Piperacillin/tazobactam versus imipenem/cilastatin for severe diabetic foot infections: a prospective, randomized clinical trial in a university hospital
In this prospective, randomized, open-label clinical trial, we compared the efficacy and safety of two antibiotic regimens for severe diabetic foot infections (DFI). Sixty-two in-patients with DFI received either piperacillin/tazobactam (Pip-Tazo, n = 30) (4.5 g intravenously every 8h) or imipenem/c...
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| creator | Saltoglu, N. Dalkiran, A. Tetiker, T. Bayram, H. Tasova, Y. Dalay, C. Sert, M. |
| description | In this prospective, randomized, open-label clinical trial, we compared the efficacy and safety of two antibiotic regimens for severe diabetic foot infections (DFI). Sixty-two in-patients with DFI received either piperacillin/tazobactam (Pip-Tazo, n = 30) (4.5 g intravenously every 8h) or imipenem/cilastatin (IMP, n = 32) (0.5 g intravenously every 6h). The mean duration of treatment was 21 days for Pip-Tazo and 24 days for IMP. Twenty-two (73.3%) patients in the Pip-Tazo group and 26 (81.2%) patients in the IMP group had DFI associated with osteomyelitis. Successful clinical response was seen in 14 (46.7%) patients in the Pip-Tazo group and in nine (28.1%) patients in the IMP group [relative risk (RR) 1.6 (95% CI 0.84–3.25), p 0.130]. Two patients in the IMP group and none in the PIP-Tazo group relapsed [RR 2 (0.94–4.24), p 0.058]. Eighty-nine microorganisms were isolated: 38 (43%) Gram-positive and 51(57%) Gram-negative. Among patients with positive culture, 47 (96%) had complete and two (4%) had partial microbiological response. Microbiological response rates were similar in both groups (p 1.000). Amputation was performed in 18 (60%) and 22 (69%) patients in the Pip-Tazo and IMP groups (p 0.739) respectively. Side effects were more common in the Pip-Tazo group (30% vs. 9.4%), but they were generally mild and reversible. In conclusion, although the sample size was small and the results did not reach statistical significance, Pip-Tazo produced a better clinical response rate than IMP in the treatment of severe DFI. There was no significant difference between the treatment groups with respect to microbiological response, relapse and amputation rates. |
| doi_str_mv | 10.1111/j.1469-0691.2009.03067.x |
| format | Article |
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Sixty-two in-patients with DFI received either piperacillin/tazobactam (Pip-Tazo, n = 30) (4.5 g intravenously every 8h) or imipenem/cilastatin (IMP, n = 32) (0.5 g intravenously every 6h). The mean duration of treatment was 21 days for Pip-Tazo and 24 days for IMP. Twenty-two (73.3%) patients in the Pip-Tazo group and 26 (81.2%) patients in the IMP group had DFI associated with osteomyelitis. Successful clinical response was seen in 14 (46.7%) patients in the Pip-Tazo group and in nine (28.1%) patients in the IMP group [relative risk (RR) 1.6 (95% CI 0.84–3.25), p 0.130]. Two patients in the IMP group and none in the PIP-Tazo group relapsed [RR 2 (0.94–4.24), p 0.058]. Eighty-nine microorganisms were isolated: 38 (43%) Gram-positive and 51(57%) Gram-negative. Among patients with positive culture, 47 (96%) had complete and two (4%) had partial microbiological response. Microbiological response rates were similar in both groups (p 1.000). Amputation was performed in 18 (60%) and 22 (69%) patients in the Pip-Tazo and IMP groups (p 0.739) respectively. Side effects were more common in the Pip-Tazo group (30% vs. 9.4%), but they were generally mild and reversible. In conclusion, although the sample size was small and the results did not reach statistical significance, Pip-Tazo produced a better clinical response rate than IMP in the treatment of severe DFI. There was no significant difference between the treatment groups with respect to microbiological response, relapse and amputation rates.