Trial to Evaluate the Efficacy and Safety of Cipro® XR in Treating Female Patients With Lower Uri… (NCT00669994) | Clinical Trial Compass
CompletedPhase 4
Trial to Evaluate the Efficacy and Safety of Cipro® XR in Treating Female Patients With Lower Urinary Tract Infections
United States180 participantsStarted 2003-07
Plain-language summary
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.
Who can participate
Age range18 Years – 44 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 t…
What they're measuring
1
Bacteriologic outcome in patients with UTI caused by S. saprophyticus