# Efficacy, Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days With Clinical or Confirmed Late-onset Sepsis

> **NCT01551394** · PHASE3 · COMPLETED · sponsor: **PENTA Foundation** · enrollment: 272 (actual)

## Conditions studied

- Sepsis

## Interventions

- **DRUG:** Meropenem
- **DRUG:** Ampicillin + gentamicin or cefotaxime + gentamicin

## Key facts

- **NCT ID:** NCT01551394
- **Lead sponsor:** PENTA Foundation
- **Sponsor class:** NETWORK
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2012-09
- **Primary completion:** 2014-12
- **Final completion:** 2014-12
- **Target enrollment:** 272 (ACTUAL)
- **Last updated:** 2015-02-16

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01551394

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01551394, "Efficacy, Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days With Clinical or Confirmed Late-onset Sepsis". Retrieved via AI Analytics 2026-06-08 from https://api.ai-analytics.org/clinical/NCT01551394. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
