Optimizing Dosing Regimen of Piperacillin/Tazobactam, Prolonged Infusion vs. Regular Infusion, Every 6 Hours, for Nosocomial Pneumonia in ICU Caused by Susceptible Pathogens With Higher MIC
C Group
+ E Group
Infección Cruzada+7
+ Enfermedad Iatrogénica
+ Infecciones
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 2012
Fecha en la que se inscribió al primer participante.Enrolled patients will be randomized into therapeutic or controlled group. Controlled group will receive piperacillin/tazobactam of 4.5g Q6h, intermittent infusion for 30 minutes. Therapy group will receive piperacillin/tazobactam of 4.5g Q6h, prolonged infusion for 4 hours. The duration is 7-14 days. Two sets of blood cultures (for aerobic and anaerobic culture) were obtained before the study and post-treatment period if first blood culture is positive. Cultures from the lower respiratory tract infection were obtained before (within 48 h) the study and on the last day of therapy. The lower respiratory tract specimens obtained either by endotracheal aspiration, bronchoalveolar lavage (BAL), a protected brush procedure (PBP) or as sputum were required to show > 25 polymorphonuclear cells and < 10 squamous epithelial cells per field (at 100× magnification). The plasma concentration of piperacillin and tazobactam will be determined by LC/MS/MS method. The QC samples will also be analyzed simultaneously with each run for the method stability testing, according to the laboratory standard procedure.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 50 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 70 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: Male or female, aged 18 to 70 years old. Inpatients with nosocomial pneumonia or bacteremia. i. Diagnosis of nosocomial pneumonia Chest radiographic infiltrate that is new or progressive. At least two or more of the following clinical findings suggesting infection. New onset of fever, oral temperature T>38.3℃ or T<36℃ Purulent sputum WBC > 12×10^9/L or <4×10^9/L, or band form >10% PaO2/FIO2<240mmHg ii. Diagnosis of bacteremia: Positive blood culture and the isolated bacterial strain are considered to be infection cause. Patients are infected by piperacillin-tazobactam susceptible pathogen with MIC=4, 8 or 16mg/L. Exclusion Criteria: The patients who received systematic antibacterial treatment more than 48 hours before enrollment and have clinical response. Severe pyemia with hypotension or/and evidences of failure of organic function (shock: systolic pressure < 90mmHg or diastolic pressure < 60mmHg, requiring more than 4 hours of administration of vasopressor(s);renal impairment: urine volume < 20 ml∕h or < 80 ml∕4h after excluded any other potentials, acute renal failure need dialysis, CLcr<40 mL/min). Documented infection caused by pathogens beyond the antibacterial spectrum of piperacillin/tazobactam. Previously diagnosed condition which tend to mimic or complicate the course and evaluation of the infectious process, e.g. bronchial obstruction, obstructive pneumonia, activate pulmonary malignancy, pulmonary abscess, empyema and active tuberculosis, which might interfere the course of the infectious disease and evaluation of the disease. History of allergy to penicillins. Pregnancy or breast-feeding women. Any conditions investigator considered might increase the risk of patients or interfere study results.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 2 ubicaciones
TianjinCIH
Tianjin, China