Efficacy and safety of doripenem versus piperacillin/tazobactam in nosocomial pneumonia: a randomized, open-label, multicenter study
ABSTRACT Objective: Doripenem is a new carbapenem that has broad-spectrum activity against bacterial pathogens commonly responsible for nosocomial pneumonia (NP). It has several advantages over currently available carbapenems and other classes of drugs used in this indication. This prospective, rand...
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| creator | Réa-Neto, Álvaro Niederman, Michael Margareth Lobo, Suzana Schroeder, Eric Lee, Michael Kaniga, Koné Ketter, Nzeera Prokocimer, Philippe Friedland, Ian |
| description | ABSTRACT
Objective: Doripenem is a new carbapenem that has broad-spectrum activity against bacterial pathogens commonly responsible for nosocomial pneumonia (NP). It has several advantages over currently available carbapenems and other classes of drugs used in this indication. This prospective, randomized, open-label, multicenter study was designed to establish whether doripenem was noninferior to piperacillin/tazobactam in NP.
Methods: Adults (n = 448) with signs and symptoms of NP, including non-ventilated patients and those ventilated for 8 µg/mL occurred in 0% and 7.7%, respectively. Favorable microbiological outcome rates against Gram-negative pathogens were numerically higher with doripenem than with piperacillin/tazobactam, but the difference was not statistically significant. Both study drugs were generally well tolerated, as only 16.1% and 17.6% of patients receiving doripenem and piperacillin/tazobactam, respectively, had a drug-related adverse event. Study limitations included the open-label design, the low rate of monotherapy (adjunctive use of aminoglycoside was required when P. aeruginosa was suspected), and the exclusion of the m |
| doi_str_mv | 10.1185/03007990802179255 |
| format | Article |
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Objective: Doripenem is a new carbapenem that has broad-spectrum activity against bacterial pathogens commonly responsible for nosocomial pneumonia (NP). It has several advantages over currently available carbapenems and other classes of drugs used in this indication. This prospective, randomized, open-label, multicenter study was designed to establish whether doripenem was noninferior to piperacillin/tazobactam in NP.
Methods: Adults (n = 448) with signs and symptoms of NP, including non-ventilated patients and those ventilated for <5 days, were stratified by ventilation mode, illness severity (Acute Physiology and Chronic Health Evaluation II score), and geographic region and then randomly allocated to treatment with doripenem 500 mg every 8 h by a 1-h intravenous (IV) infusion or piperacillin/tazobactam 4.5 g every 6 h by 30-min IV infusion. After receiving IV study drug for at least 72 h, eligible patients could be switched to oral levofloxacin 750 mg once daily. Antibiotic therapy was continued for a total of 7–14 days. The primary endpoint was the clinical cure rate, assessed 7–14 days after treatment completion, in clinically evaluable patients and in the clinical modified intent-to-treat population (cMITT).
Trial registration: ClinicalTrials.gov, NCT00211003.
Results: Doripenem was noninferior to piperacillin/tazobactam. Clinical cure rates in clinically evaluable patients (n = 253) were 81.3% in the doripenem arm and 79.8% in the piperacillin/tazobactam arm (between-treatment difference: 1.5%; 95% confidence interval [CI], −9.1 to 12.1%) and in the cMITT population 69.5% and 64.1%, respectively, (between-treatment difference: 5.4%; 95% CI, −4.1 to 14.8%). Baseline resistance of Klebsiella pneumoniae and Pseudomonas aeruginosa to piperacillin/tazobactam was 44% and 26.9%, respectively; a doripenem minimum inhibitory concentration (MIC) >8 µg/mL occurred in 0% and 7.7%, respectively. Favorable microbiological outcome rates against Gram-negative pathogens were numerically higher with doripenem than with piperacillin/tazobactam, but the difference was not statistically significant. Both study drugs were generally well tolerated, as only 16.1% and 17.6% of patients receiving doripenem and piperacillin/tazobactam, respectively, had a drug-related adverse event. Study limitations included the open-label design, the low rate of monotherapy (adjunctive use of aminoglycoside was required when P. aeruginosa was suspected), and the exclusion of the most critically ill and immunocompromized patients.
