Rifampin Pharmacokinetics and Safety in Preterm and Term Infants
Rifampin is active against methicillin-resistant staphylococcal species and tuberculosis (TB). We performed a multicenter, prospective pharmacokinetic (PK) and safety study of intravenous rifampin in infants of
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| Veröffentlicht in: | Antimicrobial agents and chemotherapy 2019-06, Vol.63 (6) |
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| container_title | Antimicrobial agents and chemotherapy |
| container_volume | 63 |
| creator | Smith, P Brian Cotten, C Michael Hudak, Mark L Sullivan, Janice E Poindexter, Brenda B Cohen-Wolkowiez, Michael Boakye-Agyeman, Felix Lewandowski, Andrew Anand, Ravinder Benjamin, Jr, Daniel K Laughon, Matthew M |
| description | Rifampin is active against methicillin-resistant staphylococcal species and tuberculosis (TB). We performed a multicenter, prospective pharmacokinetic (PK) and safety study of intravenous rifampin in infants of |
| doi_str_mv | 10.1128/AAC.00284-19 |
| format | Article |
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We performed a multicenter, prospective pharmacokinetic (PK) and safety study of intravenous rifampin in infants of <121 days postnatal age (PNA). We enrolled 27 infants; the median (range) gestational age was 26 weeks (23 to 41 weeks), and the median PNA was 10 days (0 to 84 days). We collected 102 plasma PK samples from 22 of the infants and analyzed safety data from all 27 infants. We analyzed the data using a population PK approach. Rifampin PK was best characterized by a one-compartment model; drug clearance increased with increasing size (body weight) and maturation (PNA). There were no adverse events related to rifampin. Simulated weight and PNA-based intravenous dosing regimens administered once daily (<14 days PNA, 8 mg/kg; ≥14 days PNA, 15 mg/kg) in infants resulted in comparable exposures to adults receiving therapeutic doses of rifampin against staphylococcal infections and TB. (This study has been registered at ClinicalTrials.gov under identifier NCT01728363.).</description><identifier>ISSN: 0066-4804</identifier><identifier>ISSN: 1098-6596</identifier><identifier>EISSN: 1098-6596</identifier><identifier>DOI: 10.1128/AAC.00284-19</identifier><identifier>PMID: 30910891</identifier><language>eng</language><publisher>United States: American Society for Microbiology</publisher><subject>Female ; Gestational Age ; Humans ; Infant ; Infant, Newborn ; Infant, Premature ; Infant, Premature - metabolism ; Male ; Pharmacology ; Prospective Studies ; Rifampin ; Rifampin - adverse effects ; Rifampin - pharmacokinetics ; Rifampin - therapeutic use ; Staphylococcal Infections - drug therapy ; Staphylococcal Infections - metabolism ; Tuberculosis - drug therapy ; Tuberculosis - metabolism</subject><ispartof>Antimicrobial agents and chemotherapy, 2019-06, Vol.63 (6)</ispartof><rights>Copyright © 2019 American Society for Microbiology.</rights><rights>Copyright © 2019 American Society for Microbiology. 2019 American Society for Microbiology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-a418t-b48645747c53ead0161e3ad15662b6152c76f4e9f87234b776840ae2b314fe8b3</citedby><cites>FETCH-LOGICAL-a418t-b48645747c53ead0161e3ad15662b6152c76f4e9f87234b776840ae2b314fe8b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6535522/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6535522/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,724,777,781,882,27905,27906,53772,53774</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30910891$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Smith, P Brian</creatorcontrib><creatorcontrib>Cotten, C Michael</creatorcontrib><creatorcontrib>Hudak, Mark L</creatorcontrib><creatorcontrib>Sullivan, Janice E</creatorcontrib><creatorcontrib>Poindexter, Brenda B</creatorcontrib><creatorcontrib>Cohen-Wolkowiez, Michael</creatorcontrib><creatorcontrib>Boakye-Agyeman, Felix</creatorcontrib><creatorcontrib>Lewandowski, Andrew</creatorcontrib><creatorcontrib>Anand, Ravinder</creatorcontrib><creatorcontrib>Benjamin, Jr, Daniel