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Trauma and Critical Care

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SLUHN 2017-33

A Multicenter, Randomized, Double-blind, Parallel-group, Clinical Study of S-649266 Compared With Meropenem for the Treatment of Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, or Healthcare-associated Bacterial Pneumonia Caused by Gram-negative Pathogens

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Erin McLane
    484-526-7963

    erin.mclane@sluhn.org
  • Synopsis: You are invited to be a subject in a research study of the antibiotic S 649266 that is being developed for bacterial infections. This is an experimental drug which means that it is still being tested and is not yet approved for sale. You are being approached as a possible subject in this study because you have been diagnosed with a serious infection that can be treated with antibiotics.

    The study is being performed to determine how safe the experimental drug, S 649266, is and how well it works to treat bacterial infections. “Experimental” means that the study drug is still being tested and has not been approved for use by regulatory authorities (like, the US Food and Drug Administration, European Medicines Agency, and other country authorities) In this consent form, we will refer to the experimental drug, S 649266, as the study drug. Participants in this study will receive either the study drug or a comparator drug (a drug already approved for use) which is an approved antibiotic and can be prescribed by your doctor. Meropenem will be the comparator drug in this study and in this consent form, meropenem will be called the comparator drug. The study is being performed to determine:

    • How well S-649266 treats bacterial infections
    • How safe S-649266 is
    • How your body reacts to S-649266

    This study will look at the effect of the study drug, S 649266, on the infection, and the effect of meropenem (already approved for the treatment of bacterial infections, however it will be used at higher dosage and over a longer infusion time than what is used routinely for this antibiotic – i.e. 2 g every 8 hours instead of 1 g every 8 hours and infused over 3 hours instead of 30 minutes;
    therefore, meropenem will also be considered investigational in this study.

    The study drug will be administered by intravenous infusion (given to you through a vein) up to 4 times per day depending on the health of your kidneys. The comparator drug will be administered by intravenous infusion up to 3 times per day by your study doctor depending on the health of your kidneys according to the drug(s) directions for use that were approved in your country. Participating in a clinical study is not the same as getting regular medical care. The purpose of regular medical care is to improve your health. The purpose of a clinical study is to gather information of the effectiveness and safety of the experimental drug for a specific disease or medical condition. Being in this study does not replace your regular medical care which will continue to be provided. We do not yet know whether treatment with S-649266 is helpful for people with your condition. There is no guarantee that your condition will improve by participating in this study but the results of this study might help people with a similar condition in the future. 

    • Subjects 18 years or older at the time of signing informed consent
    • Subjects who have provided written informed consent or their informed consent has been provided by a legally authorized representative
    • Subjects who meet the clinical diagnosis criteria for hospital-acquired bacterial pneumonia (HABP),ventilator-associated bacterial pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP)
    • All subjects must fulfill at least 1 of the following clinical criteria at screening:
      • New onset or worsening of pulmonary symptoms or signs, such as cough, dyspnea, tachypnea (eg, respiratory rate > 25 breaths/minute), expectorated sputum production, or requirement for mechanical ventilation
      • Hypoxemia (eg, a partial pressure of oxygen [PaO2] < 60 mm Hg while the subject is breathing room air, as determined by arterial blood gas [ABG], or worsening of the ratio of the PaO2 to the fraction of inspired oxygen [PaO2/FiO2])
      • Need for acute changes in the ventilator support system to enhance oxygenation, as determined by worsening oxygenation (ABG or PaO2/FiO2) or needed changes in the amount of positive end-expiratory pressure
      • New onset of or increase in (quantity or characteristics) suctioned respiratory secretions, demonstrating evidence of inflammation and absence of contamination
    • All subjects must have at least 1 of the following signs:
      • Documented fever (ie, core body temperature [tympanic, rectal, esophageal] ≥ 38°C [100.4°F], oral temperature ≥ 37.5°C, or axillary temperature ≥ 37°C)
      • Hypothermia (ie, core body temperature [tympanic, rectal, esophageal] ≤ 35°C [95.0°F], oral temperature ≤ 35.5°C and axillary temperature ≤ 36°C)
      • Leukocytosis with a total peripheral white blood cell (WBC) count ≥ 10,000 cells/mm³
      • Leukopenia with total peripheral WBC count ≤ 4500 cells/mm³
      • Greater than 15% immature neutrophils (bands) noted on peripheral blood smear
    • All subjects must have a chest radiograph during screening showing the presence of new or progressive infiltrate(s) suggestive of bacterial pneumonia. A computed tomography (CT) scan in the same time window showing the same findings could also be acceptable
    • All subjects must have a suspected Gram-negative infection involving the lower respiratory tract
    • Subjects who have known or suspected community-acquired bacterial pneumonia (CABP), atypical pneumonia, viral pneumonia, or chemical pneumonia (including aspiration of gastric contents, inhalation injury)
    • Other exclusions based on the prescribing information of meropenem or linezolid, prior antibiotic usage, age, and pregnancy.