Trial Condition(s):
Efficacy and safety of CIPRO XR versus CIPRO IR in patients with Complicated Urinary Tract Infections (EMERON)
11454
Not Available
Not Available
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).
- 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.
- 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
Locations | Status | |
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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 |
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