CTRI/2020/03/023703尚未招募1 期
A Phase 1, Open-Label, Single-Dose Study To Assess The Pharmacokinetics, Safety And Tolerability Of Ceftazidime-Avibactam (CAZ-AVI) In Children From 3 Months To Less Than 18 Years Of Age Who Are Hospitalized And Receiving Systemic Antibiotic Therapy For Suspected Or Confirmed Nosocomial Pneumonia, Including Ventilator-Associated Pneumonia
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Pfizer Inc
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Evidence of a personally signed and dated informed consent document indicating that the subjects 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.
- •2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •3. Male or female children age greater than or equal to 3 months to less than 18 years at Screening:
- •i. Cohort 1 age 12 years to less than 18 years;
- •ii. Cohort 2: age 6 years to less than 12 years;
- •iii. Cohort 3: age 2 years to less than 6 years &
- •iv. Cohort 4: age 3 months to less than 2 years (must be born greater than or equal to 37 weeks gestational age).
- •4. 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):
- •(a) Onset of symptoms greater than or equal to 48 hours after admission or less than 7 days after discharge from an inpatient acute or chronic care facility
- •(b) New or worsening infiltrate on chest X ray;
- •(c) At least 1 of the following systemic signs prior to the initiation of treatment for Nosocomial Pneumonia:
- •(i) Fever (temperature greater than 38°C) or hypothermia (rectal/core temperature less than 35°C)
- •(ii) White blood cell (WBC) count greater than 10,000 cells/mm3, or WBC count less than 4,500 cells/mm3, or greater than 15 percent 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 less than 90 percent or PaO2 less than 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.
- •5. Likely to survive the current illness or hospitalization.
- •6. Sufficient IV access (peripheral or central) to receive study drug and dedicated access for PK sampling.
排除标准
- •1. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
- •2. Participation in other studies involving investigational drug(s) within 30 days prior to study entry and/or during study participation.
- •3. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
- •4. Past or current history of epilepsy or seizure disorder (excluding childhood febrile seizures.
- •5. Severe renal impairment defined as creatinine clearance (CrCL) less than or equal to 30 mL/min/1.73 m2 calculated using the childs measured height (length) and serum creatinine with the Bedside Schwartz equation (Schwartz, Munoz, et al., 2009):3 CrCL (mL/min/1.73 m2) equal to
- •6. Documented history of any hypersensitivity or allergic reaction to any β lactam antibiotic.
- •7. Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of CAZ AVI.
- •8. Acute hepatitis in the prior 6 months, a prior history of cirrhosis, acute hepatic failure, or acute decompensation of chronic hepatic failure; and/or any of the following blood test results, for any individual, when assessed for eligibility:
- •a. Bilirubin greater than 3 times upper limit of normal (ULN), unless isolated hyperbilirubinemia is directly related to the acute infection or due to known Gilberts disease;
- •b. ALT or AST greater than 3 times ULN values used by the laboratory performing the test. Subjects with values greater than 3 times ULN and less than 5 times ULN are eligible if this value is acute and directly related to the infectious process being treated. This must be documented;
- •c. ALP greater than 3 times ULN. Subjects with values greater than 3 times ULN and less than 5 times ULN are eligible if this value is acute and directly related to the infectious process being treated. This must be documented.
- •9. Any condition (eg, septic shock, burns, cystic fibrosis, acute hemodynamic instability, including those conditions not responding to pressor support) that would make the patient, in the opinion of the Investigator, unsuitable for the study (eg, would place a patient at risk; compromise the quality of the data; or interfere with the absorption, distribution, metabolism, or excretion of CAZ AVI).
- •10. Receipt of a blood or blood component or scheduled for transfusion within the PK sampling period (eg, red blood cells, fresh frozen plasma, platelets) transfusion during the 24 hour period before enrollment.
- •11. Body mass index (BMI) below the 5th percentile or above the 95th percentile for height, age, and weight except for children less than 2 years of age as BMI is not considered a screening tool for healthy w
研究者
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