Conclusions: Doripenem was clinically and microbiologically effective in patents with NP, including those with early-onset ventilator-associated pneumonia, and was therapeutically noninferior to piperacillin/tazobactam.</description><identifier>ISSN: 0300-7995</identifier><identifier>EISSN: 1473-4877</identifier><identifier>DOI: 10.1185/03007990802179255</identifier><identifier>PMID: 18549664</identifier><identifier>CODEN: CMROCX</identifier><language>eng</language><publisher>England: Informa UK Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Anti-Bacterial Agents - therapeutic use ; Bacteria - drug effects ; Bacteria - isolation & purification ; Carbapenem ; Carbapenems - therapeutic use ; Cross Infection - drug therapy ; Cross Infection - microbiology ; Doripenem ; Female ; Humans ; Klebsiella pneumoniae ; Male ; Middle Aged ; Penicillanic Acid - analogs & derivatives ; Penicillanic Acid - therapeutic use ; Piperacillin - therapeutic use ; Pneumonia, Bacterial - drug therapy ; Prospective Studies ; Pseudomonas aeruginosa ; Tazobactam ; Treatment Outcome ; Ventilator-associated pneumonia</subject><ispartof>Current medical research and opinion, 2008-07, Vol.24 (7), p.2113-2126</ispartof><rights>2008 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted 2008</rights><rights>Copyright Librapharm Jul 2008</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c497t-f0b0d6adf9e9597cfe807ccc6eccb8b6232250661d7f2d34e5306cddc000344d3</citedby><cites>FETCH-LOGICAL-c497t-f0b0d6adf9e9597cfe807ccc6eccb8b6232250661d7f2d34e5306cddc000344d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.tandfonline.com/doi/pdf/10.1185/03007990802179255$$EPDF$$P50$$Ginformahealthcare$$H</linktopdf><linktohtml>$$Uhttps://www.tandfonline.com/doi/full/10.1185/03007990802179255$$EHTML$$P50$$Ginformahealthcare$$H</linktohtml><link.rule.ids>314,776,780,27903,27904,59623,59729,60412,60518,61197,61232,61378,61413</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18549664$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Réa-Neto, Álvaro</creatorcontrib><creatorcontrib>Niederman, Michael</creatorcontrib><creatorcontrib>Margareth Lobo, Suzana</creatorcontrib><creatorcontrib>Schroeder, Eric</creatorcontrib><creatorcontrib>Lee, Michael</creatorcontrib><creatorcontrib>Kaniga, Koné</creatorcontrib><creatorcontrib>Ketter, Nzeera</creatorcontrib><creatorcontrib>Prokocimer, Philippe</creatorcontrib><creatorcontrib>Friedland, Ian</creatorcontrib><title>Efficacy and safety of doripenem versus piperacillin/tazobactam in nosocomial pneumonia: a randomized, open-label, multicenter study</title><title>Current medical research and opinion</title><addtitle>Curr Med Res Opin</addtitle><description>ABSTRACT
Objective: Doripenem is a new carbapenem that has broad-spectrum activity against bacterial pathogens commonly responsible for nosocomial pneumonia (NP). It has several advantages over currently available carbapenems and other classes of drugs used in this indication. This prospective, randomized, open-label, multicenter study was designed to establish whether doripenem was noninferior to piperacillin/tazobactam in NP.
Methods: Adults (n = 448) with signs and symptoms of NP, including non-ventilated patients and those ventilated for <5 days, were stratified by ventilation mode, illness severity (Acute Physiology and Chronic Health Evaluation II score), and geographic region and then randomly allocated to treatment with doripenem 500 mg every 8 h by a 1-h intravenous (IV) infusion or piperacillin/tazobactam 4.5 g every 6 h by 30-min IV infusion. After receiving IV study drug for at least 72 h, eligible patients could be switched to oral levofloxacin 750 mg once daily. Antibiotic therapy was continued for a total of 7–14 days. The primary endpoint was the clinical cure rate, assessed 7–14 days after treatment completion, in clinically evaluable patients and in the clinical modified intent-to-treat population (cMITT).
Trial registration: ClinicalTrials.gov, NCT00211003.
Results: Doripenem was noninferior to piperacillin/tazobactam. Clinical cure rates in clinically evaluable patients (n = 253) were 81.3% in the doripenem arm and 79.8% in the piperacillin/tazobactam arm (between-treatment difference: 1.5%; 95% confidence interval [CI], −9.1 to 12.1%) and in the cMITT population 69.5% and 64.1%, respectively, (between-treatment difference: 5.4%; 95% CI, −4.1 to 14.8%). Baseline resistance of Klebsiella pneumoniae and Pseudomonas aeruginosa to piperacillin/tazobactam was 44% and 26.9%, respectively; a doripenem minimum inhibitory concentration (MIC) >8 µg/mL occurred in 0% and 7.7%, respectively. Favorable microbiological outcome rates against Gram-negative pathogens were numerically higher with doripenem than with piperacillin/tazobactam, but the difference was not statistically significant. Both study drugs were generally well tolerated, as only 16.1% and 17.6% of patients receiving doripenem and piperacillin/tazobactam, respectively, had a drug-related adverse event. Study limitations included the open-label design, the low rate of monotherapy (adjunctive use of aminoglycoside was required when P. aeruginosa was suspected), and the exclusion of the most critically ill and immunocompromized patients.
