Community Acquired Bacterial Pneumonia with criteria of seriousness and great likelihood of polymicrobial or gram-negative microbial etiology.
Conditions
Interventions
Trade Name: INVANZ TM
Product Name: INVANZ
Product Code: L-000749345, MK-0826
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Ertapenem sodium
Current Sponsor code: MK-0826
Concentratio
Sponsors
Merck Sharp and Dohme de España
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Patient is at least 65 years old. b. Patient has a clinically suspected and/or bacteriologically documented CAP with great likelihood of polymicrobial or gram-negative microbial etiology, according to the following diagnostic criteria: c. Patient’s infection is characterized as serious (requiring hospitalization or outpatient parenteral antibiotic treatment). d. Patient’s infection is known or thought to be caused by microorganisms susceptible to the parenteral study antibiotics, in the opinion of the investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a. Infection(s) due to organisms known to be resistant to ertapenem or levofloxacin. b. The need for concomitant systemic antimicrobials in addition to the study antibiotics. c. Systemic antibiotic therapy for = 24 hours known to be effective against the presumed or documented etiologic pathogen(s) d. Patients with a prior history of tuberculosis and who: (1) are currently on therapy, or (2) have active untreated tuberculosis, or (3) have a positive acid fast bacilli (AFB) smear. e. Patients with presumed Legionellosis should not be enrolled in the study (testing of urine and/or sputum for Legionellosis will be required per protocol prior to study entry only if patient is in a setting where an outbreak of Legionella infection is suspected). f. History of serious allergy, hypersensitivity, or any adverse reaction to any quinolone, carbapenem, or beta-lactam antibiotic. g. Patients with ventilator-associated pneumonia h. Sepsis syndrome with acute hemodynamic instability or adult respiratory distress syndrome. i. Chronic immunosuppressive therapy, including use of high dose corticosteroids j. Patients with cystic fibrosis. k. Neutropenia with absolute neutrophil count (ANC) ? 1000/mm3. l. Empyema m. Patients with known bronchial obstruction, a history of postobstructive pneumonia, or other structural lung diseases associated with larger airway obstruction (e.g., bronchiectasis). n. Patients with primary lung cancer or another malignancy metastatic to the lungs. o. Documented HIV infection with a CD4 cell count of = 200 cells/mm3. p. Signs of meningitis, such as nuchal rigidity, papilledema, or other findings of meningitis. q. Laboratory abnormalities which affect over the security level from one or more of the following parameters: Hematocrit, platelet count, coagulation test, ALT, AST, bilirrubin, alkaline phosphatase, hemoglobin and calculated creatinine clearance. r. s. Patients requiring peritoneal dialysis or hemodialysis, or hemofiltration t. Patients with acute hepatic failure or acute decompensation of chronic hepatic failure u. Patients with a history of epilepsy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: a. In elderly patients (= 65 years old) who are clinically evaluable, to assess the efficacy of ertapenem with respect to high-dose levofloxacin measured as the proportion of patients achieving a favorable clinical response (“cure”) at (a) DOT, and (b) 2 weeks post-DOT (TOC). b. Using serial rectal swabs obtained from patients enrolled in the study who are being treated for CAP, to assess the impact of therapy with ertapenem versus high-dose levofloxacin on the emergence of resistant gram-negative microorganisms in the bowel flora. ;Secondary Objective: a. In elderly patients (= 65 years old) who are microbiologically evaluable, to assess the efficacy of ertapenem with respect to high-dose levofloxacin measured as the proportion of patients achieving microbiological eradication at (a) DOT, and (b) 2 weeks post-DOT. b. In elderly patients (= 65 years old) who received study therapy for = 1 dose, to assess the safety of ertapenem with respect to high-dose levofloxacin measured as the proportion of patients with one or more drug-related serious adverse experiences (SAEs). c. In elderly patients (= 65 years old) who received study therapy for = 1 dose, to assess the safety of ertapenem with respect to high-dose levofloxacin measured as the proportion of patients with one or more drug-related adverse experiences (AEs). ;Primary end point(s): 1. The proportion of patients within each treatment group who have a favorable clinical response (“cure”) at (a) DOT, and (b) 2 weeks post-DOT (TOC). 2. The proportion of patients within each treatment group with resistant gram-negative microorganisms isolated from serial rectal swabs at (a) baseline, (b) DOT, and (c) 2 weeks post-DOT. | — |
Countries
Spain
Outcome results
None listed