check_circleStudy Completed
Infectious Diseases
Bayer Identifier:
12670
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A study to assess efficacy and safety of IV/PO moxifloxacin in the treatment of cSSSIs
Trial purpose
The purpose of this study is to assess if a therapy with intravenous and oral moxifloxacin is as effective as a therapy with intravenous and oral amoxicilline/clavulanate in the treatment of complicated skin and skin structure infection.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
16Trial Dates
November 2008 - October 2009Phase
Phase 3Could I Receive a placebo
NoProducts
Avelox (Moxifloxacin hydrochloride, BAY12-8039)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | ASL TO/2 - Piemonte | Torino, 10149, Italy |
Terminated | A.O. Osp Circolo e Fond.Macchi | Varese, 21100, Italy |
Terminated | A.O. Carlo Poma | Mantova, 46100, Italy |
Terminated | A.O. Ospedali Riuniti Bergamo | Bergamo, 24128, Italy |
Terminated | A.O.U. Policlinico Consorziale | Bari, 70124, Italy |
Completed | A.O.U. Careggi | Firenze, 50139, Italy |
Terminated | A.O.U. Ospedali Riuniti Foggia | Foggia, 71100, Italy |
Terminated | A.O.U. di Bologna - Policlinico S.Orsola-Malpighi | Bologna, 40138, Italy |
Completed | IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca Cancro | Genova, 16132, Italy |
Terminated | A.O. Spedali Civili | Brescia, 25123, Italy |
Terminated | A.O. di Reggio Emilia | Reggio Emilia, 42100, Italy |
Terminated | A.O.U. Santa Maria Misericordia UD | Udine, 33100, Italy |
Terminated | A.O.U. Integrata Verona | Verona, 37126, Italy |
Terminated | A.O. di Padova | Padova, 35128, Italy |
Terminated | A.O.U. di Ferrara | Ferrara, 44100, Italy |
Completed | A.O. Domenico Cotugno | Napoli, 80131, Italy |
Completed | IRCCS Ist Spallanzani | Roma, 00149, Italy |
Terminated | AUSL 10 Firenze - Toscana | Bagno di Ripoli, 50100, Italy |
Terminated | Università Cattolica del Sacro Cuore | Roma, 00168, Italy |
Terminated | A.O. di Perugia | Perugia, 06122, Italy |
Terminated | A.O. Papardo di Messina | Messina, 98158, Italy |
Completed | AUSL Rimini - Emilia Romagna | Rimini, 47900, Italy |
Primary Outcome
- Clinical response up to 14-21 days after the completion of study drug therapy (Test-of-Cure visit [TOC]).date_rangeTime Frame:Test-of-Cure visit [TOC].enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Clinical response assessed by the investigator on treatment Day 3-5date_rangeTime Frame:Day 3-5enhanced_encryptionnoSafety Issue:
- Clinical response assessed by the investigator at the end-of-therapy (EOT).date_rangeTime Frame:At the end-of-therapy (EOT)enhanced_encryptionnoSafety Issue:
- Time to switch from oral to IV therapydate_rangeTime Frame:Day of switch from oral to IV therapyenhanced_encryptionnoSafety Issue:
- Bacteriological response (for microbiologically valid population) at the EOT and TOCdate_rangeTime Frame:At the end-of-therapy (EOT), Test-of-Cure visit [TOC].enhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2Additional Information
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