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NCT01893346 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT01893346: Completed Phase 1 study, sponsored by Pfizer.
NCT01893346 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01893346, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
To assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in children from 3 months of age to \<18 years.
Primary Outcome
Key PK parameters were prespecified to be calculated for cohorts 1 and 2. For cohorts 3 and 4 (where children were \<6 years of age), sparse sampling scheme was used for PK samples to limit the volume of blood required. PK parameters cannot be derived from these sparse PK samples without population PK analysis. Thus the PK is not described here, but will be reported in a separate population PK report.
Interventions
- DRUG CAZ-AVI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
What the finished NCT01893346 record still lists
NCT01893346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 1 intervention - of which CAZ-AVI is the first listed.
NCT01893346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01893346 about?
NCT01893346 is a clinical study titled "Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections". To assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in children from 3 months of age to \<18 years.
What is the current status of trial NCT01893346?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2013-07. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01893346?
The interventions under investigation include: CAZ-AVI (DRUG).
Who is sponsoring clinical trial NCT01893346?
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 NCT01893346's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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