Efficacy of Betalactam Antibiotics in Prolonged Infusion Compared to Intermittent in Pediatric Patients With Sepsis

NCT03019965 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 426

Last updated 2021-08-05

Study results available
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Summary

This study evaluates the efficacy and safety of the administration of betalactam antibiotics in prolonged infusion compared to intermittent infusion in children with sepsis. Half of participants will receive piperacillin/tazobactam, imipenem or meropenem in continuous or extended infusion, while the other half will receive piperacillin/tazobactam, imipenem or meropenem in intermittent infusion.

Conditions

Interventions

DRUG

Intermittent Piperacillin/tazobactam

Piperacillin/tazobactam administered in 30 minutes infusion.

DRUG

Continuous Piperacillin/tazobactam

Piperacillin/tazobactam administered in 24 hours infusion.

DRUG

Intermittent Imipenem

Imipenem administered in 60 minutes infusion.

DRUG

Extended Imipenem

Imipenem administered in 6 hours infusion.

DRUG

Intermittent Meropenem

Meropenem administered in 60 minutes infusion.

DRUG

Extended Meropenem

Meropenem administered in 8 hours infusion.

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    collaborator OTHER_GOV
  • Hospital Infantil de Mexico Federico Gomez

    collaborator OTHER
  • Hospital Regional de Alta Especialidad del Bajio

    collaborator OTHER
  • Coordinación de Investigación en Salud, Mexico

    lead OTHER_GOV

Principal Investigators

  • Yazmín del Carmen Fuentes · Instituto Mexicano del Seguro Social

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2019-12-30
Completion
2020-01-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

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 NCT03019965 on ClinicalTrials.gov