</description><identifier>ISSN: 1198-743X</identifier><identifier>EISSN: 1469-0691</identifier><identifier>DOI: 10.1111/j.1469-0691.2009.03067.x</identifier><identifier>PMID: 19832720</identifier><language>eng</language><publisher>Oxford, UK: Elsevier Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Amputation ; Anti-Bacterial Agents - adverse effects ; Anti-Bacterial Agents - therapeutic use ; Antibacterial agents ; Antibiotics ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Associated diseases and complications ; Bacteria - classification ; Bacteria - isolation & purification ; Bacterial Infections - drug therapy ; Biological and medical sciences ; Cilastatin ; Cilastatin - adverse effects ; Cilastatin - therapeutic use ; Clinical trials ; Diabetes ; Diabetes mellitus ; Diabetes. Impaired glucose tolerance ; Diabetic Foot - complications ; diabetic foot infection ; Drug Combinations ; Endocrine pancreas. Apud cells (diseases) ; Endocrinopathies ; Female ; Foot ; Foot diseases ; Hospitals ; Hospitals, University ; Humans ; imipenem ; Imipenem - adverse effects ; Imipenem - therapeutic use ; Infection ; Infectious diseases ; Inosine monophosphate ; Male ; Medical sciences ; Medical treatment ; Microorganisms ; Middle Aged ; Osteomyelitis ; Penicillanic Acid - adverse effects ; Penicillanic Acid - analogs & derivatives ; Penicillanic Acid - therapeutic use ; Pharmacology. Drug treatments ; piperacillin ; Piperacillin - adverse effects ; Piperacillin - therapeutic use ; piperacillin-tazobactam ; Prospective Studies ; Recurrence ; Risk assessment ; Side effects ; Statistics ; tazobactam ; Time Factors ; Treatment Outcome</subject><ispartof>Clinical microbiology and infection, 2010-08, Vol.16 (8), p.1252-1257</ispartof><rights>2010 European Society of Clinical Infectious Diseases</rights><rights>2010 The Authors. 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Sixty-two in-patients with DFI received either piperacillin/tazobactam (Pip-Tazo, n = 30) (4.5 g intravenously every 8h) or imipenem/cilastatin (IMP, n = 32) (0.5 g intravenously every 6h). The mean duration of treatment was 21 days for Pip-Tazo and 24 days for IMP. Twenty-two (73.3%) patients in the Pip-Tazo group and 26 (81.2%) patients in the IMP group had DFI associated with osteomyelitis. Successful clinical response was seen in 14 (46.7%) patients in the Pip-Tazo group and in nine (28.1%) patients in the IMP group [relative risk (RR) 1.6 (95% CI 0.84–3.25), p 0.130]. Two patients in the IMP group and none in the PIP-Tazo group relapsed [RR 2 (0.94–4.24), p 0.058]. Eighty-nine microorganisms were isolated: 38 (43%) Gram-positive and 51(57%) Gram-negative. Among patients with positive culture, 47 (96%) had complete and two (4%) had partial microbiological response. Microbiological response rates were similar in both groups (p 1.000). Amputation was performed in 18 (60%) and 22 (69%) patients in the Pip-Tazo and IMP groups (p 0.739) respectively. Side effects were more common in the Pip-Tazo group (30% vs. 9.4%), but they were generally mild and reversible. In conclusion, although the sample size was small and the results did not reach statistical significance, Pip-Tazo produced a better clinical response rate than IMP in the treatment of severe DFI. There was no significant difference between the treatment groups with respect to microbiological response, relapse and amputation rates.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Amputation</subject><subject>Anti-Bacterial Agents - adverse effects</subject><subject>Anti-Bacterial Agents - therapeutic use</subject><subject>Antibacterial agents</subject><subject>Antibiotics</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Associated diseases and complications</subject><subject>Bacteria - classification</subject><subject>Bacteria - isolation & purification</subject><subject>Bacterial Infections - drug therapy</subject><subject>Biological and medical sciences</subject><subject>Cilastatin</subject><subject>Cilastatin - adverse effects</subject><subject>Cilastatin - therapeutic use</subject><subject>Clinical trials</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Diabetes. Impaired glucose tolerance</subject><subject>Diabetic Foot - complications</subject><subject>diabetic foot infection</subject><subject>Drug Combinations</subject><subject>Endocrine pancreas. Apud cells (diseases)</subject><subject>Endocrinopathies</subject><subject>Female</subject><subject>Foot</subject><subject>Foot diseases</subject><subject>Hospitals</subject><subject>Hospitals, University</subject><subject>Humans</subject><subject>imipenem</subject><subject>Imipenem - adverse effects</subject><subject>Imipenem - therapeutic use</subject><subject>Infection</subject><subject>Infectious diseases</subject><subject>Inosine monophosphate</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Medical treatment</subject><subject>Microorganisms</subject><subject>Middle Aged</subject><subject>Osteomyelitis</subject><subject>Penicillanic