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Management of Early Onset Neonatal Septicaemia: Selection of Optimal Antibacterial Regimen for Empiric Treatment

NCT00487019 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 281

Last updated 2008-05-29

No results posted yet for this study

Summary

A prospective two-center antibiotic regimen switch study will be conducted to compare the clinical efficacy of two antibiotic regimens - penicillin/gentamicin versus ampicillin/gentamicin - in the empirical treatment of early onset neonatal sepsis. The influence of either regimen on bowel colonization pattern and on the development of antibiotic resistance of gut microflora will also be assessed. The primary endpoint is the need for a change in antibacterial treatment within 72 hours of therapy, based on pre-defined criteria. Secondary endpoints will be the incidence rate and etiology of early and late onset neonatal sepsis and susceptibility pattern of causative microorganisms; mortality rate within 60 days; duration of hospitalization in NICU; duration of artificial ventilation; colonization pattern and susceptibility of colonizing bacteria (including resistance to empiric antibiotic regimen).

Conditions

  • Early Onset Neonatal Sepsis

Sponsors & Collaborators

  • Estonian Science Foundation

    collaborator OTHER_GOV

  • European Society for Paediatric Infectious Diseases

    collaborator OTHER

  • University of Tartu

    lead OTHER

Principal Investigators

  • Irja Lutsar, MD, PhD · University of Tartu

Eligibility

Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Completion
2007-12-31

Countries

  • Estonia

Study Locations

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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 NCT00487019 on ClinicalTrials.gov