K</creatorcontrib><creatorcontrib>Laughon, Matthew M</creatorcontrib><creatorcontrib>Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee</creatorcontrib><creatorcontrib>on behalf of the Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee</creatorcontrib><title>Rifampin Pharmacokinetics and Safety in Preterm and Term Infants</title><title>Antimicrobial agents and chemotherapy</title><addtitle>Antimicrob Agents Chemother</addtitle><addtitle>Antimicrob Agents Chemother</addtitle><description>Rifampin is active against methicillin-resistant staphylococcal species and tuberculosis (TB). We performed a multicenter, prospective pharmacokinetic (PK) and safety study of intravenous rifampin in infants of <121 days postnatal age (PNA). We enrolled 27 infants; the median (range) gestational age was 26 weeks (23 to 41 weeks), and the median PNA was 10 days (0 to 84 days). We collected 102 plasma PK samples from 22 of the infants and analyzed safety data from all 27 infants. We analyzed the data using a population PK approach. Rifampin PK was best characterized by a one-compartment model; drug clearance increased with increasing size (body weight) and maturation (PNA). There were no adverse events related to rifampin. Simulated weight and PNA-based intravenous dosing regimens administered once daily (<14 days PNA, 8 mg/kg; ≥14 days PNA, 15 mg/kg) in infants resulted in comparable exposures to adults receiving therapeutic doses of rifampin against staphylococcal infections and TB. (This study has been registered at ClinicalTrials.gov under identifier NCT01728363.).</description><subject>Female</subject><subject>Gestational Age</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Infant, Premature</subject><subject>Infant, Premature - metabolism</subject><subject>Male</subject><subject>Pharmacology</subject><subject>Prospective Studies</subject><subject>Rifampin</subject><subject>Rifampin - adverse effects</subject><subject>Rifampin - pharmacokinetics</subject><subject>Rifampin - therapeutic use</subject><subject>Staphylococcal Infections - drug therapy</subject><subject>Staphylococcal Infections - metabolism</subject><subject>Tuberculosis - drug therapy</subject><subject>Tuberculosis - metabolism</subject><issn>0066-4804</issn><issn>1098-6596</issn><issn>1098-6596</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc9LwzAUx4Mobk5vnqVHBTvz0iRNLuIY_hgMFJ3nkLap62zTmbTC_nu7H4oePOUl78P3kc9D6BTwEICIq9FoPMSYCBqC3EN9wFKEnEm-j_oYcx5SgWkPHXm_wN2dSXyIehGWgIWEPrp5LnJdLQsbPM21q3RavxfWNEXqA22z4EXnplkF67YzjXHV5nW2LiY217bxx-gg16U3J7tzgF7vbmfjh3D6eD8Zj6ahpiCaMKGCUxbTOGWR0RkGDibSGTDOScKBkTTmOTUyFzGJaBLHXFCsDUkioLkRSTRA19vcZZtUJkuNbZwu1dIVlXYrVetC_e3YYq7e6k_FWcQYIV3A-S7A1R-t8Y2qCp-astTW1K1XBGTcKREAHXq5RVNXe-9M_jMGsFpLV510tZGuQHb4xRbXviJqUbfOdib-Y89-f-Mn-Hsj0ReKT4iU</recordid><startdate>20190601</startdate><enddate>20190601</enddate><creator>Smith, P Brian</creator><creator>Cotten, C Michael</creator><creator>Hudak, Mark L</creator><creator>Sullivan, Janice E</creator><creator>Poindexter, Brenda B</creator><creator>Cohen-Wolkowiez, Michael</creator><creator>Boakye-Agyeman, Felix</creator><creator>Lewandowski, Andrew</creator><creator>Anand, Ravinder</creator><creator>Benjamin, Jr, Daniel K</creator><creator>Laughon, Matthew M</creator><general>American Society for Microbiology</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>7X8</scope><scope>5PM</scope></search><sort><creationdate>20190601</creationdate><title>Rifampin Pharmacokinetics and Safety in Preterm and Term Infants</title><author>Smith, P Brian ; Cotten, C Michael ; Hudak, Mark L ; Sullivan, Janice E ; Poindexter, Brenda B ; Cohen-Wolkowiez, Michael ; Boakye-Agyeman, Felix ; Lewandowski, Andrew ; Anand, Ravinder ; Benjamin, Jr, Daniel K ; Laughon, Matthew M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a418t-b48645747c53ead0161e3ad15662b6152c76f4e9f87234b776840ae2b314fe8b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Female</topic><topic>Gestational