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Single-dose PK Study of Ceftazidime-Avibactam In Hospitalized Children Receiving Systemic Antibiotics for Nosocomial Pneumonia

Last updated on August 5, 2019

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Study Location
Rady Children's Hospital San Diego
San Diego, California, 92123 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hospitalized Children With Suspected or Confirmed Nosocomial Pneumonia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-17 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Subjects must meet all of the following inclusion criteria to be eligible for enrollment
into the study:

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

1. Cohort 1: age 12 years to

2. Cohort 2: age 6 years to

3. Cohort 3: age 2 years to

4. Cohort 4: age 3 months to

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):

1. Onset of symptoms ≥48 hours after admission or inpatient acute or chronic care facility;

2. New or worsening infiltrate on chest X ray;

3. 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 blood cell (WBC) count >10,000 cells/mm3, or WBC count 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 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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Subjects with any of the following characteristics/conditions will not be included in the
study:

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):3 CrCL (mL/min/1.73 m2) =

6. Documented history of any hypersensitivity or allergic reaction to any ? 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:

1. Bilirubin >3 × upper limit of normal (ULN), unless isolated hyperbilirubinemia is
directly related to the acute infection or due to known Gilbert's disease;

2. ALT or AST >3 × ULN values used by the laboratory performing the test. Subjects
with values >3 × ULN and directly related to the infectious process being treated. This must be
documented;

3. ALP >3 × ULN. Subjects with values >3 × ULN and 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 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 within 24 hours of CAZ AVI administration in subjects with renal
impairment (CrCL ?50 mL/min/1.73 m2).

13. Treatment with potent inhibitors of OAT1 and/or OAT3 (eg, probenecid, p aminohippuric
acid (PAH), or teriflunomide).

NCT04040621
Pfizer
Not yet recruiting
Single-dose PK Study of Ceftazidime-Avibactam In Hospitalized Children Receiving Systemic Antibiotics for Nosocomial Pneumonia

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Pfizer Clinical Trials Contact Center

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[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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