Comparison of Levofloxacin and Cefotaxime Combined With Ofloxacin for ICU Patients With Community-Acquired Pneumonia Who Do Not Require Vasopressors
To evaluate the efficacy and tolerability of levofloxacin (L) as monotherapy in patients with severe community-acquired pneumonia (CAP) in comparison with therapy using a combination of cefotaxime (C) plus ofloxacin (O). Prospective, randomized 1:1, comparative, open, parallel-group study. Multinati...
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| Veröffentlicht in: | Chest 2005-07, Vol.128 (1), p.172-183 |
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| creator | Leroy, Olivier Saux, Pierre Bédos, Jean-Pierre Caulin, Evelyne |
| description | To evaluate the efficacy and tolerability of levofloxacin (L) as monotherapy in patients with severe community-acquired pneumonia (CAP) in comparison with therapy using a combination of cefotaxime (C) plus ofloxacin (O).
Prospective, randomized 1:1, comparative, open, parallel-group study.
Multinational study with 149 sites.
A total of 398 randomized patients who had been admitted to the ICU with severe CAP without shock, including 308 patients in a modified intent-to-treat population and 271 patients in the per-protocol (PP) population (L group, 139 patients; C + O group, 132 patients).
Therapy with levofloxacin (500 mg IV, q12h) vs therapy with a C + O combination (C, 1g IV, q8h; O, 200 mg IV, q12h) for 10 to 14 days.
The main end point was the clinical efficacy at the end of treatment (ie, the test-of-cure [TOC] visit). The statistical hypothesis was the noninferiority of L therapy to C + O therapy with a 2.5% α risk (unilateral) and a 15% maximum set difference. At the TOC visit, a clinical success was observed in 79.1% of patients (L group) and 79.5% of patients (C + O group) in the PP population (difference, –0.4%; 95% confidence interval [CI], −10.79 to 9.97% without adjustment for simplified acute physiology score [SAPS] II at inclusion; difference, −0.3%; 95% CI, −10.13 to 9.58% with adjustment for SAPS II). A satisfactory bacteriologic response was present in 73.7% of L group patients and 77.5% of C + O group patients, including responses of 75.7% and 70.3%, respectively, in the L group and C + O group in the Streptococcus pneumoniae-documented population. In the safety analysis, 20 patients in the L group (10.3%) and 16 patients in the C + O group (8.0%) experienced at least one adverse event that was considered to be treatment-related.
L therapy was at least as effective as the combination therapy of C + O in the treatment of a subset of patients with CAP requiring ICU admission. This conclusion cannot be extrapolated to patients requiring mechanical ventilation or vasopressors (ie, those patients in shock). |
| doi_str_mv | 10.1378/chest.128.1.172 |
| format | Article |
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Prospective, randomized 1:1, comparative, open, parallel-group study.
Multinational study with 149 sites.
A total of 398 randomized patients who had been admitted to the ICU with severe CAP without shock, including 308 patients in a modified intent-to-treat population and 271 patients in the per-protocol (PP) population (L group, 139 patients; C + O group, 132 patients).
Therapy with levofloxacin (500 mg IV, q12h) vs therapy with a C + O combination (C, 1g IV, q8h; O, 200 mg IV, q12h) for 10 to 14 days.
The main end point was the clinical efficacy at the end of treatment (ie, the test-of-cure [TOC] visit). The statistical hypothesis was the noninferiority of L therapy to C + O therapy with a 2.5% α risk (unilateral) and a 15% maximum set difference. At the TOC visit, a clinical success was observed in 79.1% of patients (L group) and 79.5% of patients (C + O group) in the PP population (difference, –0.4%; 95% confidence interval [CI], −10.79 to 9.97% without adjustment for simplified acute physiology score [SAPS] II at inclusion; difference, −0.3%; 95% CI, −10.13 to 9.58% with adjustment for SAPS II). A satisfactory bacteriologic response was present in 73.7% of L group patients and 77.5% of C + O group patients, including responses of 75.7% and 70.3%, respectively, in the L group and C + O group in the Streptococcus pneumoniae-documented population. In the safety analysis, 20 patients in the L group (10.3%) and 16 patients in the C + O group (8.0%) experienced at least one adverse event that was considered to be treatment-related.
