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Sponsors and Collaborators: |
University of Tartu Estonian Science Foundation ESPID Small grant award |
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Information provided by: | University of Tartu |
ClinicalTrials.gov Identifier: | NCT00487019 |
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).
Condition |
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Early Onset Neonatal Sepsis |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Comparative Study of Two Antibiotic Regimen - Penicillin G/Gentamicin Versus Ampicillin/Gentamicin in Empirical Treatment of Early Onset Neonatal Septicaemia |
Enrollment: | 281 |
Study Start Date: | August 2006 |
Study Completion Date: | December 2007 |
Groups/Cohorts |
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1
Neonates aged <72 h and needing antibacterial therapy for early onset neonatal sepsis
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2
Same as group 1
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A prospective randomized two-centre antibiotic regimen switch study will be conducted in the NICU-s of Tartu University Clinics and of Tallinn Children's Hospital. Initially all patients who need empiric treatment for early onset neonatal sepsis (as defined by Schrag et al. 2002) in Tartu will be treated with penicillin/gentamicin and those in Tallinn with ampicillin/gentamicin. When half of the needed subjects have been recruited, departmental antibiotic regimen will be switched so that ampicillin is used in Tartu and penicillin in Tallinn. Based on the present patient population and hospitalization rate, about 120-150 babies, eligible for the study will be admitted to either units every a year.
In all subjects predefined pre- and intranatal risk factors of infection will be registered. During the NICU stay laboratory and clinical signs of infection, need for respiratory support and vasoactive therapy, enteral and parenteral nutrition will be recorded.
Blood, CSF and urine cultures will be taken according to the routine of the ward but certainly before every change in antibacterial treatment. For colonization studies nasopharyngeal or tracheal and anal swabs will be collected from all neonates admitted during the study period on admission and thereafter biweekly until discharge from the NICU or until the 60th day of treatment. A separate protocol will be followed for microbiological investigations.
The endpoints:
The primary endpoint is the need for a change in antibacterial treatment within 72 hours. In discussions with clinical experts in both wards the following criteria for the change in antibacterial treatment were defined:
Secondary endpoints will be the following:
Ages Eligible for Study: | up to 72 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Neonates hospitalised within 72h of life and requiring empirical antibacterial treatment for early onset neonatal sepsis.
Inclusion Criteria:
Exclusion Criteria:
Estonia | |
Tartu University Clinics, Department of Paediatric Intensive Care | |
Tartu, Estonia, 50411 | |
Tallinń's Childrens Hospital, Paediatric Intensive Care Unit | |
Tallinn, Estonia |
Study Chair: | Irja Lutsar, MD, PhD | University of Tartu |
Study ID Numbers: | 038FAR042005 |
Study First Received: | June 14, 2007 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00487019 |
Health Authority: | Estonia: The State Agency of Medicine |
ampicillin penicillin G gentamicin neonatal sepsis empiric therapy |
Systemic Inflammatory Response Syndrome Penicillin G, Procaine Penicillin G Penicillin G, Benzathine |
Sepsis Gentamicins Ampicillin Inflammation |
Protein Synthesis Inhibitors Anti-Infective Agents Anti-Bacterial Agents Pathologic Processes Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Infection Pharmacologic Actions |