None listed
Conditions
Interventions
Group 1 Type of group
Faropenem daloxato: one 300 mg tablet twice a day for 10 days
Group name:Group 2 Type of group
Amoxicillin-davulanic acid: one 500/125 mg tablet
three times a day for 10 days.
Sponsors
BAYER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Male or female patients 18 years of age or older. • Patients with signs and symptoms of bacterial pneumonia likely to be treated appropriately with oral antibacterial therapy. • In order for them to be classified as patients with community-acquired bacterial pneumonia, these patients must show signs of A, B, and C: A: At least one of the following elements must be presented: - Fever (eg, rectal value / tympanic membrane> 38.5 ° C or oral / axillary / cutaneous temperature value> 38.0C) - Hyperleukocytosis with leukocyte count (RGB)> 10,000 / mm ^ and / or> 15% immature neutrophils (non-segmented) or leukopenia with RGB count 20 aspirations / min.) - Pleuritic chest pain - Auscultatory detection as rales indicating pulmonary consolidation. C. Radiological tests of infiltrate (s) indicating pneumonia; • Patients with community-acquired pneumonia considered clinically appropriate for treatment in outpatient settings, as well as any of the following elements: - Patients currently hospitalized if hospitalization <48 hours. - Patients for whom severe hospitalization is expected. - Patients who are in long-term care facilities and do not require special medical treatment. • Women of childbearing age, including women in the postmenopausal period for less than a year who use reliable contraceptive methods during exposure to the study drug. • Patients who have the ability and intention to give written consent.
Exclusion criteria
Exclusion criteria: • Patients with a history of hypersensitivity to study drugs or related substances. • Women who are pregnant or breastfeeding. • Patients with a history of liver injury due to the administration of beta-lactams. • Patients who may suffer from aspiration pneumonia. • Patients requiring any concomitant inhaled or systemic antibiotic. • Patients requiring mechanical ventilation. • Patients who have received a systemic antibacterial agent for more than 24 hours during the 7 days prior to inclusion in the study. • Patients with concurrent and medically active pulmonary disease that may affect the outcome of the trial (eg, active pulmonary tuberculosis, lung cancer, lung abscesses, cystic fibrosis, known bronchiectasis, pleural empyema or collagen vascular diseases affecting the lungs) . • Patients with known neutropenia (absolute neutrophil count 3.0 mg / dl [> 265 umol / l]). • Patients with a known liver disease or with significant hepatic impairment (ie, ALT and / or ASI and / or total bilirubin> 3 times the upper limit of the normal level). • Patients with severe heart failure (ie class IV NYHA classification). • Patients with a serious life-threatening disease whose life expectancy is less than 2 months. • Patients previously included in this or any other study with faropenem daloxato. • Patients who have taken any investigational drug in the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Percentage of patients who achieve a clinical cure at the check-up visit. Measure:Clinical response at the check-up visit Timepoints:7 to 14 days after the last test dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Percentage of patients who achieve a clinical cure Measure:Clinical response on the day of treatment 3-5 Timepoints:Days 3-5 ; Outcome name:Culture results Measure:Bacteriological response in the check-up visit Timepoints:7 to 14 days after the last test dose ; Outcome name:Percentage of patients who achieve a clinical cure Measure:Clinical response at the check-up visit in patients with bacteriologically proven pneumonia Timepoints:7 to 14 days after the last test dose ; Outcome name:Percentage of patients who achieve a clinical cure Measure:Clinical response at the check-up visit in patients with pneumococcal pneumonia tested bacteriologically Timepoints:7 to 14 days after the last test dose ; Outcome name:Percentage of patients who achieve a clinical cure Measure:Clinical response in the check-up visit in patients with proven bacterial pneumonia Timepoints:7 to 14 days after the last test dose ; Outcome name:Percentage of patients who achieve a clinical cure Measure:Clinical response at the follow-up visit (28-35 days after the last test dose) Timepoints:28-35 days after the last test dose ; Outcome name:Culture results Measure:Bacteriological response in the follow-up visit Timepoints:28-35 days after the last test dose ; Outcome name:CAP symptom questionnaire Measure:Evolution of symptoms associated with CAP according to the CAP symptom questionnaire Timepoints:At the end of the treatment | — |
Outcome results
None listed