Conclusions: Doripenem was clinically and microbiologically effective in patents with NP, including those with early-onset ventilator-associated pneumonia, and was therapeutically noninferior to piperacillin/tazobactam.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anti-Bacterial Agents - therapeutic use</subject><subject>Bacteria - drug effects</subject><subject>Bacteria - isolation & purification</subject><subject>Carbapenem</subject><subject>Carbapenems - therapeutic use</subject><subject>Cross Infection - drug therapy</subject><subject>Cross Infection - microbiology</subject><subject>Doripenem</subject><subject>Female</subject><subject>Humans</subject><subject>Klebsiella pneumoniae</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Penicillanic Acid - analogs & derivatives</subject><subject>Penicillanic Acid - therapeutic use</subject><subject>Piperacillin - therapeutic use</subject><subject>Pneumonia, Bacterial - drug therapy</subject><subject>Prospective Studies</subject><subject>Pseudomonas aeruginosa</subject><subject>Tazobactam</subject><subject>Treatment Outcome</subject><subject>Ventilator-associated pneumonia</subject><issn>0300-7995</issn><issn>1473-4877</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp9kU1vFSEUhonR2Gv1B7gxxIWrjmWYGT7UTdPUj6SJG11PGDikNAyMwNRM1_3h0tybNGp0RYDnfQLnRehlS962rRhOSUcIl5IIQlsu6TA8Qru2513TC84fo939fVOB4Qg9y_makJYKKZ-ioxruJWP9Dt1dWOu00htWweCsLJQNR4tNTG6BADO-gZTXjJe6TUo77104Leo2TkoXNWMXcIg56jg75fESYJ1jcOodVjhVZT2-BXOCY5U1Xk3gT_C8-uI0hAIJ57Ka7Tl6YpXP8OKwHqPvHy--nX9uLr9--nJ-dtnoXvLSWDIRw5SxEuQgubYgCNdaM9B6EhOjHaUDYaw13FLT9TB0hGljNCGk63vTHaM3e--S4o8VchlnlzV4rwLENY9MUsH6gVfw9R_gdVxTqG8baZ24EFTQCrV7SKeYcwI7LsnNKm1jS8b7fsa_-qmZVwfxOs1gHhKHQirwYQ-4YGOa1c-YvBmL2nxMtg5Uuzx2__O__y1-BcqXK60SPPzg3-lfeciy8Q</recordid><startdate>20080701</startdate><enddate>20080701</enddate><creator>Réa-Neto, Álvaro</creator><creator>Niederman, Michael</creator><creator>Margareth Lobo, Suzana</creator><creator>Schroeder, Eric</creator><creator>Lee, Michael</creator><creator>Kaniga, Koné</creator><creator>Ketter, Nzeera</creator><creator>Prokocimer, Philippe</creator><creator>Friedland, Ian</creator><general>Informa UK Ltd</general><general>Taylor & Francis</general><general>Informa Healthcare</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>S0X</scope><scope>7X8</scope></search><sort><creationdate>20080701</creationdate><title>Efficacy and safety of doripenem versus piperacillin/tazobactam in nosocomial pneumonia: a randomized, open-label, multicenter study</title><author>Réa-Neto, Álvaro ; Niederman, Michael ; Margareth Lobo, Suzana ; Schroeder, Eric ; Lee, Michael ; Kaniga, Koné ; Ketter, Nzeera ; Prokocimer, Philippe ; Friedland, Ian</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c497t-f0b0d6adf9e9597cfe807ccc6eccb8b6232250661d7f2d34e5306cddc000344d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anti-Bacterial Agents - therapeutic use</topic><topic>Bacteria - drug effects</topic><topic>Bacteria - isolation & purification</topic><topic>Carbapenem</topic><topic>Carbapenems - therapeutic use</topic><topic>Cross Infection - drug therapy</topic><topic>Cross Infection - microbiology</topic><topic>Doripenem</topic><topic>Female</topic><topic>Humans</topic><topic>Klebsiella pneumoniae</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Penicillanic Acid - analogs & derivatives</topic><topic>Penicillanic Acid - therapeutic use</topic><topic>Piperacillin - therapeutic use</topic><topic>Pneumonia, Bacterial - drug therapy</topic><topic>Prospective Studies</topic><topic>Pseudomonas aeruginosa</topic><topic>Tazobactam</topic><topic>Treatment Outcome</topic><topic>Ventilator-associated pneumonia</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Réa-Neto, Álvaro</creatorcontrib><creatorcontrib>Niederman, Michael</creatorcontrib><creatorcontrib>Margareth Lobo, Suzana</creatorcontrib><creatorcontrib>Schroeder, Eric</creatorcontrib><creatorcontrib>Lee, Michael</creatorcontrib><creatorcontrib>Kaniga, Koné</creatorcontrib><creatorcontrib>Ketter, Nzeera</creatorcontrib><creatorcontrib>Prokocimer, Philippe</creatorcontrib><creatorcontrib>Friedland, Ian</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Science Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><jtitle>Current medical research and opinion</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Réa-Neto, Álvaro</au><au>Niederman, Michael</au><au>Margareth Lobo, Suzana</au><au>Schroeder, Eric</au><au>Lee, Michael</au><au>Kaniga, Koné</au><au>Ketter, Nzeera</au><au>Prokocimer, Philippe</au><au>Friedland, Ian</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of doripenem versus piperacillin/tazobactam in nosocomial pneumonia: a randomized, open-label, multicenter study</atitle><jtitle>Current medical research and opinion</jtitle><addtitle>Curr Med Res Opin</addtitle><date>2008-07-01</date><risdate>2008</risdate><volume>24</volume><issue>7</issue><spage>2113</spage><epage>2126</epage><pages>2113-2126</pages><issn>0300-7995</issn><eissn>1473-4877</eissn><coden>CMROCX</coden><abstract>ABSTRACT
