Active Ingredients: Ciprofloxacin
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Patients were evaluated at baseline and reevaluated at a test-of-cure visit 4 to 11 days after completion of treatment and at a late-posttreatment visit 4 to 6 weeks after completion of treatment.
Adherence to therapy was assessed by pill count.
Microbiological and clinical efficacy outcomes. The primary efficacy endpoint was microbiological eradication in the efficacy population at the test-of-cure visit.
Secondary efficacy endpoints included additional microbiological outcomes persistence and new infection at the test-of-cure visit, clinical cure and clinical failure at the test-of-cure visit, microbiological outcomes sustained eradication, persistence, recurrence, and new infection at the late-posttreatment visit, and clinical outcomes sustained cure, relapse, and failure at the late-posttreatment visit.
Clinical cure was defined as the resolution of all clinical signs pyuria and hematuria and symptoms dysuria, frequency, urgency, and suprapubic pain of uUTI and no other antibiotic use. Clinical failure was persistence or recurrence of any clinical signs or symptoms after completion of therapy.
Relapse was the recurrence of any clinical signs or symptoms following resolution at the test-of-cure visit.
Adverse events were recorded throughout the study by direct questioning and observation of patients and from the results of physical examinations and clinical laboratory tests.
All adverse events were assessed for severity and possible relationship to the study drug. Microbiologic methods. Clean-catch, midstream urine samples collected at the baseline pretreatment visit were sent to a central laboratory Pathway Diagnostics, Garden Grove, CA, where the urine was cultured by standard techniques for the identification and quantitative determination of uropathogens.
Uropathogens were identified to the species level. Statistical methods.
The modified intent-to-treat mITT population included all randomized patients who met the enrollment criteria for positive urine culture i. Subjects were excluded if they had taken any prescribed medication or over-the-counter drugs within a period of 2 weeks prior to the study.
Overall study design and plan of trial. The study was conducted as a single-center, single-dose, non-placebo-controlled, randomized, non-blinded, crossover trial with eight healthy young male volunteers.
Each volunteer was studied twice and was randomly assigned to receive either ciprofloxacin at 500 mg p. The pharmacokinetics of ciprofloxacin in microdialysates of skeletal muscle and subcutaneous adipose tissue, saliva, capillary and venous plasma, urine, and cantharis-induced skin blisters were measured as described in detail below.
There was a washout phase of at least 1 week between the two treatments.She received her medical degree at see the full article, log in Medicine-Tulsa, where she also completed a family medicine residency.