L therapy was at least as effective as the combination therapy of C + O in the treatment of a subset of patients with CAP requiring ICU admission. This conclusion cannot be extrapolated to patients requiring mechanical ventilation or vasopressors (ie, those patients in shock).</description><identifier>ISSN: 0012-3692</identifier><identifier>EISSN: 1931-3543</identifier><identifier>DOI: 10.1378/chest.128.1.172</identifier><identifier>PMID: 16002932</identifier><identifier>CODEN: CHETBF</identifier><language>eng</language><publisher>Northbrook, IL: Elsevier Inc</publisher><subject>Adult ; Aged ; Anti-Bacterial Agents - administration & dosage ; Antibacterial agents ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Bacterial pneumonia ; Biological and medical sciences ; Cardiology. Vascular system ; Cefotaxime ; Cefotaxime - administration & dosage ; Chi-Square Distribution ; Community-Acquired Infections - drug therapy ; community-acquired pneumonia ; Dosage and administration ; Drug therapy ; Drug Therapy, Combination ; Female ; Humans ; ICU ; Infusions, Intravenous ; Intensive Care Units ; Levofloxacin ; Male ; Medical sciences ; Middle Aged ; Ofloxacin - administration & dosage ; Pharmacology. Drug treatments ; Pneumology ; Pneumonia ; Pneumonia, Bacterial - drug therapy ; Prospective Studies ; Services ; Streptococcus pneumoniae ; Treatment Outcome</subject><ispartof>Chest, 2005-07, Vol.128 (1), p.172-183</ispartof><rights>2005 The American College of Chest Physicians</rights><rights>2005 INIST-CNRS</rights><rights>COPYRIGHT 2005 Elsevier B.V.</rights><rights>Copyright American College of Chest Physicians Jul 2005</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c519t-9e58740b9012b39310a09cff94f13bafe64364bb46be4b9d4eebb570a0c7c4c53</citedby><cites>FETCH-LOGICAL-c519t-9e58740b9012b39310a09cff94f13bafe64364bb46be4b9d4eebb570a0c7c4c53</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,778,782,27907,27908</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16968946$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16002932$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Leroy, Olivier</creatorcontrib><creatorcontrib>Saux, Pierre</creatorcontrib><creatorcontrib>Bédos, Jean-Pierre</creatorcontrib><creatorcontrib>Caulin, Evelyne</creatorcontrib><creatorcontrib>for the Levofloxacin Study Group</creatorcontrib><title>Comparison of Levofloxacin and Cefotaxime Combined With Ofloxacin for ICU Patients With Community-Acquired Pneumonia Who Do Not Require Vasopressors</title><title>Chest</title><addtitle>Chest</addtitle><description>To evaluate the efficacy and tolerability of levofloxacin (L) as monotherapy in patients with severe community-acquired pneumonia (CAP) in comparison with therapy using a combination of cefotaxime (C) plus ofloxacin (O).
Prospective, randomized 1:1, comparative, open, parallel-group study.
Multinational study with 149 sites.
A total of 398 randomized patients who had been admitted to the ICU with severe CAP without shock, including 308 patients in a modified intent-to-treat population and 271 patients in the per-protocol (PP) population (L group, 139 patients; C + O group, 132 patients).
Therapy with levofloxacin (500 mg IV, q12h) vs therapy with a C + O combination (C, 1g IV, q8h; O, 200 mg IV, q12h) for 10 to 14 days.
The main end point was the clinical efficacy at the end of treatment (ie, the test-of-cure [TOC] visit). The statistical hypothesis was the noninferiority of L therapy to C + O therapy with a 2.5% α risk (unilateral) and a 15% maximum set difference. At the TOC visit, a clinical success was observed in 79.1% of patients (L group) and 79.5% of patients (C + O group) in the PP population (difference, –0.4%; 95% confidence interval [CI], −10.79 to 9.97% without adjustment for simplified acute physiology score [SAPS] II at inclusion; difference, −0.3%; 95% CI, −10.13 to 9.58% with adjustment for SAPS II). A satisfactory bacteriologic response was present in 73.7% of L group patients and 77.5% of C + O group patients, including responses of 75.7% and 70.3%, respectively, in the L group and C + O group in the Streptococcus pneumoniae-documented population. In the safety analysis, 20 patients in the L group (10.3%) and 16 patients in the C + O group (8.0%) experienced at least one adverse event that was considered to be treatment-related.