Objective: Doripenem is a new carbapenem that has broad-spectrum activity against bacterial pathogens commonly responsible for nosocomial pneumonia (NP). It has several advantages over currently available carbapenems and other classes of drugs used in this indication. This prospective, randomized, open-label, multicenter study was designed to establish whether doripenem was noninferior to piperacillin/tazobactam in NP.
Methods: Adults (n = 448) with signs and symptoms of NP, including non-ventilated patients and those ventilated for <5 days, were stratified by ventilation mode, illness severity (Acute Physiology and Chronic Health Evaluation II score), and geographic region and then randomly allocated to treatment with doripenem 500 mg every 8 h by a 1-h intravenous (IV) infusion or piperacillin/tazobactam 4.5 g every 6 h by 30-min IV infusion. After receiving IV study drug for at least 72 h, eligible patients could be switched to oral levofloxacin 750 mg once daily. Antibiotic therapy was continued for a total of 7–14 days. The primary endpoint was the clinical cure rate, assessed 7–14 days after treatment completion, in clinically evaluable patients and in the clinical modified intent-to-treat population (cMITT).
Trial registration: ClinicalTrials.gov, NCT00211003.
Results: Doripenem was noninferior to piperacillin/tazobactam. Clinical cure rates in clinically evaluable patients (n = 253) were 81.3% in the doripenem arm and 79.8% in the piperacillin/tazobactam arm (between-treatment difference: 1.5%; 95% confidence interval [CI], −9.1 to 12.1%) and in the cMITT population 69.5% and 64.1%, respectively, (between-treatment difference: 5.4%; 95% CI, −4.1 to 14.8%). Baseline resistance of Klebsiella pneumoniae and Pseudomonas aeruginosa to piperacillin/tazobactam was 44% and 26.9%, respectively; a doripenem minimum inhibitory concentration (MIC) >8 µg/mL occurred in 0% and 7.7%, respectively. Favorable microbiological outcome rates against Gram-negative pathogens were numerically higher with doripenem than with piperacillin/tazobactam, but the difference was not statistically significant. Both study drugs were generally well tolerated, as only 16.1% and 17.6% of patients receiving doripenem and piperacillin/tazobactam, respectively, had a drug-related adverse event. Study limitations included the open-label design, the low rate of monotherapy (adjunctive use of aminoglycoside was required when P. aeruginosa was suspected), and the exclusion of the most critically ill and immunocompromized patients.
Conclusions: Doripenem was clinically and microbiologically effective in patents with NP, including those with early-onset ventilator-associated pneumonia, and was therapeutically noninferior to piperacillin/tazobactam.</abstract><cop>England</cop><pub>Informa UK Ltd</pub><pmid>18549664</pmid><doi>10.1185/03007990802179255</doi><tpages>14</tpages></addata></record> |
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| ispartof | Current medical research and opinion, 2008-07, Vol.24 (7), p.2113-2126 |
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| subjects | Adult Aged Aged, 80 and over Anti-Bacterial Agents - therapeutic use Bacteria - drug effects Bacteria - isolation & purification Carbapenem Carbapenems - therapeutic use Cross Infection - drug therapy Cross Infection - microbiology Doripenem Female Humans Klebsiella pneumoniae Male Middle Aged Penicillanic Acid - analogs & derivatives Penicillanic Acid - therapeutic use Piperacillin - therapeutic use Pneumonia, Bacterial - drug therapy Prospective Studies Pseudomonas aeruginosa Tazobactam Treatment Outcome Ventilator-associated pneumonia |
| title | Efficacy and safety of doripenem versus piperacillin/tazobactam in nosocomial pneumonia: a randomized, open-label, multicenter study |
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