Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections (EMERON)

Bayer

Status and phase: Completed; Phase 3

Conditions: Urinary Tract Infection

Treatments: Drug: Cipro XR (Ciprofloxacin, BAYQ3939); Drug: Cipro IR (Ciprofloxacin, BAYQ3939)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00668122

11454

Details and patient eligibility

About

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).

Enrollment: 212 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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212 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Cipro XR (Ciprofloxacin, BAYQ3939)

Arm 2

Experimental group

Treatment:

Drug: Cipro IR (Ciprofloxacin, BAYQ3939)