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

March2004

January2006

Phase

Could I receive a placebo?

Products

Cipro XR (Ciprofloxacin, BAYQ3939)

Accepts Healthy Volunteers

Where to Participate

Locations

Status

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:

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 treatment
Timeframe: 7-14 days

Bacteriological outcome at follow-up
Timeframe: 28-42 days

Clinical outcome during treatment
Timeframe: 7-14 days

Clinical outcome at the test-of-cure visit
Timeframe: 5-9 days

Clinical outcome at follow-up
Timeframe: 28-42 days

Adverse event collection
Timeframe: 28-42 days

Urinary Tract Infection

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

Trial Purpose

Key Participation Requirements

sex

age

18 Years

No Limit

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

Trial Design

Primary Outcome

Secondary Outcome

Additional Information