None listed
Conditions
Interventions
Group 1 Type of group
Cidecin IV (daptomycin) 4 mg / kg, once a day for a
minimum of 5 days to a maximum of 14 days
Group name:Group 2 Type of group
Rocephin® IV (ceftriaxone) 2 g, once a day for a
minimum of 5 days to a maximum of 14 days
Sponsors
UNIVERSIDAD PERUANA CAYETANO HEREDIA,
Eligibility
Inclusion criteria
Inclusion criteria: • Provide dated and signed Informed Consent. • Adults 18 years of age or older, of any sex and race, weighing up to 150 kg. Female patients of childbearing age SHOULD NOT be pregnant (confirmed by negative serum pregnancy test), nor breastfeeding, and must agree to use reliable measures of birth control during and at least 30 days after treatment with / the medication (s) in the study. • Have a new pulmonary infiltrate on the chest radiograph. • Show at least two of the following clinical symptoms of pneumonia in the background or physical examination: Cough, production of purulent sputum or change in the character of the sputum, auscultatory findings in the pulmonary examination of rales and / or evidence of pulmonary consolidation (opacity to percussion, bronchial rales or egophony), dyspnea or tachypnea, Fever, defined as body temperature> 38 ° C (I00.4®F) taken orally; > 38.5®C (101.2®F) tympanic; or; > 39.0 ®C (102.2®F) rectal or hypothermia, defined as core body temperature of 10,000 / mm3); or> 15% immature neutrophils (bands), regardless of the total peripheral white blood cell count; or leukopenia with total white blood cell count <4500 / mm3, hypoxemia with P02 <60 mmHg (in ambient air) or saturation of 02 <90% in ambient air • Pneumonia that requires hospitalization intravenous treatment for at least 5 days, • Agree to participate in this study and complete all follow-up evaluations
Exclusion criteria
Exclusion criteria: • Patients with Grade V pneumonia (based on Fine Score, Appendix 8). • Patient in respiratory failure or incipient respiratory failure if the patient is not a candidate for mechanical ventilation (for any reason) • Any of the following lung conditions leading to a misinterpretation of the results of the study: Cystic fibrosis, Primary lung cancer or other metastatic malignancy to the lungs, known bronchial obstruction or history of post-obstructive pneumonia, known active tuberculosis is suspected • Severe shock (systolic blood pressure 30 minutes, uncorrected with bolus fluids). • Clinical evidence of bacterial meningitis (based on lumbar puncture results), • Severe renal insufficiency (calculated creatinine clearance 24 hours (or one day of dosing) within 72 hours of enrollment, or prior treatment with any investigational medication (including experimental biological agents) during the past 30 days, or previous treatment with daptomycin. • Patients who must continue treatment with an HMG-CoA reductase inhibitor (eg, simvastatin, lovastatin, etc.) during the study treatment period. • It is anticipated that a second systemic antibiotic not allowed by the protocol will be needed. • Induction chemotherapy within 2 weeks prior to enrollment (or exogenous treatments that are known to result in PMN counts 14 days from health care institutions or hospital, with an initial hospitalization of> 3 days duration) • Clinical suspicion of Legionella pneumonia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:As determined by the resolution or improvement of clinically significant signs and symptoms of pneumonia in the Cure Test Visit. Measure:Patients Clinical Response Timepoints:In the Cure Test Visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:As determined by the microbiological eradication rate in the Cure Test Visit. Measure:Microbiologicasl response Timepoints:I8n the Cure Test Visit. ; Outcome name:Clinical test and result of cultures Measure:Combined clinical / microbiological response in the Cure Test Visit. Timepoints:In the Cure Test Visit. ; Outcome name:Relapse and recurrence rates Measure:Relapse and recurrence rates in the follow-up visit. Timepoints:In the follow-up visit. ; Outcome name:Culture results Measure:Microbiological response based on pathogens. Timepoints:After treatment | — |
Outcome results
None listed