Active substances: Ciprofloxacin
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Clinical-cure rates at the test-of-cure visit were 85. At the late-posttreatment visit, microbiological and clinical outcomes were similar for the two treatments and consistent with test-of-cure results.
Both treatments were well tolerated, but the frequencies of nausea and diarrhea were lower in the ciprofloxacin ER group than in the ciprofloxacin IR group nausea, ER. Additionally, ciprofloxacin ER was associated with significantly reduced frequencies of nausea and diarrhea.
Urinary tract infections UTIs account for over 7 million physician office visits mostly for cystitis and 1 million emergency department visits per year in the United States 3, 15, 24, 25, 29.
Ciprofloxacin, a fluoroquinolone antimicrobial agent with a broad spectrum of activity against both gram-negative and gram-positive bacteria, is an effective treatment for a wide variety of bacterial infections, including uUTI 5, 27.
However, gastrointestinal GI adverse events, such as nausea and diarrhea, remain the most common cause of discontinuation of ciprofloxacin therapy 5.
This mechanism of drug delivery markedly contrasts with that of the currently marketed once-daily extended-release ciprofloxacin tablet CIPRO XR, where drug release is complete within 1.
Therefore, the objective of this phase III randomized, controlled trial was to compare the efficacy and safety of once-daily ciprofloxacin ER, 500 mg, with those of immediate-release ciprofloxacin ciprofloxacin IR, 250 mg twice daily, each given for 3 days, for the treatment of acute uUTI in women.
Each patient provided written informed consent prior to undergoing any study procedures.
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