EUCTR2018-002841-12-GR进行中（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
Pfizer Inc. 235 East 42nd Street, New York, New York 100170 个研究点目标入组 32 人开始时间: 2020年1月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. 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.
- •2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •3. Male or female children age =3 months to <18 years at Screening:
- •a. Cohort 1: age 12 years to <18 years;
- •b. Cohort 2: age 6 years to <12 years;
- •c. Cohort 3: age 2 years to <6 years;
- •d. Cohort 4: age 3 months to <2 years (must be born =37 weeks gestational age).
- •4. Hospitalized, receiving systemic antibiotic therapy for the treatment of a suspected or confirmed HAP, including 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 =48 hours after admission or <7 days after discharge from an inpatient acute or chronic care facility;
- •b. Evidence of new or worsening infiltrate as demonstrated on chest X-ray or other imaging modality that has been performed as part the subject's regular medical care;
- •c. 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.
- •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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 32
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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) =30 mL/min/1.73 m2 calculated using the child’s measured height (length) and serum creatinine with the Bedside Schwartz equation (Schwartz, Munoz, et al., 2009):
- •CrCL (mL/min/1.73 m2) = 0.413 x height (cm) / serum creatinine (mg/dL)
- •6. Documented history of any hypersensitivity or allergic reaction to any ß-lactam antibiotic.
- •7. Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are sexually active and 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 >3 × upper limit of normal (ULN), unless isolated hyperbilirubinemia is directly related to the acute infection or due to known Gilbert’s disease;
- •b. ALT or AST >3 × ULN values used by the laboratory performing the test.
- •Subjects with values >3 × ULN and <5 × ULN are eligible if this value is acute and directly related to the infectious process being treated. This must be documented;
- •c. ALP >3 × ULN. Subjects with values >3 × ULN and <5 × 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 <2 years of age as BMI is not considered a screening tool for healthy weight in children under 2 years of age.
- •12. Treatment with ceftazidime within 12 hours of CAZ-AVI administration or treatment with ceftazidime withi
研究者
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