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Main
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Note: This record shows only 22 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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16 December 2017 |
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Main ID: |
NCT01875731 |
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Date of registration:
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10/06/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Bacterial Pneumonia Score (BPS) Guided Antibiotic Use in Children With Pneumonia and Pneumococcal Vaccine
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Scientific title:
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Efficacy of BPS (Bacterial Pneumonia Score) Guided Antibiotic Use in Children With Community Acquired Pneumonia on Reducing Antibiotic Use as Compared to Standard Care Practice (Current Guidelines for CAP) in the Era of Pneumococcal Vaccine |
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Date of first enrolment:
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July 2013 |
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Target sample size:
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66 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01875731 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: Single (Investigator).
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Phase:
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N/A
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Countries of recruitment
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Argentina
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Contacts
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Name:
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Fernando A Torres, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital de Niños Pedro de Elizalde |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children aged 3-60 months assisted as outpatients for non severe community acquired
pneumonia and pneumoccocal vaccine and complete immunisation with pneumoccocal
vaccine.
Exclusion Criteria:
- Wheezing
- Severe pneumonia
- Pulmonary or cardiovascular chronic disease
- Antibiotic use in the previous two weeks
- Hospitalization for any reason in the previous two weeks
Age minimum:
3 Months
Age maximum:
5 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Community Acquired Pneumonia
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Intervention(s)
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Behavioral: BPS
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Behavioral: Guideline
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Primary Outcome(s)
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Use of Antibiotics in Each Group
[Time Frame: At day 7 from baseline]
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Secondary Outcome(s)
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Treatment Failure in Each Group
[Time Frame: 1, 2, 5, 7 and 10 days from baseline]
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Secondary ID(s)
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HGNPE 67-2012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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