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| Name | Class |
|---|---|
| Fundacion Clinic per a la Recerca Biomédica | OTHER |
| Miquel Ferrer - Investigator Coordinator | UNKNOWN |
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Non-inferiority, multicenter, prospective double-blind, randomized clinical trial of two parallel groups. The randomization between the 2 study groups will be carried out according to a scheme generated by a computer program, in blocks of 6 and stratified by centers. The antibiotic treatment will be evaluated during 5 days compared to the usual antibiotic treatment for more than 7 days in patients with community-acquired pneumonia with a Pneumonia Severity Index IV-V severity score who present an adequate response in the first 4 days of hospital antibiotic treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxifloxacin | Active Comparator | Active treatment to patients treated during the 5 previous days. |
|
| Placebo | Experimental | Placebo treatment to patients treated during the 5 previous days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxifloxacin | Drug | 400 mg / day once a day oral treatment during 3 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of treatment failure | Treatment failure is defined as the appearance of any of the following manifestations: death from any cause, hospital readmission for any cause or restart of antibiotic treatment for any reason. | during the 30 days after the day of hospital admission |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | up to 2 years | |
| Antibiotic-free days | Antibiotic-free days are defined as the number of days alive and free of antibiotics | Up to 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adrian Ceccato, MSD | Contact | +34.93.227.54.00 | aceccato@clinic.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Mataró | Recruiting | Mataró | Barcelona | 08304 | Spain |
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Double blind treatment
| Placebo | Drug | once a day oral treatment during 3 days. |
|
| Proportion of adverse events | Up to 28 days |
| Proportion of serious adverse events | Up to 28 days |
| Hospital Galdakao-Usansolo | Recruiting | Galdakao | Bizkaia | 48960 | Spain |
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| Hospital Universitario La Fe | Recruiting | Valencia | Valencia | 46026 | Spain |
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| Hospital Clínic i Provincial de Barcelona | Recruiting | Barcelona | 08036 | Spain |
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| Hospital Universitario Virgen de Valme | Recruiting | Seville | 41001 | Spain |
|
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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