Safety and efficacy of levofloxacin versus rifampicin in tuberculous meningitis: an open-label randomized controlled trial
We report the efficacy and safety of levofloxacin versus rifampicin in tuberculous meningitis (TBM). In this open-label, randomized controlled trial from India, patients with TBM diagnosed on the basis of clinical, MRI and CSF findings were included. Patients with hepatic or renal dysfunction, organ...
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| Veröffentlicht in: | Journal of antimicrobial chemotherapy 2014-08, Vol.69 (8), p.2246-2251 |
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| creator | Kalita, J Misra, U K Prasad, S Bhoi, S K |
| description | We report the efficacy and safety of levofloxacin versus rifampicin in tuberculous meningitis (TBM).
In this open-label, randomized controlled trial from India, patients with TBM diagnosed on the basis of clinical, MRI and CSF findings were included. Patients with hepatic or renal dysfunction, organ transplantation, malignancy, pregnancy, lactation, allergy, seizure, age |
| doi_str_mv | 10.1093/jac/dku103 |
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| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_1548251969</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3383810251</sourcerecordid><originalsourceid>FETCH-LOGICAL-c351t-d4bb2336a07fad8218ccab1c4e58a530ffbd3b5d9e9287f67f6b3b11b1139853</originalsourceid><addsrcrecordid>eNo9kF1LwzAUhoMobk5v_AES8E6oS5qmbbyT4RcMvHD3JZ-SmTY1aYfbrzdjU3jhHJKX58ADwDVG9xgxMl9zOVdfI0bkBExxUaIsRwyfgikiiGZVQckEXMS4RgiVtKzPwSQvKpozWk3B7oMbPWwh7xTUxljJ5RZ6A53eeOP8D5e2gxsd4hhhsIa3vd2_pAyj0EGOzqefVne2-7SDjQ-JBH2vu8xxoR0MCexbu9MKSt8NwTuX1iFY7i7BmeEu6qvjnIHV89Nq8Zot31_eFo_LTBKKh0wVQuSElBxVhqs6x7WUXGBZaFpzSpAxQhFBFdMsrytTpggiME4hrKZkBm4P2D7471HHoVn7MXTpYoNpUecUs5Kl1t2hJYOPMWjT9MG2PGwbjJq95SZZbg6WU_nmiBxFq9V_9U8r-QUz4XvO</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1548251969</pqid></control><display><type>article</type><title>Safety and efficacy of levofloxacin versus rifampicin in tuberculous meningitis: an open-label randomized controlled trial</title><source>MEDLINE</source><source>Oxford Journals Online</source><source>Alma/SFX Local Collection</source><source>Free Full-Text Journals in Chemistry</source><source>EZB Electronic Journals Library</source><creator>Kalita, J ; Misra, U K ; Prasad, S ; Bhoi, S K</creator><creatorcontrib>Kalita, J ; Misra, U K ; Prasad, S ; Bhoi, S K</creatorcontrib><description>We report the efficacy and safety of levofloxacin versus rifampicin in tuberculous meningitis (TBM).
In this open-label, randomized controlled trial from India, patients with TBM diagnosed on the basis of clinical, MRI and CSF findings were included. Patients with hepatic or renal dysfunction, organ transplantation, malignancy, pregnancy, lactation, allergy, seizure, age <15 years and antitubercular treatment ≥1 month were excluded. Sixty patients each were randomized to levofloxacin (10 mg/kg, maximum 500 mg) or rifampicin (10 mg/kg, maximum 450 mg). They also received isoniazid, pyrazinamide, ethambutol, prednisolone and aspirin. The primary outcome was death and secondary outcome measures were 6 month disability, repeat MRI changes and serious adverse events (SAEs).
