Ignite Creation Date:
2024-05-05 @ 11:04 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01248715
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2010-11-23
Brief Title:
Rapid Empiric Treatment With Oseltamivir Study RETOS
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
Title Effectiveness of Empiric Antiviral Treatment for Hospitalized Community Acquired Pneumonia During the Influenza Season U18
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RETOS
Brief Summary:
Current guidelines recommend early initiation of empiric antibiotic therapy to cover typical and atypical bacteria that may cause community-acquired pneumonia CAP Influenza antiviral therapy in patients with suspected or confirmed influenza However many clinicians do not suspect influenza among patients with CAP or other acute lower respiratory tract illness LRTI and often do not test for influenza Additionally results from currently available diagnostic tests for influenza may be delayed and several tests have low sensitivity and will give false negative results Thus anti-influenza treatment for patients with hospitalized influenza CAP and LRTI is frequently initiated late if at all There is an association between delayed time to administration of empiric antibiotic therapy with increased clinical failure and mortality As a result empiric antibiotic therapy for patients with suspect CAP is begun within 4 - 6 hours of hospitalization This has recently been demonstrated for delayed antiviral treatment as well We hypothesize that as happens with early empiric antibiotics for bacterial CAP a standardized approach of adding early empiric anti-influenza therapy during the influenza season to hospitalized patients with suspect CAP and LRTI will improve clinical outcomes of patients with influenza associated CAP and LRTI
To test our hypothesis we plan a prospective randomized multicenter clinical trial of hospitalized patients with acute LRTI including suspect CAP during If early anti-influenza medications were not included on the patients admission orders patients will be randomized to standard care including empiric antibacterial therapy as recommended by ATSIDSA guidelines plus standard influenza diagnostics and treatment Standard of care versus early initiation of empiric antiinfluenza therapy plus standard care eg empiric antibacterial oseltamivir group The primary study outcome will be development of clinical failure and selected clinical outcomes during the 30 days after enrollment Other clinical outcomes that will be compared between study groups include time to clinical stability duration of hospitalization development of cardiovascular events re-hospitalization short-term mortality 30 days and long-term mortality 1 year The secondary study outcome will be the cost-effectiveness of the intervention
To test our hypothesis we plan a prospective randomized multicenter clinical trial of hospitalized patients with acute LRTI including suspect CAP during If early anti-influenza medications were not included on the patients admission orders patients will be randomized to standard care including empiric antibacterial therapy as recommended by ATSIDSA guidelines plus standard influenza diagnostics and treatment Standard of care versus early initiation of empiric antiinfluenza therapy plus standard care eg empiric antibacterial oseltamivir group The primary study outcome will be development of clinical failure and selected clinical outcomes during the 30 days after enrollment Other clinical outcomes that will be compared between study groups include time to clinical stability duration of hospitalization development of cardiovascular events re-hospitalization short-term mortality 30 days and long-term mortality 1 year The secondary study outcome will be the cost-effectiveness of the intervention
Detailed Description:
This will be both a prospective randomized unblinded clinical study of hospitalized patients with acute LRTI admitted in one of four institutions in Louisville KY rapid empiric treatment with oseltamivir studyRETOS and a prospective observation study to describe influenza LRTI Flu LRTI study All hospitalized patients with acute LRTI will be invited to participate in one of the arms of study If the admitting clinician does not order oseltamivir or zanamivir at the time of hospital admission the patient is eligible for randomization into Group A standard clinical care including empiric antibiotics and anti-influenza drugs at the clinician discretion or Group B oseltamivir administered to the patient within 24 hours of admission ideally within 8-12 hours of admission plus empiric antibiotics
Patients will be enrolled from one of four hospitals the University of Louisville Hospital Veterans Affairs Medical Center of Louisville Norton Hospital of Louisville and Jewish Hospital of Louisville Eligible patients will be identified primarily in the Emergency Departments of all four hospitals and evaluated for inclusionexclusion criteria after hospital admission orders are written Patients will be enrolled only during the influenza season For this study the influenza season is defined as December 1st until May 1st unless surveillance data suggests that influenza viruses are circulating earlier or have stopped circulating
For all three study groups diagnosis of influenza will be based on nucleic acid amplification through polymerase chain reaction PCR At the time of enrollment into the study a nasopharyngeal swab will be obtained for PCR The University of Louisville Infectious Diseases Reference Laboratory has extensive experience using molecular techniques for the diagnosis of respiratory pathogens and will test batched specimens at monthly intervals In addition we will collect the results from tests done for routine care and bacterial or virus isolates identified during routine care for further characterization
The management of patients in Group A and Group B will be different only in regard to early empiric anti-influenza therapy All other aspects of the management of these patients will be in compliance with national guideline recommendations from IDSAATS 2 Patients in Group A may have antiviral therapy started later in hospitalization or not treated at all The study will not interfere with Group A patient care
A 11 randomization ratio within the two study arms is planned for EOS A pre-defined randomization chart will be designed in order to have the randomization process Internet-based The randomization table will be accessible by the project manager as a back up in the event that any problem occurs with the Internet or the computerized system
We will attempt to begin oseltamivir within 8 - 12 hours after hospital admission and no later than 24 hours The study nurse will facilitate receipt of early oseltamivir treatment for the consented patient in collaboration with the hospital pharmacies The time of oseltamivir administration will be recorded for all enrolled patients
Patients will be enrolled from one of four hospitals the University of Louisville Hospital Veterans Affairs Medical Center of Louisville Norton Hospital of Louisville and Jewish Hospital of Louisville Eligible patients will be identified primarily in the Emergency Departments of all four hospitals and evaluated for inclusionexclusion criteria after hospital admission orders are written Patients will be enrolled only during the influenza season For this study the influenza season is defined as December 1st until May 1st unless surveillance data suggests that influenza viruses are circulating earlier or have stopped circulating
For all three study groups diagnosis of influenza will be based on nucleic acid amplification through polymerase chain reaction PCR At the time of enrollment into the study a nasopharyngeal swab will be obtained for PCR The University of Louisville Infectious Diseases Reference Laboratory has extensive experience using molecular techniques for the diagnosis of respiratory pathogens and will test batched specimens at monthly intervals In addition we will collect the results from tests done for routine care and bacterial or virus isolates identified during routine care for further characterization
The management of patients in Group A and Group B will be different only in regard to early empiric anti-influenza therapy All other aspects of the management of these patients will be in compliance with national guideline recommendations from IDSAATS 2 Patients in Group A may have antiviral therapy started later in hospitalization or not treated at all The study will not interfere with Group A patient care
A 11 randomization ratio within the two study arms is planned for EOS A pre-defined randomization chart will be designed in order to have the randomization process Internet-based The randomization table will be accessible by the project manager as a back up in the event that any problem occurs with the Internet or the computerized system
We will attempt to begin oseltamivir within 8 - 12 hours after hospital admission and no later than 24 hours The study nurse will facilitate receipt of early oseltamivir treatment for the consented patient in collaboration with the hospital pharmacies The time of oseltamivir administration will be recorded for all enrolled patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None