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Beta-lactamase inhibitor

Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3 for Gram-Negative Bacterial Infection (NOOR Trial)

Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Bradycardia OR tachycardia OR rhythm instability;
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part b: day 2 until late follow-up visit (up to a maximum study duration of 49 days).
Awards & highlights

NOOR Trial 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

NOOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

NOOR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part b: day 2 until late follow-up visit (up to a maximum study duration of 49 days).
This trial's timeline: 3 weeks for screening, Varies for treatment, and part b: day 2 until late follow-up visit (up to a maximum study duration of 49 days). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ceftazidime
Part B: Number of deaths reported for study subjects
Part B: Number of subjects discontinued due to adverse events (AEs)
+2 more
Secondary outcome measures
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)
+7 more

NOOR Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B, Cohorts 1-3Experimental Treatment1 Intervention
Multi-dose pharmacokinetics. This arm will include three age cohorts.
Group II: Part A, Cohorts 1-3Experimental Treatment1 Intervention
Single dose pharmacokinetics. This arm will include three age cohorts.

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,556 Previous Clinical Trials
10,907,634 Total Patients Enrolled
AllerganIndustry Sponsor
781 Previous Clinical Trials
275,745 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,467 Previous Clinical Trials
8,089,071 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given its okay to use multiple doses of Ceftazidime-Avibactam for Cohorts 1-3?

"Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3 is currently sitting at a 2 on our safety scale. This is due to it being in Phase 2 trials which only have data supporting safety, and no data yet for efficacy."

Answered by AI

How many people total have signed up to be a part of this experiment?

"Forty-eight individuals are required for this clinical trial, all of which must meet the pre-determined inclusion criteria. Those chosen to participate can do so from multiple locations, such as Rutgers Robert Wood Johnson Medical School in New Haven, Connecticut and Yale-New Haven Hospital in Cleveland, Ohio."

Answered by AI

Have other researchers looked into this phenomenon before?

"There are 6 ongoing clinical trials for Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3. These trials are being conducted in 85 cities across 17 countries. The first trial for this medication was completed in 2020 and involved 48 patients. This study successfully completed Phase 2 drug approval and since then, 46 additional studies have been completed."

Answered by AI

What infections does Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3 typically help cure?

"Often, neutropenia is most effectively treated with Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3. This treatment option can also be efficacious for gram negative bacteria, intraabdominal infections, and lower respiratory tract infection (lrti)."

Answered by AI

How many research facilities are conducting this trial?

"As of now, there are 20 patients recruited for this clinical trial. The locations where the trial is taking place include Rutgers Robert Wood Johnson Medical School in New Haven, Yale-New Haven Hospital in Cleveland, University Hospitals Cleveland Medical Center in Jackson and 20 other locations."

Answered by AI

Are young adults eligible for this experiment?

"This trial is only for patients who are less than 3 months old. There are 220 clinical trials specifically catering to this age group and 661 clinical trials for people over the age of 65."

Answered by AI

Are there historical precedents for the current trial involving Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3?

"Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3 was initially studied in the year 2020 at Hsinchu Mackay Memorial Hospital. To date there are a total of 46 completed studies. There are presently 6 actively recruiting trials, with many of these studies running out of New Haven, Connecticut."

Answered by AI

Might I be able to join this medical study?

"This study is recruiting 48 people with bacterial infections aged 0 Days and 88 Days. Most notable, patients should meet the following criteria: Cohort 1: Full term infants (gestational age ≥ 37 weeks) with chronological age >28 days to <3 months (<89 days) or pre-term infants with corrected age >28 days to <3 months (<89 days). A maximum of 3 pre-term corrected age infants may be enrolled in each part (A and B) of Cohort 1. Sites will be notified in writing if this limit is reached., Cohort 3: Pre-term neon"

Answered by AI

What is the goal of this research project?

"The primary outcome of this study will be evaluated over a Part B: Day 1 until Late Follow-up Visit (up to a maximum study duration of 49 days). The primary outcome is to Part A: 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. Secondary outcomes include Part A: Number of subjects discontinued due to adverse events (AEs) which is defined as Evaluate the safety and tolerability of a single intravenous dose of ceftaz"

Answered by AI

Can new enrollees join this experiment at this time?

"The trial is recruiting patients, as evidenced by the listing on clinicaltrials.gov. This study was first posted on 1/15/2020, and has had several updates since then, with the most recent being on 10/4/2022."

Answered by AI
~9 spots leftby Mar 2025