Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.
Stopped early · Phase 2
Conditions studied: Gram-negative Bacterial Infection
In brief
This study will assess the pharmacokinetics, safety, and tolerability of single and multiple doses of intravenous ceftazidime-avibactam in hospitalized infants and neonates from 26 weeks gestation to 3 months of age. In Part A of the study all patients will receive a single dose of ceftazidime-avibactam. In Part B all patients will received multiple doses of ceftazidime-avibactam. Efficacy will be assessed in the infants and neonates receiving multiple doses of ceftazidime-avibactam.
Key facts
- Study ID
- NCT04126031
- Run by
- Pfizer
- People needed
- 48
- Starts
- 2020-01-14
- Expected to finish
- 2022-12-30
- Last updated by the study team
- 2024-03-26
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Tufts Children's Hospital at Tufts Medical Center — Boston, Massachusetts, United States
- Duke University Investigational Drug Services — Durham, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- University of Utah — Salt Lake City, Utah, United States
- Primary Children's Hospital — Salt Lake City, Utah, United States
- Tallinn Children's Hospital — Tallinn, Estonia
- Athens General Children's Hospital "Panagioti and Aglaias Kyriakou" — Athens, Ampelokipi, Greece
- "ATTIKON" University General Hospital — Chaïdári, Athens, Greece
- "Hippokration" General Hospital of Thessaloniki — Thessaloniki, Greece
- Debreceni Egyetem Klinikai Központ — Debrecen, Hungary
- Kanizsai Dorottya Korhaz — Nagykanizsa, Hungary
- Szabolcs-Szatmár-Bereg Megyei Kórházak és Oktatókórház, Jósa András Oktatókórház — Nyíregyháza, Hungary
- Kasturba Medical College and Hospital — Manipal, Karnataka, India
- Ospedale Pediatrico Bambino Gesu — Rome, RM, Italy
- Univerzitna nemocnica Martin — Martin, Slovakia
- Hsinchu Mackay Memorial Hospital, Department of Pharmacy — Hsinchu, R.o.c, Taiwan
- Hsinchu Mackay Memorial Hospital — Hsinchu, Taiwan
- National Taiwan University Hospital — Taipei, Taiwan
Full record on ClinicalTrials.gov
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