (Day 14-21), and FUP (Days 21-28); Clinical cure in clinical outcomes (resolution of the signs and symptoms of complicated urinary tract infection [cUTI] or return to pre-infection baseline if known). A clinical response per pathogen will be determined for each pathogen isolated at baseline. A clinical response per patient will be determined for each patient based on individual responses.
- Plasma concentration of S-649266; time frame: On Day 3 of dosing; plasma sampling prior to infusion, within 15 minutes prior to end of infusion, and at 2 hours post infusion; Plasma concentration of S-649266 at steady state
- Urine concentrations of S-649266; time frame: Urine sampling 2 hours and 6 hours after end of infusion; Urine concentration of S-649266 at steady state
- Number of participants with adverse events; time frame: From Baseline to the Safety Follow-up visit 28 days after end of treatment; equivalent to study Day 35 to 42

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Bulgaria
  •   Croatia
  •   Czech Republic
  •   Georgia
  •   Germany
  •   Hungary
  •   Italy
  •   Japan
  •   Latvia
  •   Poland
  •   Romania
  •   Russian Federation
  •   Spain
  •   United States
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2014/12/31
  •   300
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Hospitalized male and female patients ≥ 18 years

- Clinical diagnosis of either complicated urinary tract infections (cUTI) with or
without pyelonephritis or acute uncomplicated pyelonephritis

- cUTI diagnosed with a history of ≥ 1 of the following: indwelling urinary catheter or
recent instrumentation of the urinary tract, Urinary retention (caused by benign
prostatic hypertrophy), urinary retention of at least 100 mL or more of residual
urine after voiding (neurogenic bladder), obstructive uropathy, and azotemia caused
by intrinsic renal disease (blood urea nitrogen and creatinine values greater than
normal laboratory values)

- At least 2 of the following signs or symptoms: chills or rigors or warmth associated
with fever (temperature greater than or equal to 38 degrees Celsius), flank pain
(pyelonephritis) or suprapubic/pelvic pain (cUTI), nausea or vomiting, dysuria,
urinary frequency, or urinary urgency, and costo-vertebral angle tenderness on
physical examination

- Urinalysis evidence of pyuria demonstrated by dipstick analysis positive for
leukocyte esterase or ≥10 white blood cells (WBCs) per μL in unspun urine, or ≥ 10
WBCs per high power field in spun urine

- Positive urine culture within 48 hours prior to randomization containing ≥10^5 colony
forming unit (CFU)/mL of a Gram-negative uropathogen likely to be susceptible to
imipenem (IPM)

- Patients who were treated with an effective antibiotic for no more than 24 hours
during the previous 72 hours

- Patients who failed treatment, both clinically and microbiologically, and have an
identified uropathogen which is non-susceptible to the empiric treatment and is a
Gram-negative uropathogen likely to be susceptible to IPM

- Subjects receiving antibiotic prophylaxis for UTI who present with signs and symptoms
consistent with an active new UTI

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Urine culture identifies only a Gram-positive pathogen and/or a Gram-negative
uropathogen resistant to IPM

- Urine culture at study entry isolates more than 2 uropathogens or patient has a
confirmed fungal UTI

- Asymptomatic bacteriuria, the presence of >10^5 CFU/mL of a uropathogen and pyuria
but without local or systemic symptoms

- Patient is receiving hemodialysis or peritoneal dialysis

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Shionogi
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Shionogi
    • Shionogi Clinical Trials Administrator Clinical Support Help Line 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Shionogi Clinical Trials Administrator Clinical Support Help Line 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.