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

"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."

"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."

"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."

"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)."

"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."

"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."

"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."

"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"

"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"

"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."