Trial Condition(s):
Urinary Tract Infection
Efficacy and safety of CIPRO XR versus CIPRO IR in patients with Complicated Urinary Tract Infections (EMERON)
Bayer Identifier:
11454
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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).
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 Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations A.O.U. Federico II Napoli, Italy, 80131 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Consorziale Bari, Italy, 70124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AULSS 03 Bassano Gr - Veneto Bassano del Grappa, Italy, 36061 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale Vittorio Emanuele Catania, Italy, 95124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations P.O. Umberto I Frosinone, Italy, 03100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione San Raffaele Milano, Italy, 20132 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. San Gerardo di Monza Monza, Italy, 20052 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Antonio Cardarelli Napoli, Italy, 80131 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Giaccone Palermo, Italy, 90129 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Ospedale San Carlo Potenza, Italy, 85100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Bianchi-Melacrino-Morelli Reggio Calabria, Italy, 89124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Reggio Emilia Reggio Emilia, Italy, 42100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL Rimini - Emilia Romagna Rimini, Italy, 47900 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Umberto I Roma, Italy, 00155 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL RM/C Roma - Lazio Roma, Italy, 00144 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Università Cattolica del Sacro Cuore Roma, Italy, 00168 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale Villa Scassi Genova, Italy, 16149 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL TO/2 - Piemonte Torino, Italy, 10154 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Ospedali Riuniti Trieste Trieste, Italy, 34149 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Osp Circolo e Fond.Macchi Varese, Italy, 21100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico S.Orsola-Malpighi Bologna, Italy, 40138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Casa Cura Villa Pini d'Abruzzo Chieti, Italy, 66100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. SS Antonio-Biagio-Arrigo Alessandria, Italy, 15100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Gaetano Rummo Benevento, Italy, 82100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinica Gavazzeni Humanitas Bergamo, Italy, 24125 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale Civile di Busto Arsizio Busto Arsizio, Italy, 21052 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale Civile di Samposanpiero Camposampiero, Italy, 35012 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Careggi Firenze, Italy, 50139 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. San Martino Genova, Italy, 16132 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL 4 L'Aquila - Abruzzo L'Aquila, Italy, 67100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Carlo Poma Mantova, Italy, 46100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL 01 Massa-Carrara - Toscana Massa Carrara, Italy, 54100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Papardo di Messina Messina, Italy, 98165 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. San Luigi Gonzaga Orbassano, Italy, 10043 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Policlinico Universitario Monteluce Perugia, Italy, 06122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Policlinico Universitario Sassari Sassari, Italy, 07100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Umberto I di Siracusa Siracusa, Italy, 96100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Ist.Ospitalieri Verona Verona, Italy, 37136 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Sant'Anna-San Sebastiano Caserta, Italy, 81100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit).Timeframe: 5-9 days
Secondary Outcome
- Bacteriological outcome during treatmentTimeframe: 7-14 days
- Bacteriological outcome at follow-upTimeframe: 28-42 days
- Clinical outcome during treatmentTimeframe: 7-14 days
- Clinical outcome at the test-of-cure visitTimeframe: 5-9 days
- Clinical outcome at follow-upTimeframe: 28-42 days
- Adverse event collectionTimeframe: 28-42 days
Additional Information
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