The median age of the patients was 34.5 (16-75) years. The baseline clinical and MRI findings were similar between the two groups. At 6 months, 13 out of 60 (21.7%) patients in the levofloxacin arm and 23 out of 60 (38.3%) patients in the rifampicin arm had died (P = 0.07). On Cox regression analysis, survival in the levofloxacin group was significantly better than in the rifampicin group (hazard ratio 2.13, 95% CI 1.04-4.34, P = 0.04). The functional outcome (P = 0.47) was, however, not significantly different between the two groups. On intention-to-treat analysis, 10 out of 47 (21.3%) in the levofloxacin arm and 5 out of 37 (13.5%) in the rifampicin arm had poor recovery. Repeat MRI findings did not differ between the groups. Levofloxacin was discontinued more frequently than rifampicin due to SAEs (16 versus 4, P = 0.01).
Levofloxacin is superior to rifampicin in reducing 6 month death in TBM but not disability. Levofloxacin may be used in TBM especially in those patients with hepatotoxicity and without seizure.</description><identifier>ISSN: 0305-7453</identifier><identifier>EISSN: 1460-2091</identifier><identifier>DOI: 10.1093/jac/dku103</identifier><identifier>PMID: 24752957</identifier><language>eng</language><publisher>England: Oxford Publishing Limited (England)</publisher><subject>Adolescent ; Adult ; Aged ; Antitubercular Agents - therapeutic use ; Aspirin - therapeutic use ; Clinical outcomes ; Cortisone ; Drug Therapy, Combination ; Ethambutol - therapeutic use ; Female ; Humans ; Isoniazid - therapeutic use ; Levofloxacin - adverse effects ; Levofloxacin - therapeutic use ; Male ; Medical prognosis ; Meningitis ; Middle Aged ; NMR ; Nuclear magnetic resonance ; Prednisolone - therapeutic use ; Pyrazinamide - therapeutic use ; Radiography ; Rifampin - adverse effects ; Rifampin - therapeutic use ; Treatment Outcome ; Tuberculosis, Meningeal - diagnostic imaging ; Tuberculosis, Meningeal - drug therapy ; Tuberculosis, Meningeal - mortality ; Young Adult</subject><ispartof>Journal of antimicrobial chemotherapy, 2014-08, Vol.69 (8), p.2246-2251</ispartof><rights>The Author 2014. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.</rights><rights>Copyright Oxford Publishing Limited(England) Aug 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c351t-d4bb2336a07fad8218ccab1c4e58a530ffbd3b5d9e9287f67f6b3b11b1139853</citedby><cites>FETCH-LOGICAL-c351t-d4bb2336a07fad8218ccab1c4e58a530ffbd3b5d9e9287f67f6b3b11b1139853</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24752957$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kalita, J</creatorcontrib><creatorcontrib>Misra, U K</creatorcontrib><creatorcontrib>Prasad, S</creatorcontrib><creatorcontrib>Bhoi, S K</creatorcontrib><title>Safety and efficacy of levofloxacin versus rifampicin in tuberculous meningitis: an open-label randomized controlled trial</title><title>Journal of antimicrobial chemotherapy</title><addtitle>J Antimicrob Chemother</addtitle><description>We report the efficacy and safety of levofloxacin versus rifampicin in tuberculous meningitis (TBM).
In this open-label, randomized controlled trial from India, patients with TBM diagnosed on the basis of clinical, MRI and CSF findings were included. Patients with hepatic or renal dysfunction, organ transplantation, malignancy, pregnancy, lactation, allergy, seizure, age <15 years and antitubercular treatment ≥1 month were excluded. Sixty patients each were randomized to levofloxacin (10 mg/kg, maximum 500 mg) or rifampicin (10 mg/kg, maximum 450 mg). They also received isoniazid, pyrazinamide, ethambutol, prednisolone and aspirin. The primary outcome was death and secondary outcome measures were 6 month disability, repeat MRI changes and serious adverse events (SAEs).
The median age of the patients was 34.5 (16-75) years. The baseline clinical and MRI findings were similar between the two groups. At 6 months, 13 out of 60 (21.7%) patients in the levofloxacin arm and 23 out of 60 (38.3%) patients in the rifampicin arm had died (P = 0.07). On Cox regression analysis, survival in the levofloxacin group was significantly better than in the rifampicin group (hazard ratio 2.13, 95% CI 1.04-4.34, P = 0.04). The functional outcome (P = 0.47) was, however, not significantly different between the two groups. On intention-to-treat analysis, 10 out of 47 (21.3%) in the levofloxacin arm and 5 out of 37 (13.5%) in the rifampicin arm had poor recovery. Repeat MRI findings did not differ between the groups. Levofloxacin was discontinued more frequently than rifampicin due to SAEs (16 versus 4, P = 0.01).
