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Beta-lactamase inhibitor
Single-dose PK Study of Ceftazidime-Avibactam In Hospitalized Children Receiving Systemic Antibiotics for Nosocomial Pneumonia
Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dose
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug for pneumonia in children aged 3 months to 18 years.
Eligible Conditions
- Hospitalized Children with Pneumonia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Area Under the Curve From Time Zero to Extrapolated Infinite Time of CAZ-AVI (AUCinf)
Clearance (CL) of CAZ-AVI
Volume of Distribution During Terminal Phase (Vz) of CAZ-AVI
+1 moreSecondary study objectives
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants With Clinically Significant Abnormal Laboratory Values
Number of Participants With Clinically Significant Physical Examination Abnormalities
+1 moreSide effects data
From 2015 Phase 3 trial • 486 Patients • NCT017260238%
Nausea
6%
Diarrhoea
4%
Pyrexia
2%
Constipation
2%
Vomiting
2%
Productive cough
1%
Headache
1%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
CAZ-AVI Plus Metronidazole
Meropenem
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ceftazidime-avibactamExperimental Treatment1 Intervention
This arm includes 4 cohorts
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceftazidime-avibactam
2021
Completed Phase 3
~700
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,675 Previous Clinical Trials
28,717,178 Total Patients Enrolled
AbbVieIndustry Sponsor
1,040 Previous Clinical Trials
523,575 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,758,034 Total Patients Enrolled