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Angel Estella - One of the best experts on this subject based on the ideXlab platform.
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colistin versus meropenem in the Empirical Treatment of ventilator associated pneumonia magic bullet study an investigator driven open label randomized noninferiority controlled trial
Critical Care, 2019Co-Authors: Jose Miguel Cisneros, Clara Rossofernandez, Cristina Rocaoporto, Gennaro De Pascale, Silvia Jimenezjorge, Esteban Fernandezhinojosa, Dimitrios K Matthaiou, Paula Ramirez, Ramon Ortiz Diazmiguel, Angel EstellaAbstract:Background Colistin is recommended in the Empirical Treatment of ventilator-associated pneumonia (VAP) with a high prevalence of carbapenem-resistant gram-negative bacilli (CR-GNB). However, the efficacy and safety of colistin are not well defined.
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colistin versus meropenem in the Empirical Treatment of ventilator associated pneumonia magic bullet study an investigator driven open label randomized noninferiority controlled trial
Critical Care, 2019Co-Authors: Jose Miguel Cisneros, Clara Rossofernandez, Cristina Rocaoporto, Gennaro De Pascale, Silvia Jimenezjorge, Esteban Fernandezhinojosa, Dimitrios K Matthaiou, Paula Ramirez, Ramon Ortiz Diazmiguel, Angel EstellaAbstract:Colistin is recommended in the Empirical Treatment of ventilator-associated pneumonia (VAP) with a high prevalence of carbapenem-resistant gram-negative bacilli (CR-GNB). However, the efficacy and safety of colistin are not well defined. A multicenter prospective randomized trial conducted in 32 European centers compared the efficacy and safety of colistin (4.5 million unit loading dose followed by a maintenance dose of 3 million units every 8 h) versus meropenem (2 g every 8 h), both in combination with levofloxacin (500 mg every 12 h) for 7–14 days in patients with late VAP. Between May 2012 and October 2015, 232 patients were randomly assigned to the 2 Treatment groups. The primary endpoint was mortality at 28 days after randomization in the microbiologically modified intention-to-treat (mMITT) population. Secondary outcomes included clinical and microbiological cure, renal function at the end of the Treatment, and serious adverse events. The study was interrupted after the interim analysis due to excessive nephrotoxicity in the colistin group; therefore, the sample size was not achieved. A total of 157 (67.7%) patients were included in the mMITT population, 36 of whom (22.9%) had VAP caused by CR-GNB. In the mMITT population, no significant difference in mortality between the colistin group (19/82, 23.2%) and the meropenem group (19/75, 25.3%) was observed, with a risk difference of − 2.16 (− 15.59 to 11.26, p = 0.377); the noninferiority of colistin was not demonstrated due to early termination and limited number of patients infected by carbapenem-resistant pathogens. Colistin plus levofloxacin increased the incidence of renal failure (40/120, 33.3%, versus 21/112, 18.8%; p = 0.012) and renal replacement therapy (11/120, 9.1%, versus 2/112, 1.8%; p = 0.015). This study did not demonstrate the noninferiority of colistin compared with meropenem, both combined with levofloxacin, in terms of efficacy in the Empirical Treatment of late VAP but demonstrated the greater nephrotoxicity of colistin. These findings do not support the Empirical use of colistin for the Treatment of late VAP due to early termination. ClinicalTrials.gov, NCT01292031. Registered 9 February 2011.
Jose Miguel Cisneros - One of the best experts on this subject based on the ideXlab platform.
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colistin versus meropenem in the Empirical Treatment of ventilator associated pneumonia magic bullet study an investigator driven open label randomized noninferiority controlled trial
Critical Care, 2019Co-Authors: Jose Miguel Cisneros, Clara Rossofernandez, Cristina Rocaoporto, Gennaro De Pascale, Silvia Jimenezjorge, Esteban Fernandezhinojosa, Dimitrios K Matthaiou, Paula Ramirez, Ramon Ortiz Diazmiguel, Angel EstellaAbstract:Background Colistin is recommended in the Empirical Treatment of ventilator-associated pneumonia (VAP) with a high prevalence of carbapenem-resistant gram-negative bacilli (CR-GNB). However, the efficacy and safety of colistin are not well defined.
