Trial Condition(s):
Trial to evaluate the efficacy and safety of Cipro® XR in treating female patients with lower urinary tract infections
This trial evaluated how effective and safe Cipro XR was in treating female patients with signs and symptoms of a lower urinary tract infections. After 3 days of treatment, patients were evaluated to determine if signs/symptoms disappeared and the infecting bacteria was eliminated.
- Non-pregnant, non-lactating female outpatients between the ages of 18 - 44 years (inclusive) - Patients with at least two of the following clinical signs and symptoms of an uUTI: -- Dysuria -- Frequency -- Urgency -- Suprapubic pain - Patients with onset of symptoms < 72 hours prior to study entry - Patients with one positive pre-treatment clean-catch midstream urine culture at enrollment in the study, defined as > 10000 CFU/mL (study drug treatment is permitted prior to the availability of urine culture results) - Positive leukocyte esterase (LE) (1+ or greater) utilizing a urine dipstick method of analysis - Patients willing to give written informed consent - Cultures must be performed on pre-treatment clean-catch midstream urine (MSU) specimens
- Males - Women who are pregnant, nursing, or not using two medically accepted, effective methods of birth control - Patients with known or suspected hypersensitivity to quinolones - Patients unable to take oral medication for any reason - Patients with an asymptomatic bacteriuria - Patients with complicated UTI, defined as: a clinical syndrome characterized by the development of systemic and local signs and symptoms of fever (> 38.3°C/101°F orally), chills, malaise, flank pain, back pain, or costovertebral angle (CVA) pain or tenderness - Symptoms as outlined in the inclusion criteria occurring in the presence of a functional or anatomical abnormality of the urinary tract or in the presence of urinary catheterization - Patients with symptoms of a UTI within the 4 weeks prior to the present episode - Patients with the onset of symptoms >72 hours prior to study entry - Patients with three or more episodes of any UTI in the past 12 months - Patients with evidence of factors predisposing to the development of UTIs, including calculi, stricture, primary renal disease (e.g. polycystic renal disease), or neurogenic bladder - Patients who received systemic antimicrobial therapy within 48 hours prior to entry - Patients with a neutrophil count < 1000/mm3, CD4 < 200/mm3 or other conditions associated with significant depression in host defense; HIV testing is not mandatory - Patients requiring concomitant systemic antibacterial therapy with agents not specified in this protocol - Patients with a previous history of tendinopathy associated with fluoroquinolones - Patients diagnosed with a rapidly fatal underlying disease (death expected within six months) - Patients requiring concomitant use of theophylline - Patients previously enrolled in this clinical study - Patients taking an investigational drug in the last 30 days
Locations | Status | ||
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Locations Investigative Site Clearwater, United States, 33761 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Beaver, United States, 15009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Sylmar, United States, 91342 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Murray, United States, 84107 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site San Antonio, United States, 78209 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Elizabeth, United States, 07202-3672 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Holmdel, United States, 07733 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Laguna Woods, United States, 92637 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site West Jordan, United States, 84088 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Phoenix, United States, 85023 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Birmingham, United States, 35242 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Yorba Linda, United States, 92886 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Royal Oak, United States, 48073 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Avon, United States, 06001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Camillus, United States, 13031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Salt Lake City, United States, 84121 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Salt Lake City, United States, 84109 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Milford, United States, 01757 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site San Diego, United States, 92182-4701 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Pelham, United States, 35124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site San Luis Obispo, United States, 93401 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Salt Lake City, United States, 84102 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Pembroke Pines, United States, 33024 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Summerville, United States, 29485 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Feasterville Trevose, United States, 19053 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Evansville, United States, 47714 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Hatboro, United States, 19040 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Birmingham, United States, 35205 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Prospective, open label non-comparative, multi-center trial to evaluate the efficacy and safety of Cipro® XR 500 mg once daily for 3 days in treating female patients with acute, uncomplicated, symptomatic lower urinary tract infections
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1