Pharmacokinetics, Safety, and Biologic Effects of Azithromycin in Extremely Preterm Infants at Risk for Ureaplasma Colonization and Bronchopulmonary Dysplasia
Ureaplasma spp. respiratory tract colonization is a significant risk factor for bronchopulmonary dysplasia (BPD), a chronic lung disorder in preterm infants. As an initial step preparatory to future clinical trials to evaluate the clinical efficacy of azithromycin to prevent BPD, the authors charact...
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| Veröffentlicht in: | Journal of clinical pharmacology 2011-09, Vol.51 (9), p.1264-1275 |
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| creator | Hassan, Hazem E. Othman, Ahmed A. Eddington, Natalie D. Duffy, Lynn Xiao, Li Waites, Ken B. Kaufman, David A. Fairchild, Karen D. MD, Michael L. Terrin Viscardi, Rose M. |
| description | Ureaplasma spp. respiratory tract colonization is a significant risk factor for bronchopulmonary dysplasia (BPD), a chronic lung disorder in preterm infants. As an initial step preparatory to future clinical trials to evaluate the clinical efficacy of azithromycin to prevent BPD, the authors characterized the pharmacokinetics, safety, and biological effects of a single intravenous dose of azithromycin (10 mg/kg) in preterm neonates (n = 12) 24 to 28 weeks gestation at risk for Ureaplasma infection and BPD. A 2‐compartment structural model with the clearance and volume of peripheral compartment (V2) allometrically scaled on body weight (WT) best described the pharmacokinetics of azithromycin in preterm neonates. The estimated parameters were clearance [0.18 L/h × WT(kg)0.75], inter‐compartmental clearance [1.0 L/h], volume of distribution of central compartment [0.93 L], and V2 [14.2 L × WT(kg)]. There were no serious adverse events attributed to azithromycin. A single dose of azithromycin did not suppress inflammatory cytokines or myeloperoxidase activity in tracheal aspirates. These results demonstrated the safety of azithromycin and developed a pharmacokinetic model that is useful for future simulation‐based clinical trials for eradicating Ureaplasma and preventing BPD in preterm neonates. |
| doi_str_mv | 10.1177/0091270010382021 |
| format | Article |
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Terrin ; Viscardi, Rose M.</creator><creatorcontrib>Hassan, Hazem E. ; Othman, Ahmed A. ; Eddington, Natalie D. ; Duffy, Lynn ; Xiao, Li ; Waites, Ken B. ; Kaufman, David A. ; Fairchild, Karen D. ; MD, Michael L. Terrin ; Viscardi, Rose M.</creatorcontrib><description>Ureaplasma spp. respiratory tract colonization is a significant risk factor for bronchopulmonary dysplasia (BPD), a chronic lung disorder in preterm infants. As an initial step preparatory to future clinical trials to evaluate the clinical efficacy of azithromycin to prevent BPD, the authors characterized the pharmacokinetics, safety, and biological effects of a single intravenous dose of azithromycin (10 mg/kg) in preterm neonates (n = 12) 24 to 28 weeks gestation at risk for Ureaplasma infection and BPD. A 2‐compartment structural model with the clearance and volume of peripheral compartment (V2) allometrically scaled on body weight (WT) best described the pharmacokinetics of azithromycin in preterm neonates. The estimated parameters were clearance [0.18 L/h × WT(kg)0.75], inter‐compartmental clearance [1.0 L/h], volume of distribution of central compartment [0.93 L], and V2 [14.2 L × WT(kg)]. There were no serious adverse events attributed to azithromycin. A single dose of azithromycin did not suppress inflammatory cytokines or myeloperoxidase activity in tracheal aspirates. These results demonstrated the safety of azithromycin and developed a pharmacokinetic model that is useful for future simulation‐based clinical trials for eradicating Ureaplasma and preventing BPD in preterm neonates.