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colistin versus meropenem in the Empirical Treatment of ventilator associated pneumonia magic bullet study an investigator driven open label randomized noninferiority controlled trial
Critical Care, 2019Co-Authors: Jose Miguel Cisneros, Clara Rossofernandez, Cristina Rocaoporto, Gennaro De Pascale, Silvia Jimenezjorge, Esteban Fernandezhinojosa, Dimitrios K Matthaiou, Paula Ramirez, Ramon Ortiz Diazmiguel, Angel EstellaAbstract:Colistin is recommended in the Empirical Treatment of ventilator-associated pneumonia (VAP) with a high prevalence of carbapenem-resistant gram-negative bacilli (CR-GNB). However, the efficacy and safety of colistin are not well defined. A multicenter prospective randomized trial conducted in 32 European centers compared the efficacy and safety of colistin (4.5 million unit loading dose followed by a maintenance dose of 3 million units every 8 h) versus meropenem (2 g every 8 h), both in combination with levofloxacin (500 mg every 12 h) for 7–14 days in patients with late VAP. Between May 2012 and October 2015, 232 patients were randomly assigned to the 2 Treatment groups. The primary endpoint was mortality at 28 days after randomization in the microbiologically modified intention-to-treat (mMITT) population. Secondary outcomes included clinical and microbiological cure, renal function at the end of the Treatment, and serious adverse events. The study was interrupted after the interim analysis due to excessive nephrotoxicity in the colistin group; therefore, the sample size was not achieved. A total of 157 (67.7%) patients were included in the mMITT population, 36 of whom (22.9%) had VAP caused by CR-GNB. In the mMITT population, no significant difference in mortality between the colistin group (19/82, 23.2%) and the meropenem group (19/75, 25.3%) was observed, with a risk difference of − 2.16 (− 15.59 to 11.26, p = 0.377); the noninferiority of colistin was not demonstrated due to early termination and limited number of patients infected by carbapenem-resistant pathogens. Colistin plus levofloxacin increased the incidence of renal failure (40/120, 33.3%, versus 21/112, 18.8%; p = 0.012) and renal replacement therapy (11/120, 9.1%, versus 2/112, 1.8%; p = 0.015). This study did not demonstrate the noninferiority of colistin compared with meropenem, both combined with levofloxacin, in terms of efficacy in the Empirical Treatment of late VAP but demonstrated the greater nephrotoxicity of colistin. These findings do not support the Empirical use of colistin for the Treatment of late VAP due to early termination. ClinicalTrials.gov, NCT01292031. Registered 9 February 2011.
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safety and efficacy of colistin versus meropenem in the Empirical Treatment of ventilator associated pneumonia as part of a macro project funded by the seventh framework program of the european commission studying off patent antibiotics study protocol for a randomized controlled trial
Trials, 2015Co-Authors: Clara Rossofernandez, Jose Garnachomontero, M Antonelli, George Dimopoulos, Jose Miguel CisnerosAbstract:Background Ventilator-associated pneumonia (VAP) is one of the most common and severe hospital-adquired infections, and multidrugresistant gram-negative bacilli (MDR-GNB) constitute the main etiology in many countries. Inappropriate empiric antimicrobial Treatment is associated with increased mortality. In this context, the Empirical Treatment of choice for VAP is unknown. Colistin, is now the antimicrobial with greatest in vitro activity against MDR-GNB.
Melissa M Hudson - One of the best experts on this subject based on the ideXlab platform.
