# Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.

> **NCT04126031** · PHASE2 · TERMINATED · sponsor: **Pfizer** · enrollment: 48 (actual)

## Conditions studied

- Gram-negative Bacterial Infection

## Interventions

- **DRUG:** Part A: Single Dose Ceftazidime-Avibactam, Cohorts 1-3
- **DRUG:** Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3

## Key facts

- **NCT ID:** NCT04126031
- **Lead sponsor:** Pfizer
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2020-01-14
- **Primary completion:** 2022-12-30
- **Final completion:** 2022-12-30
- **Target enrollment:** 48 (ACTUAL)
- **Why stopped:** Following regulatory consultation, the Sponsor has decided to terminate the study and analyze the current dataset. The decision to terminate was solely based on a business decision, not due to safety concerns.
- **Last updated:** 2024-03-26

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04126031

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04126031, "Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT04126031. Licensed CC0.

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