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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: Clinical Trial Phase 2 study, sponsored by Pfizer.
NCT04126031 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT04126031 stopped before completion
NCT04126031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04126031's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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