Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
- Conditions
- Hospital-acquired pneumonia (HAP)/ventilator-associated pneumonia (VAP)/healthcare-associated pneumonia (HCAP) or bloodstream infections/sepsis (BSI/sepsis) caused by carbapenem-resistant Gram-negative pathogens.Complicated urinary tract infection (cUTI) caused by carbapenem-resistant Gram-negative pathogens.MedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: LLTClassification code 10076918Term: Hospital acquired pneumoniaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: LLTClassification code 10065153Term: Ventilator associated pneumoniaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: HLTClassification code 10046577Term: Urinary tract infectionsSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2015-004703-23-GR
- Lead Sponsor
- Shionogi B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
General Inclusion Criteria:
Patients who fulfill the following criteria at Screening will be included in
the study:
1. Hospitalized male and female patients, 18 years or older at the time of
signing informed consent
2. Patients who have provided written informed consent or their
informed consent has been provided by legal guardian (Note: Country
specific rules and local Ethics Committee approval for legal guardian
informed consent will determine whether or not and how a patient
unable to comprehend or sign the informed consent is allowed to be
enrolled in the study)
3. Patients with clinically documented infection (HAP/VAP/HCAP, cUTI,
or BSI/sepsis) caused by a Gram-negative pathogen with evidence of
carbapenem resistance
4. Patients who have been treated previously with an empiric antibiotic
other than the study medications, but failed treatment, both clinically
and microbiologically, are eligible for the study if they have an identified
pathogen which is non-susceptible to the empiric treatment and is a
carbapenem-resistant Gram-negative pathogen before entering this
study
5. Male patients who are sterile or who agreed to use an appropriate
method of contraception from Screening up to 28 days after EOT or
according to country specific requirements, or female patients who are
surgically sterile, are postmenopausal, or females of childbearing
potential who agree to use barrier contraception or who agree to use a
highly-effective method of contraception from Screening up to 28 days
after EOT or according to country specific requirements
6. Patients meeting specific criteria for each infection site
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75
General Exclusion Criteria:
Patients who meet any of the following criteria at Screening will be
excluded from the study:
1.Patients who have a documented history of any moderate or severe
hypersensitivity or allergic reaction to any ß-lactam (Note: for ß-
lactams, a history of a mild rash followed by uneventful re-exposure is
not a contraindication to enrollment)
2.Patients with severe neutropenia, ie, white blood cell (WBC) < 100
cells/µL
3.Patients with APACHE II > 30
4.Patients with any condition or circumstance that, in the opinion of the
investigator, would compromise the safety of the patient or the quality
of the study data
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method