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

NCT00487019 | Completed

• 1 other identifier: 038FAR042005
• Study Type: observational
• Target: 281
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

ampicillin; penicillin G; gentamicin; neonatal sepsis; empiric therapy

Study Arms (2)

1

Neonates aged \<72 h and needing antibacterial therapy for early onset neonatal sepsis

2

Same as group 1

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Neonates hospitalised within 72h of life and requiring empirical antibacterial treatment for early onset neonatal sepsis.

You may qualify if:

• All neonates, admitted to the study NICU-s at the age of less than 72 hours and needing early empiric antibiotic treatment according to pre-defined criteria as described by Schrag et al. (2002)

You may not qualify if:

• Subjects, who on clinical or other indications (e.g. suspected/proven meningitis or abdominal cavity infection, isolation of resistant bacteria from the mother of a neonate with severe sepsis) need antibiotic treatment other than specified in the study protocol and infants who are likely to be transferred to other units within 24 hours.

Sponsors & Collaborators

• University of Tartu: lead
• Estonian Science Foundation: collaborator
• European Society for Paediatric Infectious Diseases: collaborator

Study Sites (2)

Tallinń's Childrens Hospital, Paediatric Intensive Care Unit

Tallinn, Estonia

Location

Tartu University Clinics, Department of Paediatric Intensive Care

Tartu, 50411, Estonia

Location

Related Publications (1)

• Schrag S, Gorwitz R, Fultz-Butts K, Schuchat A. Prevention of perinatal group B streptococcal disease. Revised guidelines from CDC. MMWR Recomm Rep. 2002 Aug 16;51(RR-11):1-22.

  PMID: 12211284 BACKGROUND

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Irja Lutsar, MD, PhD

  University of Tartu

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 14, 2007
• First Posted: June 15, 2007
• Study Start: August 1, 2006
• Study Completion: December 1, 2007
• Last Updated: May 29, 2008

Record last verified: 2008-05

Locations

ES (2)