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oral cefixime is similar to continued intravenous antibiotics in the Empirical Treatment of febrile neutropenic children with cancer
Clinical Infectious Diseases, 2001Co-Authors: Jerry L Shenep, Donald K Baker, Patricia M Flynn, Seth Hetherington, Melissa M HudsonAbstract:Empiric oral antibiotic therapy for febrile neutropenic cancer patients has been suggested as a means to decrease hospitalization, but the safety of this approach has not been adequately studied in children. We compared continued iv antibiotic therapy with switching Treatment to orally administered cefixime in a group of selected febrile neutropenic children for whom blood cultures were sterile after 48 h of incubation. Two hundred episodes of febrile neutropenia were studied (156 patients), and 100 episodes were randomized to receive each Treatment. Failure to respond to therapy was defined by documented or suspected bacterial infection, recurrent fever, or discontinuation of assigned therapy for any reason before neutropenia resolved. Rates of Treatment failure were similar in the oral cefixime group (28%) and in the iv antibiotic group (27%; P=1.0). Results support the safety of oral cefixime therapy for low-risk febrile neutropenic children, a therapeutic approach that would facilitate earlier outpatient management and decrease the costs of Treatment.
Gennaro De Pascale - One of the best experts on this subject based on the ideXlab platform.
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colistin versus meropenem in the Empirical Treatment of ventilator associated pneumonia magic bullet study an investigator driven open label randomized noninferiority controlled trial
Critical Care, 2019Co-Authors: Jose Miguel Cisneros, Clara Rossofernandez, Cristina Rocaoporto, Gennaro De Pascale, Silvia Jimenezjorge, Esteban Fernandezhinojosa, Dimitrios K Matthaiou, Paula Ramirez, Ramon Ortiz Diazmiguel, Angel EstellaAbstract:Background Colistin is recommended in the Empirical Treatment of ventilator-associated pneumonia (VAP) with a high prevalence of carbapenem-resistant gram-negative bacilli (CR-GNB). However, the efficacy and safety of colistin are not well defined.
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colistin versus meropenem in the Empirical Treatment of ventilator associated pneumonia magic bullet study an investigator driven open label randomized noninferiority controlled trial
Critical Care, 2019Co-Authors: Jose Miguel Cisneros, Clara Rossofernandez, Cristina Rocaoporto, Gennaro De Pascale, Silvia Jimenezjorge, Esteban Fernandezhinojosa, Dimitrios K Matthaiou, Paula Ramirez, Ramon Ortiz Diazmiguel, Angel EstellaAbstract:Colistin is recommended in the Empirical Treatment of ventilator-associated pneumonia (VAP) with a high prevalence of carbapenem-resistant gram-negative bacilli (CR-GNB). However, the efficacy and safety of colistin are not well defined. A multicenter prospective randomized trial conducted in 32 European centers compared the efficacy and safety of colistin (4.5 million unit loading dose followed by a maintenance dose of 3 million units every 8 h) versus meropenem (2 g every 8 h), both in combination with levofloxacin (500 mg every 12 h) for 7–14 days in patients with late VAP. Between May 2012 and October 2015, 232 patients were randomly assigned to the 2 Treatment groups. The primary endpoint was mortality at 28 days after randomization in the microbiologically modified intention-to-treat (mMITT) population. Secondary outcomes included clinical and microbiological cure, renal function at the end of the Treatment, and serious adverse events. The study was interrupted after the interim analysis due to excessive nephrotoxicity in the colistin group; therefore, the sample size was not achieved. A total of 157 (67.7%) patients were included in the mMITT population, 36 of whom (22.9%) had VAP caused by CR-GNB. In the mMITT population, no significant difference in mortality between the colistin group (19/82, 23.2%) and the meropenem group (19/75, 25.3%) was observed, with a risk difference of − 2.16 (− 15.59 to 11.26, p = 0.377); the noninferiority of colistin was not demonstrated due to early termination and limited number of patients infected by carbapenem-resistant pathogens. Colistin plus levofloxacin increased the incidence of renal failure (40/120, 33.3%, versus 21/112, 18.8%; p = 0.012) and renal replacement therapy (11/120, 9.1%, versus 2/112, 1.8%; p = 0.015). This study did not demonstrate the noninferiority of colistin compared with meropenem, both combined with levofloxacin, in terms of efficacy in the Empirical Treatment of late VAP but demonstrated the greater nephrotoxicity of colistin. These findings do not support the Empirical use of colistin for the Treatment of late VAP due to early termination. ClinicalTrials.gov, NCT01292031. Registered 9 February 2011.