L therapy was at least as effective as the combination therapy of C + O in the treatment of a subset of patients with CAP requiring ICU admission. This conclusion cannot be extrapolated to patients requiring mechanical ventilation or vasopressors (ie, those patients in shock).</description><subject>Adult</subject><subject>Aged</subject><subject>Anti-Bacterial Agents - administration & dosage</subject><subject>Antibacterial agents</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Bacterial pneumonia</subject><subject>Biological and medical sciences</subject><subject>Cardiology. Vascular system</subject><subject>Cefotaxime</subject><subject>Cefotaxime - administration & dosage</subject><subject>Chi-Square Distribution</subject><subject>Community-Acquired Infections - drug therapy</subject><subject>community-acquired pneumonia</subject><subject>Dosage and administration</subject><subject>Drug therapy</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Humans</subject><subject>ICU</subject><subject>Infusions, Intravenous</subject><subject>Intensive Care Units</subject><subject>Levofloxacin</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Ofloxacin - administration & dosage</subject><subject>Pharmacology. Drug treatments</subject><subject>Pneumology</subject><subject>Pneumonia</subject><subject>Pneumonia, Bacterial - drug therapy</subject><subject>Prospective Studies</subject><subject>Services</subject><subject>Streptococcus pneumoniae</subject><subject>Treatment Outcome</subject><issn>0012-3692</issn><issn>1931-3543</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kk1v1DAQhiMEokvhzA1ZSHDL1o6dZH1cLV-VVrRClB4txxnvukrsrZ2U9n_wg5k2K1ihIh8s2887M555s-w1o3PG68WJ2UIa5qxYzNmc1cWTbMYkZzkvBX-azShlRc4rWRxlL1K6onhmsnqeHbGK0kLyYpb9WoV-p6NLwZNgyRpugu3CrTbOE-1bsgIbBn3reiBINs5DSy7dsCVnfzAbIjldXZBzPTjwQ5reke5H74a7fGmuRxdRd-5h7IN3mlxuA_kQyNcwkG_w8Ep-6BR2EVIKMb3MnlndJXi134-zi08fv6--5Ouzz6er5To3JZNDLqFc1II2Er_ZcPw31VQaa6WwjDfaQiV4JZpGVA2IRrYCoGnKGilTG2FKfpy9n-LuYrgesZOqd8lA12kPYUyqWlAqS3EPvv0HvApj9FibKigVpWSsRiifoI3uQDmPjYvabMBD1F3wYB1eLxkXsmCLukJ-_giPq4XemUcFJ5PAxJBSBKt20fU63ilG1b0d1IMdFNpBMYV2QMWbfd1j00P7l9_PH4F3e0AnozsbtTcuHXCyWkhxkHrrNtufOC-Vet11GJZPSff9OEwtJwXgAG8cRJUM2sNAi2ozqDa4_5b9G5js4-4</recordid><startdate>20050701</startdate><enddate>20050701</enddate><creator>Leroy, Olivier</creator><creator>Saux, Pierre</creator><creator>Bédos, Jean-Pierre</creator><creator>Caulin, Evelyne</creator><general>Elsevier Inc</general><general>American College of Chest Physicians</general><general>Elsevier B.V</general><scope>IQODW</scope><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>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</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>FYUFA</scope><scope>GHDGH</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20050701</creationdate><title>Comparison of Levofloxacin and Cefotaxime Combined With Ofloxacin for ICU Patients With Community-Acquired Pneumonia Who Do Not Require Vasopressors</title><author>Leroy, Olivier ; Saux, Pierre ; Bédos, Jean-Pierre ; Caulin, Evelyne</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c519t-9e58740b9012b39310a09cff94f13bafe64364bb46be4b9d4eebb570a0c7c4c53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Anti-Bacterial Agents - administration & dosage</topic><topic>Antibacterial agents</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Bacterial pneumonia</topic><topic>Biological and medical sciences</topic><topic>Cardiology. Vascular system</topic><topic>Cefotaxime</topic><topic>Cefotaxime - administration & dosage</topic><topic>Chi-Square Distribution</topic><topic>Community-Acquired Infections - drug therapy</topic><topic>community-acquired pneumonia</topic><topic>Dosage and administration</topic><topic>Drug therapy</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Humans</topic><topic>ICU</topic><topic>Infusions, Intravenous</topic><topic>Intensive Care Units</topic><topic>Levofloxacin</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Ofloxacin - administration & dosage</topic><topic>Pharmacology. Drug treatments</topic><topic>Pneumology</topic><topic>Pneumonia</topic><topic>Pneumonia, Bacterial - drug therapy</topic><topic>Prospective Studies</topic><topic>Services</topic><topic>Streptococcus pneumoniae</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Leroy, Olivier</creatorcontrib><creatorcontrib>Saux, Pierre</creatorcontrib><creatorcontrib>Bédos, Jean-Pierre</creatorcontrib><creatorcontrib>Caulin, Evelyne</creatorcontrib><creatorcontrib>for