Age</topic><topic>Humans</topic><topic>Infant</topic><topic>Infant, Newborn</topic><topic>Infant, Premature</topic><topic>Infant, Premature - metabolism</topic><topic>Male</topic><topic>Pharmacology</topic><topic>Prospective Studies</topic><topic>Rifampin</topic><topic>Rifampin - adverse effects</topic><topic>Rifampin - pharmacokinetics</topic><topic>Rifampin - therapeutic use</topic><topic>Staphylococcal Infections - drug therapy</topic><topic>Staphylococcal Infections - metabolism</topic><topic>Tuberculosis - drug therapy</topic><topic>Tuberculosis - metabolism</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Smith, P Brian</creatorcontrib><creatorcontrib>Cotten, C Michael</creatorcontrib><creatorcontrib>Hudak, Mark L</creatorcontrib><creatorcontrib>Sullivan, Janice E</creatorcontrib><creatorcontrib>Poindexter, Brenda B</creatorcontrib><creatorcontrib>Cohen-Wolkowiez, Michael</creatorcontrib><creatorcontrib>Boakye-Agyeman, Felix</creatorcontrib><creatorcontrib>Lewandowski, Andrew</creatorcontrib><creatorcontrib>Anand, Ravinder</creatorcontrib><creatorcontrib>Benjamin, Jr, Daniel K</creatorcontrib><creatorcontrib>Laughon, Matthew M</creatorcontrib><creatorcontrib>Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee</creatorcontrib><creatorcontrib>on behalf of the Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Antimicrobial agents and chemotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Smith, P Brian</au><au>Cotten, C Michael</au><au>Hudak, Mark L</au><au>Sullivan, Janice E</au><au>Poindexter, Brenda B</au><au>Cohen-Wolkowiez, Michael</au><au>Boakye-Agyeman, Felix</au><au>Lewandowski, Andrew</au><au>Anand, Ravinder</au><au>Benjamin, Jr, Daniel K</au><au>Laughon, Matthew M</au><aucorp>Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee</aucorp><aucorp>on behalf of the Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Rifampin Pharmacokinetics and Safety in Preterm and Term Infants</atitle><jtitle>Antimicrobial agents and chemotherapy</jtitle><stitle>Antimicrob Agents Chemother</stitle><addtitle>Antimicrob Agents Chemother</addtitle><date>2019-06-01</date><risdate>2019</risdate><volume>63</volume><issue>6</issue><issn>0066-4804</issn><issn>1098-6596</issn><eissn>1098-6596</eissn><abstract>Rifampin is active against methicillin-resistant staphylococcal species and tuberculosis (TB). We performed a multicenter, prospective pharmacokinetic (PK) and safety study of intravenous rifampin in infants of <121 days postnatal age (PNA). We enrolled 27 infants; the median (range) gestational age was 26 weeks (23 to 41 weeks), and the median PNA was 10 days (0 to 84 days). We collected 102 plasma PK samples from 22 of the infants and analyzed safety data from all 27 infants. We analyzed the data using a population PK approach. Rifampin PK was best characterized by a one-compartment model; drug clearance increased with increasing size (body weight) and maturation (PNA). There were no adverse events related to rifampin. Simulated weight and PNA-based intravenous dosing regimens administered once daily (<14 days PNA, 8 mg/kg; ≥14 days PNA, 15 mg/kg) in infants resulted in comparable exposures to adults receiving therapeutic doses of rifampin against staphylococcal infections and TB. (This study has been registered at ClinicalTrials.gov under identifier NCT01728363.).</abstract><cop>United States</cop><pub>American Society for Microbiology</pub><pmid>30910891</pmid><doi>10.1128/AAC.00284-19</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Female Gestational Age Humans Infant Infant, Newborn Infant, Premature Infant, Premature - metabolism Male Pharmacology Prospective Studies Rifampin Rifampin - adverse effects Rifampin - pharmacokinetics Rifampin - therapeutic use Staphylococcal Infections - drug therapy Staphylococcal Infections - metabolism Tuberculosis - drug therapy Tuberculosis - metabolism |
| title | Rifampin Pharmacokinetics and Safety in Preterm and Term Infants |
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