Rapid Empiric Treatment With Oseltamivir Study (RETOS)
Palabras clave
Abstracto
Descripción
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 study[RETOS]) 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 inclusion/exclusion 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 IDSA/ATS (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 1:1 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.
fechas
| Verificado por última vez: | 09/30/2017 |
| Primero enviado: | 11/22/2010 |
| Inscripción estimada enviada: | 11/22/2010 |
| Publicado por primera vez: | 11/24/2010 |
| Última actualización enviada: | 10/02/2017 |
| Última actualización publicada: | 11/05/2017 |
| Fecha de los primeros resultados enviados: | 08/06/2017 |
| Fecha de los primeros resultados de CC enviados: | 08/06/2017 |
| Fecha de los primeros resultados publicados: | 09/05/2017 |
| Fecha de inicio real del estudio: | 10/31/2010 |
| Fecha estimada de finalización primaria: | 04/30/2016 |
| Fecha estimada de finalización del estudio: | 04/30/2016 |
Condición o enfermedad
Intervención / tratamiento
Drug: Oseltamirvir
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Experimental: Oseltamirvir These patients will receive early oseltamivir plus current, standard empiric antibacterial therapy. | Drug: Oseltamirvir These patients will receive early (within 8-12 hours of admission, no later than 24 hours after admission) oseltamivir plus current, standard empiric antibacterial therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP (2). Anti-influenza therapy will be given using oseltamivir at a dose of 75 mg twice daily. The oseltamivir dose will be adjusted in patients with renal insufficiency according to the package insert. Duration of antiviral therapy will be for a minimum of 5 days for patients with evidence of early clinical improvement and prolonged depending on clinical stability |
| No Intervention: Standard of care These patients will be treated with the current, standard care, including currently recommended antibiotics or antiviral therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP and ACIP antiviral use guidelines for hospitalized patients with confirmed of suspect influenza, per clinician discretion. In addition these patients with have a NP swab collected for influenza PCR testing and clinical information will be extracted from the medical record. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: For oseltamivir and standard of care groups: - 18 years of age or older - No oseltamivir or zanamivir ordered in hospital admission orders - Meets criteria for acute LRTI - Signed informed consent. Exclusion Criteria: For oseltamivir and standard of care groups: - Oseltamivir or zanamivir ordered in hospital admission orders - Patients hospitalized for the LRTI for more than 24 hours before enrollment into the trial. - Patients with mental conditions who are unlikely to comply with the study protocol and who cannot give informed consent and have no guardian or proxy. - Patients who have had severe allergic reactions such as anaphylaxis or serious skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, or erythema multiforme to any component of oseltamivir (TAMIFLU). - Prisoners |
Salir
Medidas de resultado primarias
1. Number of Participants With Clinical Failure (Failure to Reach Clinical Stability) [7 days]
2. Number of Participants to Transfer to ICU After 24 h [24 h]
3. Number of Participants That Required Re-hospitalization [30 days]
4. Number of Participants That Had Short-term Mortality [30 days]
Medidas de resultado secundarias
1. Days to Reach Clinical Stability [30 days]
2. Length of Hospital Stay [through study completion, up to 30 days]
3. Number of Participants With Hospital Mortality. [through study completion, up to 30 days]