Levofloxacin is superior to rifampicin in reducing 6 month death in TBM but not disability. Levofloxacin may be used in TBM especially in those patients with hepatotoxicity and without seizure.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Antitubercular Agents - therapeutic use</subject><subject>Aspirin - therapeutic use</subject><subject>Clinical outcomes</subject><subject>Cortisone</subject><subject>Drug Therapy, Combination</subject><subject>Ethambutol - therapeutic use</subject><subject>Female</subject><subject>Humans</subject><subject>Isoniazid - therapeutic use</subject><subject>Levofloxacin - adverse effects</subject><subject>Levofloxacin - therapeutic use</subject><subject>Male</subject><subject>Medical prognosis</subject><subject>Meningitis</subject><subject>Middle Aged</subject><subject>NMR</subject><subject>Nuclear magnetic resonance</subject><subject>Prednisolone - therapeutic use</subject><subject>Pyrazinamide - therapeutic use</subject><subject>Radiography</subject><subject>Rifampin - adverse effects</subject><subject>Rifampin - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Tuberculosis, Meningeal - diagnostic imaging</subject><subject>Tuberculosis, Meningeal - drug therapy</subject><subject>Tuberculosis, Meningeal - mortality</subject><subject>Young Adult</subject><issn>0305-7453</issn><issn>1460-2091</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9kF1LwzAUhoMobk5v_AES8E6oS5qmbbyT4RcMvHD3JZ-SmTY1aYfbrzdjU3jhHJKX58ADwDVG9xgxMl9zOVdfI0bkBExxUaIsRwyfgikiiGZVQckEXMS4RgiVtKzPwSQvKpozWk3B7oMbPWwh7xTUxljJ5RZ6A53eeOP8D5e2gxsd4hhhsIa3vd2_pAyj0EGOzqefVne2-7SDjQ-JBH2vu8xxoR0MCexbu9MKSt8NwTuX1iFY7i7BmeEu6qvjnIHV89Nq8Zot31_eFo_LTBKKh0wVQuSElBxVhqs6x7WUXGBZaFpzSpAxQhFBFdMsrytTpggiME4hrKZkBm4P2D7471HHoVn7MXTpYoNpUecUs5Kl1t2hJYOPMWjT9MG2PGwbjJq95SZZbg6WU_nmiBxFq9V_9U8r-QUz4XvO</recordid><startdate>20140801</startdate><enddate>20140801</enddate><creator>Kalita, J</creator><creator>Misra, U K</creator><creator>Prasad, S</creator><creator>Bhoi, S K</creator><general>Oxford Publishing Limited (England)</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>7QL</scope><scope>7QO</scope><scope>7T7</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope></search><sort><creationdate>20140801</creationdate><title>Safety and efficacy of levofloxacin versus rifampicin in tuberculous meningitis: an open-label randomized controlled trial</title><author>Kalita, J ; Misra, U K ; Prasad, S ; Bhoi, S K</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c351t-d4bb2336a07fad8218ccab1c4e58a530ffbd3b5d9e9287f67f6b3b11b1139853</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Antitubercular Agents - therapeutic use</topic><topic>Aspirin - therapeutic use</topic><topic>Clinical outcomes</topic><topic>Cortisone</topic><topic>Drug Therapy, Combination</topic><topic>Ethambutol - therapeutic use</topic><topic>Female</topic><topic>Humans</topic><topic>Isoniazid - therapeutic use</topic><topic>Levofloxacin - adverse effects</topic><topic>Levofloxacin - therapeutic use</topic><topic>Male</topic><topic>Medical prognosis</topic><topic>Meningitis</topic><topic>Middle Aged</topic><topic>NMR</topic><topic>Nuclear magnetic resonance</topic><topic>Prednisolone - therapeutic use</topic><topic>Pyrazinamide - therapeutic use</topic><topic>Radiography</topic><topic>Rifampin - adverse effects</topic><topic>Rifampin - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Tuberculosis, Meningeal - diagnostic imaging</topic><topic>Tuberculosis, Meningeal - drug therapy</topic><topic>Tuberculosis, Meningeal - mortality</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kalita, J</creatorcontrib><creatorcontrib>Misra, U K</creatorcontrib><creatorcontrib>Prasad, S</creatorcontrib><creatorcontrib>Bhoi, S