This is a multicenter, multinational, open label single dose pharmacokinetic (PK) study enrolling at least 32 subjects. The study aims to characterize the pharmacokinetics (PK) of a single intravenous dose of CAZ AVI in pediatric subjects aged 3 months to less than 18 years who are receiving systemic antibiotic therapy for suspected or confirmed nosocomial pneumonia, including ventilator associated pneumonia.
• Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
• Evidence of a personally signed and dated informed consent document indicating that the subject's parent(s), legal guardian, or legally acceptable representative has been informed of all pertinent aspects of the study. As appropriate per local requirements informed assent of subjects must also be documented.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Male or female children age ≥3 months to <18 years at Screening:
• Cohort 1: age 12 years to <18 years;
• Cohort 4: age 3 months to <2 years (must be born ≥37 weeks gestational age).
• Hospitalized, receiving systemic antibiotic therapy for the treatment of a suspected or confirmed HAP or VAP meeting the following criteria, and expected to require hospitalization until after the follow up evaluations are completed on Day 3 (48 hours after the end of infusion):
• Onset of symptoms ≥48 hours after admission or <7 days after discharge from an inpatient acute or chronic care facility;
• New or worsening infiltrate on chest X ray;
• At least 1 of the following systemic signs prior to the initiation of treatment for Nosocomial Pneumonia:
• i. Fever (temperature >38°C) or hypothermia (rectal/core temperature <35°C); ii. White blood cell (WBC) count >10,000 cells/mm3, or WBC count <4,500 cells/mm3, or >15% band forms.
• d. At least 2 of the following respiratory signs or symptoms: i. A new onset of cough (or worsening of cough). ii. Production of purulent sputum or endotracheal secretions. iii. Auscultatory findings consistent with pneumonia/pulmonary consolidation (eg, rales, rhonchi, bronchial breath sounds, dullness to percussion, egophony).
• iv. Dyspnea, tachypnea or hypoxemia (O2 saturation <90% or PaO2 <60 mmHg while breathing room air).
• v. A need for mechanical ventilation or, for already ventilated subjects, acute changes made in the ventilator support system to enhance oxygenation, as determined by, for example arterial blood gas or worsening PaO2/FiO2.
• Likely to survive the current illness or hospitalization.
• Sufficient IV access (peripheral or central) to receive study drug and dedicated access for PK sampling.
This content was sourced from clinicaltrials.gov