Negative Beta Glucan in ICU Patients
Palabras clave
Abstracto
Descripción
Entry criteria are: In the ICU for >2 days AND systemic antibiotics >2 days OR central venous catheter for >days AND at least two of the following: total parenteral nutrition, dialysis, surgery, pancreatitis, receipt of corticosteroids, receipt of other immunosuppressive agents. In addition, patients must have a clinical sign of infection (either one of the following): fever, hypothermia, hypotension, unexplained acidosis, or unexplained elevation in C-reactive protein.
Eligible patients will be enrolled after signing an informed consent and will have blood obtained for culture and determination of 1,3 beta-D-glucan serum levels for 3 days, and will start anidulafungin IV.
If all tests are negative, anidulafungin will be discontinued on day 4. If 1,3 beta-D-glucan is positive (>80 pg/ml) and / or blood cultures are positive for Candida species, anidulafungin will be continued for >14 days.
fechas
| Verificado por última vez: | 03/31/2019 |
| Primero enviado: | 11/19/2012 |
| Inscripción estimada enviada: | 11/25/2012 |
| Publicado por primera vez: | 11/26/2012 |
| Última actualización enviada: | 04/17/2019 |
| Última actualización publicada: | 07/07/2019 |
| Fecha de los primeros resultados enviados: | 11/29/2015 |
| Fecha de los primeros resultados de CC enviados: | 04/17/2019 |
| Fecha de los primeros resultados publicados: | 07/07/2019 |
| Fecha de inicio real del estudio: | 10/31/2012 |
| Fecha estimada de finalización primaria: | 11/30/2013 |
| Fecha estimada de finalización del estudio: | 11/30/2013 |
Condición o enfermedad
Intervención / tratamiento
Drug: Anidulafungin
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Experimental: Anidulafungin Patients at risk will receive therapy with anidulafungin | Drug: Anidulafungin Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - In the ICU for >2 days AND - Systemic antibiotics on days 1-3 of ICU OR - Central venous catheter on days 1-3 of ICU - AND at least 2 of: - Total parenteral nutrition on days 1-3 of ICU - Any dialysis on days 1-3 of ICU - Major surgery in the 7 days before admission in the ICU - Pancreatitis in the 7 days before admission in the ICU - Use of corticosteroids for at least 3 days in the 7 days before admission - Use of other immunosuppressive agents in the 7 days before admission in the ICU - In addition, the patient must have at least one of the following: - Fever (axillary temperature >37.5 oC) - Hypothermia (axillary temperature <35 oC) - Hypotension - Unexplained acidosis - Unexplained elevation in C-reactive protein Exclusion Criteria: - Antifungal for >3 days - Allergy to an echinocandin |
Salir
Medidas de resultado primarias
1. Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin [30 days]