the Levofloxacin Study Group</creatorcontrib><collection>Pascal-Francis</collection><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>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</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>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</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>MEDLINE - Academic</collection><jtitle>Chest</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Leroy, Olivier</au><au>Saux, Pierre</au><au>Bédos, Jean-Pierre</au><au>Caulin, Evelyne</au><aucorp>for the Levofloxacin Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparison of Levofloxacin and Cefotaxime Combined With Ofloxacin for ICU Patients With Community-Acquired Pneumonia Who Do Not Require Vasopressors</atitle><jtitle>Chest</jtitle><addtitle>Chest</addtitle><date>2005-07-01</date><risdate>2005</risdate><volume>128</volume><issue>1</issue><spage>172</spage><epage>183</epage><pages>172-183</pages><issn>0012-3692</issn><eissn>1931-3543</eissn><coden>CHETBF</coden><abstract>To evaluate the efficacy and tolerability of levofloxacin (L) as monotherapy in patients with severe community-acquired pneumonia (CAP) in comparison with therapy using a combination of cefotaxime (C) plus ofloxacin (O).
Prospective, randomized 1:1, comparative, open, parallel-group study.
Multinational study with 149 sites.
A total of 398 randomized patients who had been admitted to the ICU with severe CAP without shock, including 308 patients in a modified intent-to-treat population and 271 patients in the per-protocol (PP) population (L group, 139 patients; C + O group, 132 patients).
Therapy with levofloxacin (500 mg IV, q12h) vs therapy with a C + O combination (C, 1g IV, q8h; O, 200 mg IV, q12h) for 10 to 14 days.
The main end point was the clinical efficacy at the end of treatment (ie, the test-of-cure [TOC] visit). The statistical hypothesis was the noninferiority of L therapy to C + O therapy with a 2.5% α risk (unilateral) and a 15% maximum set difference. At the TOC visit, a clinical success was observed in 79.1% of patients (L group) and 79.5% of patients (C + O group) in the PP population (difference, –0.4%; 95% confidence interval [CI], −10.79 to 9.97% without adjustment for simplified acute physiology score [SAPS] II at inclusion; difference, −0.3%; 95% CI, −10.13 to 9.58% with adjustment for SAPS II). A satisfactory bacteriologic response was present in 73.7% of L group patients and 77.5% of C + O group patients, including responses of 75.7% and 70.3%, respectively, in the L group and C + O group in the Streptococcus pneumoniae-documented population. In the safety analysis, 20 patients in the L group (10.3%) and 16 patients in the C + O group (8.0%) experienced at least one adverse event that was considered to be treatment-related.
L therapy was at least as effective as the combination therapy of C + O in the treatment of a subset of patients with CAP requiring ICU admission. This conclusion cannot be extrapolated to patients requiring mechanical ventilation or vasopressors (ie, those patients in shock).</abstract><cop>Northbrook, IL</cop><pub>Elsevier Inc</pub><pmid>16002932</pmid><doi>10.1378/chest.128.1.172</doi><tpages>12</tpages></addata></record> |
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| ispartof | Chest, 2005-07, Vol.128 (1), p.172-183 |
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| subjects | Adult Aged Anti-Bacterial Agents - administration & dosage Antibacterial agents Antibiotics. Antiinfectious agents. Antiparasitic agents Bacterial pneumonia Biological and medical sciences Cardiology. Vascular system Cefotaxime Cefotaxime - administration & dosage Chi-Square Distribution Community-Acquired Infections - drug therapy community-acquired pneumonia Dosage and administration Drug therapy Drug Therapy, Combination Female Humans ICU Infusions, Intravenous Intensive Care Units Levofloxacin Male Medical sciences Middle Aged Ofloxacin - administration & dosage Pharmacology. Drug treatments Pneumology Pneumonia Pneumonia, Bacterial - drug therapy Prospective Studies Services Streptococcus pneumoniae Treatment Outcome |
| title | Comparison of Levofloxacin and Cefotaxime Combined With Ofloxacin for ICU Patients With Community-Acquired Pneumonia Who Do Not Require Vasopressors |
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