Cipro® XR in Therapeutic Response and Activity (eXtRa) - Assessing Symptom Relief in Urinary Tract Infections
Cipro® XR in Therapeutic Response and Activity (eXtRa) - Assessing Symptom Relief in Urinary Tract Infections
The primary objective of this clinical trial was to determine the time to improvement of the
 signs and symptoms (eg, dysuria, frequency, urgency, gross hematuria, suprapubic pain,
 hesitancy, low back pain) of acute, uncomplicated, symptomatic, lower UTIs in women treated
 with Cipro XR 500 mg once daily for 3 days.
Inclusion Criteria:- Non-pregnant, non-lactating women between the ages of 18 and 65 years
 with signs and symptoms of acute, uncomplicated, symptomatic lower UTI were eligible for
 enrolment. Dysuria and at least 1 clinical sign or symptom of a lower UTI (frequency,
 urgency, suprapubic pain, or gross hematuria) had to be present, with symptom onset </= 72
 hours before study entry. - In addition, 1 pretreatment clean-catch MSU culture had to be
 positive for 1 to 2 urinary pathogens (>/= 10.000 colony-forming units {CFU}/mL). Women of
 childbearing potential were required to use 2 reliable methods of contraception during
 exposure to study drug. Exclusion Criteria:- Men- Women who were pregnant, nursing, or not
 using 2 medically accepted, effective methods of birth control- Known or suspected
 hypersensitivity to ciprofloxacin or the quinolone class of antimicrobials- Subjects taking
 urinary analgesic medication (phenazopyridine-containing products {eg, Pyridium}) within 24
 hours before first dose of study drug and throughout the study for urinary tract pain-
 Subjects taking other analgesic medications (eg, nonsteroidal anti-inflammatory drugs
 [NSAID], acetaminophen-containing products, etc) for urinary tract pain or any other pain
 (eg, headache, back pain, joint pain, dental pain, sore muscles, etc) within 2 dosing
 intervals for that medication before first dose of study drug and throughout the study.
 More specifically, a subject who had taken a medication for pain could not be entered into
 the study until the time elapsed since her last dose of the medication was equal to at
 least 2 dosing intervals for that medication.- History of gastrointestinal illness that
 could interfere with absorption of orally administered antimicrobials- Subjects requiring
 concomitant administration of multivalent cation-containing products such as
 magnesium/aluminum antacids, sucralfate, Videx (didanosine) chewable/buffered tablets or
 pediatric powder, or products containing calcium, iron, or zinc, such as multivitamin
 preparations. These medications were not to be taken less than 6 hours before or 2 hours
 after study drug administration. - Subjects experiencing vaginitis- Subjects with a
 temperature >/= 38.3°C or >/= 101°F, flank pain, chills, or any other manifestations
 suggestive of upper UTI - Subjects with evidence of factors predisposing to the development
 of UTIs, including calculi, stricture, primary renal disease (eg, polycystic renal
 disease), or neurogenic bladder - Subjects currently taking, or who might require,
 antibiotics other than Cipro XR during the study period- Subjects who had received any
 systemic antibiotic therapy in the previous 48 hours, for any reason- Subjects who, in the
 opinion of the investigator, were unsuitable for enrollment and were unlikely to complete
 the course of treatment or to be available for follow-up- Subjects unable or unwilling to
 comply with the use of an electronic subject diary to record UTI symptoms and impairment of
 normal daily activities- Subjects requiring concomitant administration of theophylline -
 Inability to take oral medication for any reason - Subjects with >/= 3 episodes of UTIs in
 the past 12 months - Subjects with onset of symptoms more than 72 hours prior to study
 entry - Subjects with symptoms of a UTI within the 4 weeks prior to the present episode -
 Subjects with previous history of tendinopathy associated with fluoroquinolones - Subjects
 diagnosed with a rapidly fatal underlying disease (death expected within 6 months) -
 Subjects previously enrolled in this clinical study - Subjects with known neutrophil count
 < 1000/mm3, CD4 < 200/mm3, or other conditions associated with significant depression of
 host defense; HIV testing was not mandatory - Subjects taking an investigational drug in
 the last 30 days - Subjects who could not begin answering the first visit baseline
 questionnaire by 5:00 pm