A Randomized, Open-Label Study Comparing Levofloxacin Once-Daily 750 mg PO for 5 Days and Azithromycin Once-Daily 500 mg on Day One and Then 250 mg Days 2 Through 5 In a Microbiologic Evaluation for Emergence of Resistance in the Oropharyngeal Flora of Healthy Subjects
Sponsor study identifier
interventional
143
0 countries
N/A
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
September 2006
Actual (reported)Evaluation of bacteria in the mouth and throat before study drug ( Levofloxacin, floroquinolone antibiotic and Azithromycin, a macrolide antibiotic) is started and then periodically for 6 weeks after the last dose of study drug is taken
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2006
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
September 2006
Actual (reported)January 9, 2009
Actual (reported)January 13, 2009
Actual (reported)The primary endpoint is the emergence or worsening of bacterial resistance in the mouth and throat through six weeks after completion of the antibiotic
All bacterial species cultured from the mouth and throat will be recorded. Each bacterial species seen at baseline, the proportion of subjects in which there was bacterial resistance will be summarized.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Levofloxacin; Azithromycin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordNord CE, Peterson J, Ambruzs M, Fisher AC. Levofloxacin versus azithromycin on the oropharyngeal carriage and selection of antibacterial- resistant streptococci in the microflora of healthy adults. Curr Med Res Opin. 2009 Jun;25(6):1461-7. doi: 10.1185/03007990902953468.
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial
Ortho-McNeil Janssen Scientific Affairs, LLC
143 participants (actual enrollment reported by the registry).
First Submitted
January 9, 2009
First Posted
January 13, 2009
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Oral Ghrelin Agonist in Healthy Subjects
Contact the study team to confirm eligibility.
Study Completion
September 2006
Actual (reported)Last Updated
May 19, 2011
Record last verified: 2010-04
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Source: ClinicalTrials.gov.
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