Acid - adverse effects</subject><subject>Penicillanic Acid - analogs & derivatives</subject><subject>Penicillanic Acid - therapeutic use</subject><subject>Pharmacology. Drug treatments</subject><subject>piperacillin</subject><subject>Piperacillin - adverse effects</subject><subject>Piperacillin - therapeutic use</subject><subject>piperacillin-tazobactam</subject><subject>Prospective Studies</subject><subject>Recurrence</subject><subject>Risk assessment</subject><subject>Side effects</subject><subject>Statistics</subject><subject>tazobactam</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>1198-743X</issn><issn>1469-0691</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkduO0zAQhiMEYg_wCsgSQtyQ1k7cOEbiAqrlIBXBBUjcWY49EVPlUGynbPdNeFsmtFokbhZf-Pj9M575s4wJvhA0ltuFkJXOeaXFouBcL3jJK7W4vped3z7cp73Qda5k-e0su4hxyzkvylI-zM7ovixUwc-zX59xB8E67DoclsnejI11yfZsDyFOkWFP7wP0SyJsTDbhwNoxsAgEAPNoG0jo6G5MDIcWXMJxiC-ZZbswxt183sMLFuzgxx5vwDNHmdDZjqWANFNAy6YB54SYDuw7qTDZ7lH2oLVdhMen9TL7-vbqy_p9vvn07sP69SZ3q0qpfCUbqS3Uhfei0Va13tpaOKULKdtGNsJ7XRVK1nWldCU0V56Llq9845WvZVVeZs-Pcem_PyaIyfQYHXSdHWCcolEruao4r4q7Sam50KVSRD79h9yOUxioDCMonC5lrThR9ZFy1KkYoDW7gL0NByO4mX02WzPbaWY7zeyz-eOzuSbpk1OCqenB_xWejCXg2QmwkXrdUv8dxluuKDkVJUriXh25n9jB4b8_YNabj_OO9G-OeiCL9gjBRIcwOPAYyHvjR7y7mt_xv9t2</recordid><startdate>201008</startdate><enddate>201008</enddate><creator>Saltoglu, N.</creator><creator>Dalkiran, A.</creator><creator>Tetiker, T.</creator><creator>Bayram, H.</creator><creator>Tasova, Y.</creator><creator>Dalay, C.</creator><creator>Sert, M.</creator><general>Elsevier Ltd</general><general>Blackwell Publishing Ltd</general><general>Wiley-Blackwell</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</scope><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>7QL</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>7X8</scope></search><sort><creationdate>201008</creationdate><title>Piperacillin/tazobactam versus imipenem/cilastatin for severe diabetic foot infections: a prospective, randomized clinical trial in a university hospital</title><author>Saltoglu, N. ; Dalkiran, A. ; Tetiker, T. ; Bayram, H. ; Tasova, Y. ; Dalay, C. ; Sert, M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5677-54b49ae82dd1b9a7fdaa81c79244fb4b1dd962748867961907d01f05dbd7d8463</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Amputation</topic><topic>Anti-Bacterial Agents - adverse effects</topic><topic>Anti-Bacterial Agents - therapeutic use</topic><topic>Antibacterial agents</topic><topic>Antibiotics</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Associated diseases and complications</topic><topic>Bacteria - classification</topic><topic>Bacteria - isolation & purification</topic><topic>Bacterial Infections - drug therapy</topic><topic>Biological and medical sciences</topic><topic>Cilastatin</topic><topic>Cilastatin - adverse effects</topic><topic>Cilastatin - therapeutic use</topic><topic>Clinical trials</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Diabetes. Impaired glucose tolerance</topic><topic>Diabetic Foot - complications</topic><topic>diabetic foot infection</topic><topic>Drug Combinations</topic><topic>Endocrine pancreas. Apud cells (diseases)</topic><topic>Endocrinopathies</topic><topic>Female</topic><topic>Foot</topic><topic>Foot diseases</topic><topic>Hospitals</topic><topic>Hospitals, University</topic><topic>Humans</topic><topic>imipenem</topic><topic>Imipenem - adverse effects</topic><topic>Imipenem - therapeutic use</topic><topic>Infection</topic><topic>Infectious diseases</topic><topic>Inosine monophosphate</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Medical treatment</topic><topic>Microorganisms</topic><topic>Middle Aged</topic><topic>Osteomyelitis</topic><topic>Penicillanic Acid - adverse effects</topic><topic>Penicillanic Acid - analogs & derivatives</topic><topic>Penicillanic Acid - therapeutic use</topic><topic>Pharmacology. Drug treatments</topic><topic>piperacillin</topic><topic>Piperacillin - adverse effects</topic><topic>Piperacillin - therapeutic use</topic><topic>piperacillin-tazobactam</topic><topic>Prospective Studies</topic><topic>Recurrence</topic><topic>Risk assessment</topic><topic>Side effects</topic><topic>Statistics</topic><topic>tazobactam</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Saltoglu, N.</creatorcontrib><creatorcontrib>Dalkiran, A.</creatorcontrib><creatorcontrib>Tetiker, T.</creatorcontrib><creatorcontrib>Bayram, H.