A Phase II, prospective, randomized, double-blind, active-controlled, parallel group, multi-center 'proof of concept' trial in adult patients with community-acquired pneumonia requiring hospitalization without evidence of Legionella

F.Hoffmann-La Roche Ltd0 sites300 target enrollmentMay 30, 2005

Overview

No summary available.

Registry

who.int

Start Date

May 30, 2005

End Date

August 24, 2006

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Patients will qualify to participate in this study if they meet all of the following:
•1\. Are male or female patients greater than or equal to 18 years of age that require hospitalization with community\-acquired pneumonia or develops pneumonia within 48 hours of hospitalization for another condition.
•2\. Have fever defined as body temperature \> 38\.0°C (100\.4°F) taken orally; or \> 38\.5°C (101\.2°F) tympanically; OR have hypothermia, defined as rectal or core body
•temperature \< 36°C (96\.8°F).
•3\. Have a new or increased cough productive of purulent sputum for culture and
•susceptibility testing.
•4\. Have either pleuritic chest pain, dyspnea, or tachypnea.
•5\. Have auscultatory findings consistent with pneumonic consolidation or pneumopathic process consistent with the diagnosis of pneumonia.
•6\. Have chest x\-ray confirmation of infiltrate or lobar consolidation.
•7\. Have obtained respiratory secretion specimen and two blood cultures prior to administration of IV study drug or non\-study short acting third generation cephalosporine. (Respiratory

•Patients will be excluded if they meet any of the following:
•1\. Have a Pneumonia Severity Index \<71 or \>130\.
•2\. Have presented with sustained shock, defined as systolic blood pressure \< 90 mm Hg for \> 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents to maintain blood pressure.
•3\. In the opinion of the investigator, history, physical examination and chest X\-ray
•findings are most consistent with an atypical pneumonia.
•4\. Require endotracheal intubation and ventilation, or in the opinion of the investigator, are expected to require it.
•5\. Are likely to be discharged in less than 3 days.
•6\. Developed pneumonia after more than 48 hours of admission to hospital.
•7\. Have been a resident in a nursing home or extended care facility within 60 days prior to randomization.
•8\. Require hemodialysis, peritoneal dialysis, plasmapheresis or hemoperfusion.