Study with Randomized Group Assignment, Double Blind, Double-Simulation, Multicenter, Parallel Groups to Compare the Efficacy, Safety and Tolerability of Intravenous Administration of Gemifloxacin Followed by Administration of Gemifloxacin Orally Against Intravenous Administration of Ceftriaxone Followed by Administration of Levofloxacin Orally, in the Treatment of Nosocomial Pneumonia (NN) in Adults with Low Risk of Pseudomonas Aeruginosa Infectio
- Conditions
- -B965 Pseudomonas (aeruginosa) as the cause of diseases classified to other chaptersPseudomonas (aeruginosa) as the cause of diseases classified to other chaptersB965
- Registration Number
- PER-050-00
- Lead Sponsor
- SMITHKLINE BEECHAM INTERAMERICAN,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 0
• Men or women> 18 years of age.
• Grant, by the patient or his authorized legal representative, of informed consent, in writing and dated, to participate in the study.
• Patients hospitalized for> 48 hours and patients readmitted to the hospital less than 7 days after discharge from a previous hospitalization of> 3 days duration with clinical diagnosis of pneumonia of recent onset.
• Patients with non-severe pneumonia, without risk factors to suffer from infection by pathogens resistant to multiple antimicrobial agents (see definitions below), and with onset of symptoms at any time during hospitalization or patients with severe pneumonia, without factors of risk to suffer infection by pathogens carriers of resistance to multiple antimicrobial agents and with onset of symptoms> 2 days and <5 days after hospitalization.
• Patients who have been in the intensive care unit for> 5 days.
• Patients who have maintained mechanical ventilation for ^ 5 days.
• Patients who have been non-ambulatory residents in an Institution for Long-Term Care.
• Patients who have completed a course of antibiotic treatment within 2 weeks prior to the screening (except for those patients who have not received more than 24 hours of antibiotic treatment within 48 hours prior to receiving treatment with the medication in study).
• Patients with known bronchial obstruction or history of postobstructive pneumonia.
• Patients with cystic fibrosis, suspicion or confirmation of Pneumocystis carinii pneumonia, active, known or suspected tuberculosis, bronchiectasis (with clinical signs and symptoms), or active lung malignancies.
• Patients with a history of gastrointestinal surgery (during the current hospitalization or a previous hospitalization), in which the procedure involved the opening of the gastrointestinal tract and aspiration confirmed by witnesses.
• Patients with known or suspected risk of P. aeruginosa infection.
• Patients with APACHE score n <8 or> 25 (See Appendix G) [33].
• Patients with persistent shock status, defined as the identification of systolic blood pressure <90mmHg for> 2 hours despite adequate resuscitation with fluids, with evidence of hypoperfusion or need for sympathetic mimetic agents to maintain blood pressure.
• Patients with any other condition that threatens imminently to life, or serious or unstable, underlying.
• Patients with known or suspected severe hepatic impairment, or with known or suspected concentrations of ALT, AST, or alkaline phosphatase greater than 3 times the upper limit of the reference range, or total bilirubin concentration greater than 1.5 times the upper limit of the normal range.
• Patients with an estimate of creatinine clearance that is known or suspected <50mL / min,
• Patients with neutropenia, defined as im absolute neutrophil count <1000 / mm3.
• Patients known to be HIV positive with a CD4 lymphocyte count <200 cells / mm3.
• Patients with a history of hemolytic crisis or known G6PD deficiency.
• Patients with acquired or congenital immunodeficiency, including those who are receiving immunosuppressive treatment or who are scheduled to receive systemic treatment with medications known to have an immunosuppressant potential (including chronic treatment with prednisone at doses> 10mg per day, or its equivalent).
• Patients with known or suspected hypersensitivity to quinolones, cephalosporins or penicillin.
• Patients with a history of tendonitis during treatment with fluoroquinolones.
• Patients who are currently receiving treatment for epilepsy, seizures or myasthenia gravis.
• Patients who are receiving, at the present time, treatment with probenecid.
• Treatment with any medication, device or experimental vaccine within the previous 30 days, or 5 half-lives (whichever is longer), prior to entering the study.
• Patients who are probably not able to swallow or tolerate the use of medications orally, at any time.
• Patients in whom there is evidence of active abuse of alcohol or illicit drugs, including prescription medications.
• Patients unable or unwilling to comply with the procedures described in the protocol.
• Patients who have been previously rejected in this or any other study that involves the use of gemifloxa
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The investigator will compare the signs and symptoms of nosocomial pneumonia (eg, fever or hypothermia, cough, dyspnea, tachypnea, pleuritic chest pain, auscultatory findings, sputum characteristics, chills, and also oxygen saturation (measurement of arterial blood gases or oximetry). pulse) and the leukocyte count), recorded during the Screening Visit, prior to the start of treatment, with the signs / symptoms of nosocomial pneumonia recorded at the End of Treatment Visit to evaluate the patients clinical response to the study medication<br>Measure:Clinical Efficacy<br>Timepoints:At the beginning and end of the treatment.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:The clinical and radiological response will be assessed based on information prior to the disclosure of the treatment assignment.<br>Measure:Radiological Response<br>Timepoints:Once the patient has concluded his participation in the study<br>;<br>Outcome name:Bacteriological outcomes and responses to the study drug will be assessed based on information prior to the disclosure of treatment allocation<br>Measure:Bacteriological Response<br>Timepoints:Once the patient has completed his participation in the study<br>