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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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29 June 2015 |
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Main ID: |
NCT01229553 |
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Date of registration:
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26/10/2010 |
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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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Effect of Topical and Systemic Decolonization of Staphylococcus Aureus (SA) in Pediatric Cystic Fibrosis (CF) Patients
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Scientific title:
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Effect of Topical and Systemic Decolonization of Staphylococcus Aureus (SA) in Pediatric Cystic Fibrosis (CF) Patients at the CF Center at SUNY Upstate Medical University, Syracuse, NY. |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT01229553 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Jana Shaw, 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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State University of New York - Upstate Medical University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Eligible participants will include all patients with CF who test positive for SA from
respiratory tract culture (throat, nares or expectorated sputum) and are 2-23 months of
age at protocol presentation.
Exclusion Criteria:
Patients co-infected with other bacteria (e.g. Pseudomonas) or documented to have an
allergy or resistance to any of the intervention substances will be excluded.
Age minimum:
2 Months
Age maximum:
23 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: decolonization
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Primary Outcome(s)
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To measure the efficacy of a decolonization regimen to eliminate SA from nares, oropharynx and sputum of pediatric CF patients (2-23 months of age).
[Time Frame: 1 year]
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Secondary Outcome(s)
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To measure adverse effects of the decolonization regimen (e.g. local irritation, skin dryness, rashes, vomiting, diarrhea) and its impact on carriage with other organisms (e.g., Pseudomonas).
[Time Frame: 1 year]
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To evaluate the effect of decolonization regimen on lung changes and/or frequency of pulmonary exacerbations.
[Time Frame: 1 year]
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To evaluate adherence to the decolonization regimen
[Time Frame: 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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