K</creatorcontrib><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>Biotechnology Research Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</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>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>Journal of antimicrobial chemotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kalita, J</au><au>Misra, U K</au><au>Prasad, S</au><au>Bhoi, S K</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and efficacy of levofloxacin versus rifampicin in tuberculous meningitis: an open-label randomized controlled trial</atitle><jtitle>Journal of antimicrobial chemotherapy</jtitle><addtitle>J Antimicrob Chemother</addtitle><date>2014-08-01</date><risdate>2014</risdate><volume>69</volume><issue>8</issue><spage>2246</spage><epage>2251</epage><pages>2246-2251</pages><issn>0305-7453</issn><eissn>1460-2091</eissn><abstract>We report the efficacy and safety of levofloxacin versus rifampicin in tuberculous meningitis (TBM).
In this open-label, randomized controlled trial from India, patients with TBM diagnosed on the basis of clinical, MRI and CSF findings were included. Patients with hepatic or renal dysfunction, organ transplantation, malignancy, pregnancy, lactation, allergy, seizure, age <15 years and antitubercular treatment ≥1 month were excluded. Sixty patients each were randomized to levofloxacin (10 mg/kg, maximum 500 mg) or rifampicin (10 mg/kg, maximum 450 mg). They also received isoniazid, pyrazinamide, ethambutol, prednisolone and aspirin. The primary outcome was death and secondary outcome measures were 6 month disability, repeat MRI changes and serious adverse events (SAEs).
The median age of the patients was 34.5 (16-75) years. The baseline clinical and MRI findings were similar between the two groups. At 6 months, 13 out of 60 (21.7%) patients in the levofloxacin arm and 23 out of 60 (38.3%) patients in the rifampicin arm had died (P = 0.07). On Cox regression analysis, survival in the levofloxacin group was significantly better than in the rifampicin group (hazard ratio 2.13, 95% CI 1.04-4.34, P = 0.04). The functional outcome (P = 0.47) was, however, not significantly different between the two groups. On intention-to-treat analysis, 10 out of 47 (21.3%) in the levofloxacin arm and 5 out of 37 (13.5%) in the rifampicin arm had poor recovery. Repeat MRI findings did not differ between the groups. Levofloxacin was discontinued more frequently than rifampicin due to SAEs (16 versus 4, P = 0.01).
Levofloxacin is superior to rifampicin in reducing 6 month death in TBM but not disability. Levofloxacin may be used in TBM especially in those patients with hepatotoxicity and without seizure.</abstract><cop>England</cop><pub>Oxford Publishing Limited (England)</pub><pmid>24752957</pmid><doi>10.1093/jac/dku103</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Oxford Journals Online; Alma/SFX Local Collection; Free Full-Text Journals in Chemistry; EZB Electronic Journals Library |
| subjects | Adolescent Adult Aged Antitubercular Agents - therapeutic use Aspirin - therapeutic use Clinical outcomes Cortisone Drug Therapy, Combination Ethambutol - therapeutic use Female Humans Isoniazid - therapeutic use Levofloxacin - adverse effects Levofloxacin - therapeutic use Male Medical prognosis Meningitis Middle Aged NMR Nuclear magnetic resonance Prednisolone - therapeutic use Pyrazinamide - therapeutic use Radiography Rifampin - adverse effects Rifampin - therapeutic use Treatment Outcome Tuberculosis, Meningeal - diagnostic imaging Tuberculosis, Meningeal - drug therapy Tuberculosis, Meningeal - mortality Young Adult |
| title | Safety and efficacy of levofloxacin versus rifampicin in tuberculous meningitis: an open-label randomized controlled trial |
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