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Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis

NCT02424734 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2018-09-13

Study results available
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Summary

The purpose of this study is to evaluate the safety and tolerability of ceftaroline for the treatment of Late Onset Sepsis in neonates and young infants aged 7 to \<60 days

Conditions

  • Late-onset Sepsis

Interventions

DRUG

Ceftaroline Fosamil

Ceftaroline fosamil will be given at a dose of 6 mg/kg IV over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour).

DRUG

Ampicillin

Ampicillin IV is required for the first 48 hours if the presence of an organism that requires treatment with ampicillin cannot be excluded. Will be given as per local standard of care.

DRUG

Aminoglycoside

Optional, will be given as per local standard of care.

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
7 Days
Max Age
59 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-04
Primary Completion
2017-12-26
Completion
2017-12-26
FDA Drug
Yes

Countries

  • United States
  • Hungary

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02424734 on ClinicalTrials.gov