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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00926497 |
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Date of registration:
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16/01/2009 |
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Primary sponsor: |
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Public title:
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Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis
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Scientific title:
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Use of Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis: Prospective Randomized Intervention Trial |
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Date of first enrolment:
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June 2005 |
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Target sample size:
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121 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00926497 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Martin Stocker, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital Lucerne, Switzerland |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Term and near-term infants with a gestational age of more than 34 weeks
- Admitted to the Children's Hospital of Lucerne, Switzerland
- Suspected neonatal early-onset sepsis
- Antibiotic therapy
- Parental consent
Exclusion Criteria:
- Surgery in the first 3 days of life
- Severe congenital malformations
- Chromosomal abnormalities
Age minimum:
N/A
Age maximum:
3 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sepsis
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Intervention(s)
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Other: Procalcitonin-guided decision making
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Primary Outcome(s)
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Absolute Duration of Antibiotic Therapy
[Time Frame: 1 month]
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Antibiotic Treatment for More Than 72 Hours
[Time Frame: 1 month]
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Secondary ID(s)
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PCTStocker
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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