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:

NCT00668122

EudraCT Number:

Not Available

Study Completed

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
212
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Cipro XR (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

A.O.U. Federico II

Napoli, Italy, 80131

Status
Completed
 
Locations

A.O.U. Policlinico Consorziale

Bari, Italy, 70124

Status
Completed
 
Locations

AULSS 03 Bassano Gr - Veneto

Bassano del Grappa, Italy, 36061

Status
Completed
 
Locations

Ospedale Vittorio Emanuele

Catania, Italy, 95124

Status
Completed
 
Locations

P.O. Umberto I

Frosinone, Italy, 03100

Status
Terminated
 
Locations

IRCCS Fondazione San Raffaele

Milano, Italy, 20132

Status
Completed
 
Locations

A.O. San Gerardo di Monza

Monza, Italy, 20052

Status
Completed
 
Locations

A.O. Antonio Cardarelli

Napoli, Italy, 80131

Status
Terminated
 
Locations

A.O.U. Policlinico Giaccone

Palermo, Italy, 90129

Status
Completed
 
Locations

A.O. Ospedale San Carlo

Potenza, Italy, 85100

Status
Completed
 
Locations

A.O. Bianchi-Melacrino-Morelli

Reggio Calabria, Italy, 89124

Status
Completed
 
Locations

A.O. di Reggio Emilia

Reggio Emilia, Italy, 42100

Status
Completed
 
Locations

AUSL Rimini - Emilia Romagna

Rimini, Italy, 47900

Status
Terminated
 
Locations

A.O.U. Policlinico Umberto I

Roma, Italy, 00155

Status
Completed
 
Locations

ASL RM/C Roma - Lazio

Roma, Italy, 00144

Status
Completed
 
Locations

Università Cattolica del Sacro Cuore

Roma, Italy, 00168

Status
Completed
 
Locations

Ospedale Villa Scassi

Genova, Italy, 16149

Status
Completed
 
Locations

ASL TO/2 - Piemonte

Torino, Italy, 10154

Status
Completed
 
Locations

A.O.U. Ospedali Riuniti Trieste

Trieste, Italy, 34149

Status
Completed
 
Locations

A.O. Osp Circolo e Fond.Macchi

Varese, Italy, 21100

Status
Terminated
 
Locations

A.O.U. Policlinico S.Orsola-Malpighi

Bologna, Italy, 40138

Status
Completed
 
Locations

Casa Cura Villa Pini d'Abruzzo

Chieti, Italy, 66100

Status
Terminated
 
Locations

A.O. SS Antonio-Biagio-Arrigo

Alessandria, Italy, 15100

Status
Completed
 
Locations

A.O. Gaetano Rummo

Benevento, Italy, 82100

Status
Completed
 
Locations

Clinica Gavazzeni Humanitas

Bergamo, Italy, 24125

Status
Completed
 
Locations

Ospedale Civile di Busto Arsizio

Busto Arsizio, Italy, 21052

Status
Terminated
 
Locations

Ospedale Civile di Samposanpiero

Camposampiero, Italy, 35012

Status
Terminated
 
Locations

A.O.U. Careggi

Firenze, Italy, 50139

Status
Completed
 
Locations

A.O.U. San Martino

Genova, Italy, 16132

Status
Terminated
 
Locations

AUSL 4 L'Aquila - Abruzzo

L'Aquila, Italy, 67100

Status
Completed
 
Locations

A.O. Carlo Poma

Mantova, Italy, 46100

Status
Completed
 
Locations

AUSL 01 Massa-Carrara - Toscana

Massa Carrara, Italy, 54100

Status
Terminated
 
Locations

A.O. Papardo di Messina

Messina, Italy, 98165

Status
Completed
 
Locations

A.O.U. San Luigi Gonzaga

Orbassano, Italy, 10043

Status
Completed
 
Locations

Policlinico Universitario Monteluce

Perugia, Italy, 06122

Status
Completed
 
Locations

Policlinico Universitario Sassari

Sassari, Italy, 07100

Status
Terminated
 
Locations

A.O. Umberto I di Siracusa

Siracusa, Italy, 96100

Status
Completed
 
Locations

A.O.U. Ist.Ospitalieri Verona

Verona, Italy, 37136

Status
Completed
 
Locations

A.O. Sant'Anna-San Sebastiano

Caserta, Italy, 81100

Status
Completed
 

Trial Design