Clinical trial NCT00668122: Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections
Official title: Efficacy and Safety of Ciprofloxacin Extended-Release 1000 mg Once-Daily Versus Ciprofloxacin Immediate-Release 500 mg Twice-Daily Given 7-14 Days in Patients With Complicated Urinary Tract Infections: Prospective, Randomized, Double-Blind Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Tract Infection
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess and compare the efficacy and safety of ciprofloxacin extended-release (CIPRO XR) tablet 1000 mg PO once-daily (OD) versus ciprofloxacin immediate-release (CIPRO IR) tablet 500 mg PO twice-daily (BID) for 7-14 days in patients with complicated and/or nosocomial urinary tract infections (cUTI).


Eligibility criteria: Inclusion Criteria:

The primary diagnosis in this clinical trial was cUTI in men or non-pregnant women over 18 years of age. Other main inclusion criteria:

* One or more clinical symptoms and signs of a lower UTI: fever (\> 38°C, orally), chills, frequency of micturition, dysuria, urge sensation.
* One or more of the following underlying conditions suggestive of cUTI:
* Indwelling urinary catheter.
* 100 mL of residual urine after voiding.
* Neurogenic bladder.
* Obstructive uropathy due to lithiasis, tumor or fibrosis.
* Acute urinary retention in men.

Exclusion Criteria:

Diagnosis of pyelonephritis supported by clinical signs/symptoms of fever (\>38°C orally), chills and flank pain (all 3 signs/symptoms must be present).

* Have a history of allergy to quinolones
* Are unable to take oral medication
* Have an intractable infection requiring \> 14 days of therapy
* Have a requirement for concomitant administration of sucralfate or divalent and trivalent cations such as iron or antacids containing magnesium, aluminum or calcium
* Have prostatitis or epididymitis
* Have had a renal transplant
* Have ileal loop or vesica- urethral reflux
* Have significant liver or kidney impairment
* Have a history of tendinopathy associated with fluoroquinolones
* Are pregnant, nursing
* Have a history of convulsions or CNS disorders

Primary outcomes:
measure: Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit).
timeFrame: 5-9 days
Secondary outcomes:
measure: Bacteriological outcome during treatment
timeFrame: 7-14 days
measure: Bacteriological outcome at follow-up
timeFrame: 28-42 days
measure: Clinical outcome during treatment
timeFrame: 7-14 days
measure: Clinical outcome at the test-of-cure visit
timeFrame: 5-9 days
measure: Clinical outcome at follow-up
timeFrame: 28-42 days
measure: Adverse event collection
timeFrame: 28-42 days
Other outcomes:
Locations:
city: Monza
country: Italy
state: Milano
city: Camposampiero
country: Italy
state: Padova
city: Orbassano
country: Italy
state: Torino
city: Busto Arsizio
country: Italy
state: Varese
city: Bassano del Grappa
country: Italy
state: Vicenza
city: Alessandria
country: Italy
city: Bari
country: Italy
city: Benevento
country: Italy
city: Bergamo
country: Italy
city: Bologna
country: Italy
city: Caserta
country: Italy
city: Catania
country: Italy
city: Chieti
country: Italy
city: Firenze
country: Italy
city: Frosinone
country: Italy
city: Genova
country: Italy
city: Genova
country: Italy
city: L'Aquila
country: Italy
city: Mantova
country: Italy
city: Massa Carrara
country: Italy
city: Messina
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Palermo
country: Italy
city: Perugia
country: Italy
city: Potenza
country: Italy
city: Reggio Calabria
country: Italy
city: Reggio Emilia
country: Italy
city: Rimini
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Sassari
country: Italy
city: Siracusa
country: Italy
city: Torino
country: Italy
city: Trieste
country: Italy
city: Varese
country: Italy
city: Verona
country: Italy
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: