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Clinical Trials/EUCTR2015-004703-23-ES
EUCTR2015-004703-23-ESActive, not recruitingPhase 1

A Multicenter, Randomized, Open-label Clinical Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens - CREDIBLE

Shionogi Ltd.0 sites150 target enrollmentStarted: December 12, 2016Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
150
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •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
  • •was 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
  • •4. Patients who have been treated previously with an empiric antibiotic regimen and
  • •failed treatment, both clinically and microbiologically, are eligible for the study, if
  • •they have an identified carbapenem-resistant , Gram-negative pathogen which has
  • •either been shown to be nonsusceptible in vitro to each of the antibiotic(s) of the
  • •empiric antibiotic regimen or been grown from a culture performed after at least
  • •two days of the empiric antibiotic regimen
  • •5. Patient is male (no contraception required) or female and meets one of the
  • •following criteria:
  • •- Surgically sterile by hysterectomy and/or bilateral oophorectomy or bilateral
  • •salpingectomy or tubal ligation for the purpose of contraception for at least 6
  • •weeks with appropriate documentation of such surgery
  • •- Postmenopausal (defined as older than 45 years of age with cessation of
  • •regular menstrual periods for 6 months and confirmed by a follicle-stimulating
  • •hormone level of > 40 mIU/ml, or amenorrhea for at least 12 months)
  • •- Of childbearing potential and using combined (estrogen and progestogen) or
  • •progestogen-only hormonal contraception associated with inhibition of
  • •ovulation (including oral, intravaginal, injectable, implantable, and
  • •transdermal contraceptives), or an intrauterine device (IUD), or intrauterine
  • •hormone-releasing system (IUS) for the entire duration of the study
  • •- Of childbearing potential and practice abstinence as a preferred and usual
  • •lifestyle, and agrees to continue practicing abstinence from screening up to 14
  • •days after the last dose of study drug
  • •- Of childbearing potential, whose sole heterosexual partner has been successfully vasectomized and agrees to not have other heterosexual partners
  • •for the entire duration of the study
  • •6. Patients meeting specific inclusion criteria for each infection site (See Diagnosis-
  • •Specific Inclusion Criteria)
  • •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 fo

Exclusion Criteria

  • •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, polymorphonuclear neutrophils (PMNs) < 100 cells/µL
  • •3.Patients with Acute Physiology and Chronic Health Evaluation II (APACHE II) score > 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
  • •5.Patients meeting specific exclusion criteria for each infection site

Investigators

Sponsor
Shionogi Ltd.

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