Ceftibuten clinical studies: Difference between revisions
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Acute Bacterial Otitis Media | '''Acute Bacterial Otitis Media''' | ||
Four clinical trials (three domestic, the fourth abroad) have been conducted testing ceftibuten in the treatment of acute bacterial otitis media. Overall, the clinical outcome among patients who had signs and symptoms of acute bacterial otitis media and who were evaluated at approximately 1 to 2 weeks after completing therapy were equivalent to comparators. Tympanocentesis was performed on patients in three of the above-mentioned studies; the bacterial eradication rates of specific pathogens are presented below. | Four clinical trials (three domestic, the fourth abroad) have been conducted testing ceftibuten in the treatment of acute bacterial otitis media. Overall, the clinical outcome among patients who had signs and symptoms of acute bacterial otitis media and who were evaluated at approximately 1 to 2 weeks after completing therapy were equivalent to comparators. Tympanocentesis was performed on patients in three of the above-mentioned studies; the bacterial eradication rates of specific pathogens are presented below. | ||
Latest revision as of 22:08, 30 December 2013
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]
Acute Bacterial Exacerbations of Chronic Bronchitis
Three clinical trials (two domestic, the third abroad) have been conducted testing ceftibuten in the treatment of acute exacerbations of chronic bronchitis (AECB). Overall, the clinical outcome among patients who had signs and symptoms of AECB, who had a gram stain showing a predominance of PMNs and few epithelial cells, and who were evaluated at approximately 1 to 2 weeks after completing therapy were equivalent to comparators. The bacterial eradication rates of specific pathogens are presented below.
Acute Bacterial Otitis Media
Four clinical trials (three domestic, the fourth abroad) have been conducted testing ceftibuten in the treatment of acute bacterial otitis media. Overall, the clinical outcome among patients who had signs and symptoms of acute bacterial otitis media and who were evaluated at approximately 1 to 2 weeks after completing therapy were equivalent to comparators. Tympanocentesis was performed on patients in three of the above-mentioned studies; the bacterial eradication rates of specific pathogens are presented below.
References
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050686s016lbl.pdf