Clara Rossofernandez - One of the best experts on this subject based on the ideXlab platform.
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colistin versus meropenem in the Empirical Treatment of ventilator associated pneumonia magic bullet study an investigator driven open label randomized noninferiority controlled trial
Critical Care, 2019Co-Authors: Jose Miguel Cisneros, Clara Rossofernandez, Cristina Rocaoporto, Gennaro De Pascale, Silvia Jimenezjorge, Esteban Fernandezhinojosa, Dimitrios K Matthaiou, Paula Ramirez, Ramon Ortiz Diazmiguel, Angel EstellaAbstract:Background Colistin is recommended in the Empirical Treatment of ventilator-associated pneumonia (VAP) with a high prevalence of carbapenem-resistant gram-negative bacilli (CR-GNB). However, the efficacy and safety of colistin are not well defined.
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colistin versus meropenem in the Empirical Treatment of ventilator associated pneumonia magic bullet study an investigator driven open label randomized noninferiority controlled trial
Critical Care, 2019Co-Authors: Jose Miguel Cisneros, Clara Rossofernandez, Cristina Rocaoporto, Gennaro De Pascale, Silvia Jimenezjorge, Esteban Fernandezhinojosa, Dimitrios K Matthaiou, Paula Ramirez, Ramon Ortiz Diazmiguel, Angel EstellaAbstract:Colistin is recommended in the Empirical Treatment of ventilator-associated pneumonia (VAP) with a high prevalence of carbapenem-resistant gram-negative bacilli (CR-GNB). However, the efficacy and safety of colistin are not well defined. A multicenter prospective randomized trial conducted in 32 European centers compared the efficacy and safety of colistin (4.5 million unit loading dose followed by a maintenance dose of 3 million units every 8 h) versus meropenem (2 g every 8 h), both in combination with levofloxacin (500 mg every 12 h) for 7–14 days in patients with late VAP. Between May 2012 and October 2015, 232 patients were randomly assigned to the 2 Treatment groups. The primary endpoint was mortality at 28 days after randomization in the microbiologically modified intention-to-treat (mMITT) population. Secondary outcomes included clinical and microbiological cure, renal function at the end of the Treatment, and serious adverse events. The study was interrupted after the interim analysis due to excessive nephrotoxicity in the colistin group; therefore, the sample size was not achieved. A total of 157 (67.7%) patients were included in the mMITT population, 36 of whom (22.9%) had VAP caused by CR-GNB. In the mMITT population, no significant difference in mortality between the colistin group (19/82, 23.2%) and the meropenem group (19/75, 25.3%) was observed, with a risk difference of − 2.16 (− 15.59 to 11.26, p = 0.377); the noninferiority of colistin was not demonstrated due to early termination and limited number of patients infected by carbapenem-resistant pathogens. Colistin plus levofloxacin increased the incidence of renal failure (40/120, 33.3%, versus 21/112, 18.8%; p = 0.012) and renal replacement therapy (11/120, 9.1%, versus 2/112, 1.8%; p = 0.015). This study did not demonstrate the noninferiority of colistin compared with meropenem, both combined with levofloxacin, in terms of efficacy in the Empirical Treatment of late VAP but demonstrated the greater nephrotoxicity of colistin. These findings do not support the Empirical use of colistin for the Treatment of late VAP due to early termination. ClinicalTrials.gov, NCT01292031. Registered 9 February 2011.