check_circleStudy Completed
Urinary Tract Infection
Bayer Identifier:infoA unique number for a trial given by Bayer.
11454
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
Not Available
Efficacy and safety of CIPRO XR versus CIPRO IR in patients with Complicated Urinary Tract Infections
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).
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal info
212The overall number of participants needed for a trial.
Trial Dates info
March 2004 - January 2006Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 3A phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Cipro XR (Ciprofloxacin, BAYQ3939)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
| Status | Institution | Location |
|---|---|---|
Completed | A.O.U. Federico II | Napoli, 80131, Italy |
Completed | A.O.U. Policlinico Consorziale | Bari, 70124, Italy |
Completed | AULSS 03 Bassano Gr - Veneto | Bassano del Grappa, 36061, Italy |
Completed | Ospedale Vittorio Emanuele | Catania, 95124, Italy |
Terminated | P.O. Umberto I | Frosinone, 03100, Italy |
Completed | IRCCS Fondazione San Raffaele | Milano, 20132, Italy |
Completed | A.O. San Gerardo di Monza | Monza, 20052, Italy |
Terminated | A.O. Antonio Cardarelli | Napoli, 80131, Italy |
Completed | A.O.U. Policlinico Giaccone | Palermo, 90129, Italy |
Completed | A.O. Ospedale San Carlo | Potenza, 85100, Italy |
Completed | A.O. Bianchi-Melacrino-Morelli | Reggio Calabria, 89124, Italy |
Completed | A.O. di Reggio Emilia | Reggio Emilia, 42100, Italy |
Terminated | AUSL Rimini - Emilia Romagna | Rimini, 47900, Italy |
Completed | A.O.U. Policlinico Umberto I | Roma, 00155, Italy |
Completed | ASL RM/C Roma - Lazio | Roma, 00144, Italy |
Completed | Università Cattolica del Sacro Cuore | Roma, 00168, Italy |
Completed | Ospedale Villa Scassi | Genova, 16149, Italy |
Completed | ASL TO/2 - Piemonte | Torino, 10154, Italy |
Completed | A.O.U. Ospedali Riuniti Trieste | Trieste, 34149, Italy |
Terminated | A.O. Osp Circolo e Fond.Macchi | Varese, 21100, Italy |
Completed | A.O.U. Policlinico S.Orsola-Malpighi | Bologna, 40138, Italy |
Terminated | Casa Cura Villa Pini d'Abruzzo | Chieti, 66100, Italy |
Completed | A.O. SS Antonio-Biagio-Arrigo | Alessandria, 15100, Italy |
Completed | A.O. Gaetano Rummo | Benevento, 82100, Italy |
Completed | Clinica Gavazzeni Humanitas | Bergamo, 24125, Italy |
Terminated | Ospedale Civile di Busto Arsizio | Busto Arsizio, 21052, Italy |
Terminated | Ospedale Civile di Samposanpiero | Camposampiero, 35012, Italy |
Completed | A.O.U. Careggi | Firenze, 50139, Italy |
Terminated | A.O.U. San Martino | Genova, 16132, Italy |
Completed | AUSL 4 L'Aquila - Abruzzo | L'Aquila, 67100, Italy |
Completed | A.O. Carlo Poma | Mantova, 46100, Italy |
Terminated | AUSL 01 Massa-Carrara - Toscana | Massa Carrara, 54100, Italy |
Completed | A.O. Papardo di Messina | Messina, 98165, Italy |
Completed | A.O.U. San Luigi Gonzaga | Orbassano, 10043, Italy |
Completed | Policlinico Universitario Monteluce | Perugia, 06122, Italy |
Terminated | Policlinico Universitario Sassari | Sassari, 07100, Italy |
Completed | A.O. Umberto I di Siracusa | Siracusa, 96100, Italy |
Completed | A.O.U. Ist.Ospitalieri Verona | Verona, 37136, Italy |
Completed | A.O. Sant'Anna-San Sebastiano | Caserta, 81100, Italy |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit).date_rangeTime Frame:5-9 daysenhanced_encryptionnoSafety Issue:
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- Bacteriological outcome during treatmentdate_rangeTime Frame:7-14 daysenhanced_encryptionnoSafety Issue:
- Bacteriological outcome at follow-update_rangeTime Frame:28-42 daysenhanced_encryptionnoSafety Issue:
- Clinical outcome during treatmentdate_rangeTime Frame:7-14 daysenhanced_encryptionnoSafety Issue:
- Clinical outcome at the test-of-cure visitdate_rangeTime Frame:5-9 daysenhanced_encryptionnoSafety Issue:
- Clinical outcome at follow-update_rangeTime Frame:28-42 daysenhanced_encryptionnoSafety Issue:
- Adverse event collectiondate_rangeTime Frame:28-42 daysenhanced_encryptionnoSafety Issue:
Trial design
Trial Type info
InterventionalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
TreatmentThe main reason the clinical trial is being done.
Allocation info
RandomizedAllocation is the way treatments are assigned to the people in the trial.
Blinding info
Double Blind“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
Parallel AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
2A “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.