</creatorcontrib><creatorcontrib>Tasova, Y.</creatorcontrib><creatorcontrib>Dalay, C.</creatorcontrib><creatorcontrib>Sert, M.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><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>Bacteriology Abstracts (Microbiology B)</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical microbiology and infection</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Saltoglu, N.</au><au>Dalkiran, A.</au><au>Tetiker, T.</au><au>Bayram, H.</au><au>Tasova, Y.</au><au>Dalay, C.</au><au>Sert, M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Piperacillin/tazobactam versus imipenem/cilastatin for severe diabetic foot infections: a prospective, randomized clinical trial in a university hospital</atitle><jtitle>Clinical microbiology and infection</jtitle><addtitle>Clin Microbiol Infect</addtitle><date>2010-08</date><risdate>2010</risdate><volume>16</volume><issue>8</issue><spage>1252</spage><epage>1257</epage><pages>1252-1257</pages><issn>1198-743X</issn><eissn>1469-0691</eissn><abstract>In this prospective, randomized, open-label clinical trial, we compared the efficacy and safety of two antibiotic regimens for severe diabetic foot infections (DFI). Sixty-two in-patients with DFI received either piperacillin/tazobactam (Pip-Tazo, n = 30) (4.5 g intravenously every 8h) or imipenem/cilastatin (IMP, n = 32) (0.5 g intravenously every 6h). The mean duration of treatment was 21 days for Pip-Tazo and 24 days for IMP. Twenty-two (73.3%) patients in the Pip-Tazo group and 26 (81.2%) patients in the IMP group had DFI associated with osteomyelitis. Successful clinical response was seen in 14 (46.7%) patients in the Pip-Tazo group and in nine (28.1%) patients in the IMP group [relative risk (RR) 1.6 (95% CI 0.84–3.25), p 0.130]. Two patients in the IMP group and none in the PIP-Tazo group relapsed [RR 2 (0.94–4.24), p 0.058]. Eighty-nine microorganisms were isolated: 38 (43%) Gram-positive and 51(57%) Gram-negative. Among patients with positive culture, 47 (96%) had complete and two (4%) had partial microbiological response. Microbiological response rates were similar in both groups (p 1.000). Amputation was performed in 18 (60%) and 22 (69%) patients in the Pip-Tazo and IMP groups (p 0.739) respectively. Side effects were more common in the Pip-Tazo group (30% vs. 9.4%), but they were generally mild and reversible. In conclusion, although the sample size was small and the results did not reach statistical significance, Pip-Tazo produced a better clinical response rate than IMP in the treatment of severe DFI. There was no significant difference between the treatment groups with respect to microbiological response, relapse and amputation rates.</abstract><cop>Oxford, UK</cop><pub>Elsevier Ltd</pub><pmid>19832720</pmid><doi>10.1111/j.1469-0691.2009.03067.x</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Access via Wiley Online Library; Alma/SFX Local Collection |
| subjects | Adult Aged Aged, 80 and over Amputation Anti-Bacterial Agents - adverse effects Anti-Bacterial Agents - therapeutic use Antibacterial agents Antibiotics Antibiotics. Antiinfectious agents. Antiparasitic agents Associated diseases and complications Bacteria - classification Bacteria - isolation & purification Bacterial Infections - drug therapy Biological and medical sciences Cilastatin Cilastatin - adverse effects Cilastatin - therapeutic use Clinical trials Diabetes Diabetes mellitus Diabetes. Impaired glucose tolerance Diabetic Foot - complications diabetic foot infection Drug Combinations Endocrine pancreas. Apud cells (diseases) Endocrinopathies Female Foot Foot diseases Hospitals Hospitals, University Humans imipenem Imipenem - adverse effects Imipenem - therapeutic use Infection Infectious diseases Inosine monophosphate Male Medical sciences Medical treatment Microorganisms Middle Aged Osteomyelitis Penicillanic Acid - adverse effects Penicillanic Acid - analogs & derivatives Penicillanic Acid - therapeutic use Pharmacology. Drug treatments piperacillin Piperacillin - adverse effects Piperacillin - therapeutic use piperacillin-tazobactam Prospective Studies Recurrence Risk assessment Side effects Statistics tazobactam Time Factors Treatment Outcome |
| title | Piperacillin/tazobactam versus imipenem/cilastatin for severe diabetic foot infections: a prospective, randomized clinical trial in a university hospital |
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