Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001320-12 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess if a therapy with oral and intravenous moxifloxacin is as effective as a therapy with intravenous ceftriaxone + intravenous azithromycin followed by oral amoxicilline/clavulanate and oral clarithromycin in the treatment of community-acquired pneumonia.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avelox (Moxifloxacin, BAY12-8039) | Drug | IV therapy: every 24 hours, patients will be administered a 400 mg moxifloxacin infusion over 60 minutes. Oral therapy: patients will be administered a single moxifloxacin 400 mg tablet, every 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response 20 days after completion of study treatment (Test-of-Cure visit) | 20 days after last dose of study drug (TOC Visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical and bacteriological response on the day of switch from IV to oral therapy | Day of switch from IV to oral therapy | |
| Clinical and bacteriological response on treatment Day 3-5 (if the day of switch is different from Day 3, 4 or 5) | Day 3-5 |
Not provided
Inclusion Criteria:
Hospitalized non-ICU patients (age, >= 18 years)
Clinical signs and symptoms of CAP, with PSI score IV or V
Radiologically confirmed evidence of a new and/or progressive infiltrate(s)
Requirement for initial parenteral therapy
At least 2 of the following conditions:
Written informed consent
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lungro | Cosenza | 87010 | Italy | |||
Not provided
| Label | URL |
|---|---|
| Click here and search for information provided by EMA | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin | Drug | IV therapy: every 24 hours patients will be administered a 2 g ceftriaxone infusion over 30 minutes. Following the infusion with ceftriaxone, patients will be administered a 500 mg azithromycin infusion over 180 minutes.Oral therapy: every 8 hours patients will be administered a 1000 mg amoxicillin/clavulanic acid tablet. Every 12 hours patients will be administered a 500 mg clarithromycin tablet. |
|
| Bacteriological response at TOC | 20 days after last dose of study drug |
| Clinical and bacteriological response at the end of treatment | Day 7-14 after first dose of study drug |
| Mortality attributable to pneumonia at the Test-of-Cure visit | 20 days after last dose of study drug |
| San Cesario di Lecce |
| Lecce |
| 73016 |
| Italy |
| Fossombrone | Pesaro e Urbino | 61034 | Italy |
| Pregiato Di Cava Dei Tirreni | Salerno | 84013 | Italy |
| Vittorio Veneto | Treviso | 31029 | Italy |
| Ascoli Piceno | 63100 | Italy |
| Benevento | 82100 | Italy |
| Brescia | 25123 | Italy |
| Catania | 95122 | Italy |
| Chieti | 66100 | Italy |
| Foggia | 71100 | Italy |
| Lucca | 55100 | Italy |
| Messina | 98125 | Italy |
| Milan | 20142 | Italy |
| Milan | 20157 | Italy |
| Palermo | 90146 | Italy |
| Province of Macerata | 62100 | Italy |
| Roma | 00135 | Italy |
| Roma | 00168 | Italy |
| Roma | 00184 | Italy |
| Sassari | 07100 | Italy |
| Torino | 10154 | Italy |
| Udine | 33100 | Italy |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017714 | Community-Acquired Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| D002443 | Ceftriaxone |
| D017963 | Azithromycin |
| D000658 | Amoxicillin |
| D019818 | Clavulanic Acid |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D002969 | Clavulanic Acids |
Not provided
Not provided