</description><identifier>ISSN: 0091-2700</identifier><identifier>EISSN: 1552-4604</identifier><identifier>DOI: 10.1177/0091270010382021</identifier><identifier>PMID: 21098694</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Azithromycin ; Azithromycin - adverse effects ; Azithromycin - pharmacokinetics ; Azithromycin - therapeutic use ; bronchopulmonary dysplasia ; Bronchopulmonary Dysplasia - drug therapy ; Bronchopulmonary Dysplasia - metabolism ; Female ; Humans ; Infant, Extremely Low Birth Weight - metabolism ; Infant, Newborn ; Infant, Premature ; Infant, Premature, Diseases - drug therapy ; Infant, Premature, Diseases - metabolism ; Male ; pharmacokinetics ; prematurity ; Respiration, Artificial - adverse effects ; Ureaplasma ; Ureaplasma - drug effects ; Ureaplasma - isolation & purification ; Ureaplasma Infections - diagnosis ; Ureaplasma Infections - drug therapy ; Ureaplasma Infections - metabolism</subject><ispartof>Journal of clinical pharmacology, 2011-09, Vol.51 (9), p.1264-1275</ispartof><rights>2011 American College of Clinical Pharmacology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5087-3647bb279c9b0e41be42513e2c456d7dc87ab3f3c00f047d0a8250e3d82d77e13</citedby><cites>FETCH-LOGICAL-c5087-3647bb279c9b0e41be42513e2c456d7dc87ab3f3c00f047d0a8250e3d82d77e13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1177%2F0091270010382021$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1177%2F0091270010382021$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,776,780,881,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21098694$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hassan, Hazem E.</creatorcontrib><creatorcontrib>Othman, Ahmed A.</creatorcontrib><creatorcontrib>Eddington, Natalie D.</creatorcontrib><creatorcontrib>Duffy, Lynn</creatorcontrib><creatorcontrib>Xiao, Li</creatorcontrib><creatorcontrib>Waites, Ken B.</creatorcontrib><creatorcontrib>Kaufman, David A.</creatorcontrib><creatorcontrib>Fairchild, Karen D.</creatorcontrib><creatorcontrib>MD, Michael L. Terrin</creatorcontrib><creatorcontrib>Viscardi, Rose M.</creatorcontrib><title>Pharmacokinetics, Safety, and Biologic Effects of Azithromycin in Extremely Preterm Infants at Risk for Ureaplasma Colonization and Bronchopulmonary Dysplasia</title><title>Journal of clinical pharmacology</title><addtitle>J Clin Pharmacol</addtitle><description>Ureaplasma spp. respiratory tract colonization is a significant risk factor for bronchopulmonary dysplasia (BPD), a chronic lung disorder in preterm infants. As an initial step preparatory to future clinical trials to evaluate the clinical efficacy of azithromycin to prevent BPD, the authors characterized the pharmacokinetics, safety, and biological effects of a single intravenous dose of azithromycin (10 mg/kg) in preterm neonates (n = 12) 24 to 28 weeks gestation at risk for Ureaplasma infection and BPD. A 2‐compartment structural model with the clearance and volume of peripheral compartment (V2) allometrically scaled on body weight (WT) best described the pharmacokinetics of azithromycin in preterm neonates. The estimated parameters were clearance [0.18 L/h × WT(kg)0.75], inter‐compartmental clearance [1.0 L/h], volume of distribution of central compartment [0.93 L], and V2 [14.2 L × WT(kg)]. There were no serious adverse events attributed to azithromycin. A single dose of azithromycin did not suppress inflammatory cytokines or myeloperoxidase activity in tracheal aspirates. These results demonstrated the safety of azithromycin and developed a pharmacokinetic model that is useful for future simulation‐based clinical trials for eradicating Ureaplasma and preventing BPD in preterm neonates.</description><subject>Azithromycin</subject><subject>Azithromycin - adverse effects</subject><subject>Azithromycin - pharmacokinetics</subject><subject>Azithromycin - therapeutic use</subject><subject>bronchopulmonary dysplasia</subject><subject>Bronchopulmonary Dysplasia - drug therapy</subject><subject>Bronchopulmonary Dysplasia - metabolism</subject><subject>Female</subject><subject>Humans</subject><subject>Infant, Extremely Low Birth Weight - metabolism</subject><subject>Infant, Newborn</subject><subject>Infant, Premature</subject><subject>Infant, Premature, Diseases - drug therapy</subject><subject>Infant, Premature, Diseases - metabolism</subject><subject>Male</subject><subject>pharmacokinetics</subject><subject>prematurity</subject><subject>Respiration, Artificial - adverse effects</subject><subject>Ureaplasma</subject><subject>Ureaplasma - drug effects</subject><subject>Ureaplasma - isolation & purification</subject><subject>Ureaplasma Infections - diagnosis</subject><subject>Ureaplasma Infections - drug therapy</subject><subject>Ureaplasma Infections - metabolism</subject><issn>0091-2700</issn><issn>1552-4604</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkU9v0zAYxi0EYmVw54QscV3Aduw4uSCNULqhCSJg6tFyHGf1mtjFdrdlH4bPSqKMCrggWfLh_T1_pAeAlxi9wZjztwgVmHCEMEpzggh-BBaYMZLQDNHHYDGdk-l-BJ6FcD1yGWX4KTgiGBV5VtAF-FltpO-lcltjdTQqnMBvstVxOIHSNvC9cZ27Mgou21arGKBr4em9iRvv-kEZC8e3vIte97obYOV11L6H57aVdoRlhF9N2MLWeXjptdx1MvQSlqOnNfcyGmfnFO-s2rjdvuudlX6AH4YwsUY-B09a2QX94uE_Bpcfl9_Ls-Tiy-q8PL1IFEM5T9KM8romvFBFjTTFtaaE4VQTRVnW8EblXNZpmyqEWkR5g2ROGNJpk5OGc43TY_Bu9t3t6143StvoZSd23vRjH-GkEX9frNmIK3cjKKGIUzYavH4w8O7HXocort3e27GzwBxlGScpm2LQTCnvQvC6PSRgJKZFxb-LjpJXfzY7CH5POALZDNyaTg__NRSfyuqMUcpHYTILTYj67iCUfisynnIm1p9Xgq2rcsWqUqzTX5VcvWc</recordid><startdate>201109</startdate><enddate>201109</enddate><creator>Hassan, Hazem E.