Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3 for Gram-negative Bacterial Infection

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Gram-negative Bacterial InfectionPart B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3 - Drug
Eligibility
No minimum age - 88
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study how well ceftazidime-avibactam works and how safe it is in hospitalized infants and neonates.

Eligible Conditions
  • Gram-negative Bacterial Infection

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 10 Secondary · Reporting Duration: Part B: Day 2 until Late Follow-up Visit (up to a maximum study duration of 49 days).

Day 35
Part A: Number of deaths reported for study subjects
Part A: Number of subjects discontinued due to adverse events (AEs)
Part A: Number of subjects with adverse events (AEs) and Serious Adverse Events (SAEs)
Part A: Number of subjects with clinically significant abnormal laboratory results
Part A: Day 1-2.
Ceftazidime
Day 49
Part B: Number of deaths reported for study subjects
Part B: Number of subjects discontinued due to adverse events (AEs)
Part B: Number of subjects with adverse events (AEs) and Serious Adverse Events (SAEs)
Part B: Number of subjects with clinically significant abnormal laboratory results
Day 49
Part B efficacy assessment: All-cause mortality
Part B efficacy assessment: Clinical outcome assessed as proportion of subjects meeting the criteria for clinical cure, clinical improvement, clinical failure, or indeterminate at End-of-IV, End-of-Treatment, Test-of-Cure, and Late Follow-up Visits
Part B efficacy assessment: Cure defined as clinical improvement and no need for further antibacterial treatment, 7 to 14 days after end of treatment
Part B efficacy assessment: Emergent infections
Part B efficacy assessment: Microbiological eradication 7 to 14 days after end of treatment
Day 14
Part B: Ceftazidime and avibactam plasma concentrations by nominal sampling time using appropriate descriptive statistics, eg, number, mean, standard deviation (SD), minimum, median, maximum, geometric mean, and coefficient of variation

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Part A, Cohorts 1-3
1 of 2
Part B, Cohorts 1-3
1 of 2

Experimental Treatment

48 Total Participants · 2 Treatment Groups

Primary Treatment: Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3 · No Placebo Group · Phase 2

Part A, Cohorts 1-3
Drug
Experimental Group · 1 Intervention: Part A: Single Dose Ceftazidime-Avibactam, Cohorts 1-3 · Intervention Types: Drug
Part B, Cohorts 1-3
Drug
Experimental Group · 1 Intervention: Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: part b: day 2 until late follow-up visit (up to a maximum study duration of 49 days).

Who is running the clinical trial?

PfizerLead Sponsor
4,303 Previous Clinical Trials
7,145,467 Total Patients Enrolled
1 Trials studying Gram-negative Bacterial Infection
64 Patients Enrolled for Gram-negative Bacterial Infection
AllerganIndustry Sponsor
781 Previous Clinical Trials
276,105 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,277 Previous Clinical Trials
4,855,373 Total Patients Enrolled
1 Trials studying Gram-negative Bacterial Infection
64 Patients Enrolled for Gram-negative Bacterial Infection

Eligibility Criteria

Age No minimum age - 88 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The subject has given their consent for the study after being fully informed of all its aspects
The subject is willing and able to comply with the study schedule and visit requirements, as well as other study procedures.
Part A of Cohort 1 consists of full term infants with corrected age >28 days to <3 months (<89 days)
The third cohort consists of preterm neonates who were born at or before 26 weeks of gestation and who were still alive at 28 days of age or less.
The person has a bacterial infection that requires intravenous antibiotics.
Cohort 2 includes full-term neonates who were born between 37 and 28 days after conception.
The corrected age is the number of years and weeks since the baby's birth.
The patient's temperature is either too low (hypothermia) or too high (fever).
Heart abnormalities that cause a slow heart rate (bradycardia) or a fast heart rate (tachycardia), or that result in an irregular heart rhythm (rhythm instability).