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NCT04126031 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.
A Phase 2 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT04126031 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 48 participants.
The verdict
NCT04126031, a Phase 2 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Part A: Single Dose Ceftazidime-Avibactam, Cohorts 1-3
- DRUG Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2020-01-14 |
| Est. Completion | 2022-12-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04126031
The ClinicalTrials.gov registry entry for NCT04126031 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Part A: Single Dose Ceftazidime-Avibactam, Cohorts 1-3 is the first listed.
NCT04126031 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04126031 about?
NCT04126031 is a clinical study titled "Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.". 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-aviba...
What is the current status of trial NCT04126031?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2020-01-14. Estimated completion is 2022-12-30.
What interventions are being tested in trial NCT04126031?
The interventions under investigation include: Part A: Single Dose Ceftazidime-Avibactam, Cohorts 1-3 (DRUG), Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3 (DRUG).
Who is sponsoring clinical trial NCT04126031?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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