</creator><creator>Othman, Ahmed A.</creator><creator>Eddington, Natalie D.</creator><creator>Duffy, Lynn</creator><creator>Xiao, Li</creator><creator>Waites, Ken B.</creator><creator>Kaufman, David A.</creator><creator>Fairchild, Karen D.</creator><creator>MD, Michael L. Terrin</creator><creator>Viscardi, Rose M.</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</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>7QP</scope><scope>7QR</scope><scope>7T5</scope><scope>7TK</scope><scope>7TM</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>5PM</scope></search><sort><creationdate>201109</creationdate><title>Pharmacokinetics, Safety, and Biologic Effects of Azithromycin in Extremely Preterm Infants at Risk for Ureaplasma Colonization and Bronchopulmonary Dysplasia</title><author>Hassan, Hazem E. ; Othman, Ahmed A. ; Eddington, Natalie D. ; Duffy, Lynn ; Xiao, Li ; Waites, Ken B. ; Kaufman, David A. ; Fairchild, Karen D. ; MD, Michael L. 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Terrin</au><au>Viscardi, Rose M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmacokinetics, Safety, and Biologic Effects of Azithromycin in Extremely Preterm Infants at Risk for Ureaplasma Colonization and Bronchopulmonary Dysplasia</atitle><jtitle>Journal of clinical pharmacology</jtitle><addtitle>J Clin Pharmacol</addtitle><date>2011-09</date><risdate>2011</risdate><volume>51</volume><issue>9</issue><spage>1264</spage><epage>1275</epage><pages>1264-1275</pages><issn>0091-2700</issn><eissn>1552-4604</eissn><abstract>Ureaplasma spp. respiratory tract colonization is a significant risk factor for bronchopulmonary dysplasia (BPD), a chronic lung disorder in preterm infants. As an initial step preparatory to future clinical trials to evaluate the clinical efficacy of azithromycin to prevent BPD, the authors characterized the pharmacokinetics, safety, and biological effects of a single intravenous dose of azithromycin (10 mg/kg) in preterm neonates (n = 12) 24 to 28 weeks gestation at risk for Ureaplasma infection and BPD. A 2‐compartment structural model with the clearance and volume of peripheral compartment (V2) allometrically scaled on body weight (WT) best described the pharmacokinetics of azithromycin in preterm neonates. The estimated parameters were clearance [0.18 L/h × WT(kg)0.75], inter‐compartmental clearance [1.0 L/h], volume of distribution of central compartment [0.93 L], and V2 [14.2 L × WT(kg)]. There were no serious adverse events attributed to azithromycin. A single dose of azithromycin did not suppress inflammatory cytokines or myeloperoxidase activity in tracheal aspirates. These results demonstrated the safety of azithromycin and developed a pharmacokinetic model that is useful for future simulation‐based clinical trials for eradicating Ureaplasma and preventing BPD in preterm neonates.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>21098694</pmid><doi>10.1177/0091270010382021</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Azithromycin Azithromycin - adverse effects Azithromycin - pharmacokinetics Azithromycin - therapeutic use bronchopulmonary dysplasia Bronchopulmonary Dysplasia - drug therapy Bronchopulmonary Dysplasia - metabolism Female Humans Infant, Extremely Low Birth Weight - metabolism Infant, Newborn Infant, Premature Infant, Premature, Diseases - drug therapy Infant, Premature, Diseases - metabolism Male pharmacokinetics prematurity Respiration, Artificial - adverse effects Ureaplasma Ureaplasma - drug effects Ureaplasma - isolation & purification Ureaplasma Infections - diagnosis Ureaplasma Infections - drug therapy Ureaplasma Infections - metabolism |
| title | Pharmacokinetics, Safety, and Biologic Effects of Azithromycin in Extremely Preterm Infants at Risk for Ureaplasma Colonization and Bronchopulmonary Dysplasia |
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