Once-weekly liposomal amphotericin B as Candida prophylaxis in very low birth weight premature infants: A prospective, randomized, open-label, placebo-controlled pilot study
Abstract Objective: This study was conducted to evaluate once-weekly liposomal amphotericin B (L-AmB) for Candida prophylaxis in very low birth weight (VLBW) neonates. Methods: This prospective, randomized, open-label, placebo-controlled study included neonates who were
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| Veröffentlicht in: | Clinical therapeutics 2010-02, Vol.32 (2), p.265-271 |
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| creator | Arrieta, Antonio C., MD Shea, Kathy, BA Dhar, Vijay, MD Cleary, John P., MD Kukreja, Sudeep, MD Morris, Mindy, RNP Vargas-Shiraishi, Ofelia M., MS Ashouri, Negar, MD Singh, Jasjit, MD |
| description | Abstract Objective: This study was conducted to evaluate once-weekly liposomal amphotericin B (L-AmB) for Candida prophylaxis in very low birth weight (VLBW) neonates. Methods: This prospective, randomized, open-label, placebo-controlled study included neonates who were |
| doi_str_mv | 10.1016/j.clinthera.2010.02.016 |
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| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_733106340</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>1_s2_0_S0149291810000676</els_id><sourcerecordid>2734245441</sourcerecordid><originalsourceid>FETCH-LOGICAL-c483t-cfea8858be18a271c1c556064ebc7e2ce34158b0b2865227d6dda046538935b03</originalsourceid><addsrcrecordid>eNqNktuO0zAQhiMEYpeFVwBLCHHTFB9yKhdIpeIkrbQXgMSd5dhT6q4TZ22npbwT78hELbvSXnFjS-Pvn_yZf7LsBaNzRln1ZjvXzvZpA0HNOcUq5XOsP8jOWVMvcsaKHw-zc8qKRc4XrDnLnsS4pZSKRckfZ2ecclrVTXGe_bnqNeR7gGt3IM4OPvpOOaK6YeMTBKttT94TFclK9cYaRYbgh83BqV82EnzbQUCd35PWhrQhe7A_Nwkh6FQaAyCyVn2Kb8lyUsYBdLI7mJGA7Xxnf4OZET9AnzvVgpuRwSkNrc-171PwzoEhg3U-kZhGc3iaPVorF-HZ6b7Ivn_88G31Ob-8-vRltbzMddGIlOs1qKYpmxZYo3jNNNNlWdGqgFbXwDWIguErbXlTlZzXpjJG0aIqRbMQZUvFRfb62Bc934wQk-xs1OCc6sGPUdZCMFqJYiJf3iO3fgw9mpOMIlXhyZCqj5TGGcQAazkE26lwQEhOgcqtvA1UToFKyiXWUfn81H9sOzC3un8JIvDqBKiolVvjYLWNdxwv67IWk9HlkQOc285CkFFbwPCNDRiKNN7-h5l393pMnMXPXsMB4t2fy4gC-XXav2n9GG4euq3EX_l52nU</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1033161031</pqid></control><display><type>article</type><title>Once-weekly liposomal amphotericin B as Candida prophylaxis in very low birth weight premature infants: A prospective, randomized, open-label, placebo-controlled pilot study</title><source>MEDLINE</source><source>ScienceDirect Journals (5 years ago - present)</source><source>ProQuest Central UK/Ireland</source><creator>Arrieta, Antonio C., MD ; Shea, Kathy, BA ; Dhar, Vijay, MD ; Cleary, John P., MD ; Kukreja, Sudeep, MD ; Morris, Mindy, RNP ; Vargas-Shiraishi, Ofelia M., MS ; Ashouri, Negar, MD ; Singh, Jasjit, MD</creator><creatorcontrib>Arrieta, Antonio C., MD ; Shea, Kathy, BA ; Dhar, Vijay, MD ; Cleary, John P., MD ; Kukreja, Sudeep, MD ; Morris, Mindy, RNP ; Vargas-Shiraishi, Ofelia M., MS ; Ashouri, Negar, MD ; Singh, Jasjit, MD</creatorcontrib><description>Abstract Objective: This study was conducted to evaluate once-weekly liposomal amphotericin B (L-AmB) for Candida prophylaxis in very low birth weight (VLBW) neonates. Methods: This prospective, randomized, open-label, placebo-controlled study included neonates who were <32 weeks’ gestational age, <7 days old, and weighing <1500 g at birth. Subjects were randomized to receive L-AmB 5 mg/kg per week or placebo (dextrose water) and were followed until 6 weeks of age. Surveillance cultures were obtained at baseline, at 72 hours, and weekly thereafter. Study drug was continued until 6 weeks after birth or the discontinuation of high-risk treatments and invasive devices, whichever occurred first. Blood cultures were obtained as clinically indicated. The primary end point was development of Candida colonization by 6 weeks’ postnatal age; secondary end points included development of invasive candidiasis and occurrence of treatment-related adverse events. Safety variables included renal and hepatic function tests, incidence of grade III–IV intraventricular hemorrhage (IVH) and necrotizing enterocolitis (NEC), and mortality. Results: Forty subjects were enrolled and randomized to receive L-AmB (12 males, 8 females; 50% white) or placebo (12 males, 8 females; 35% white). Subjects were evenly distributed by gestational age, age at enrollment, birth weight, race, and sex. Consent was withdrawn after completion of study treatment in 1 subject (L-AmB); 1 subject in each study arm died during the study; and 3 subjects were transferred back to their referring institutions (1 L-AmB, 2 placebo). Thus, 17 subjects in each arm completed all study procedures, although all 40 subjects were evaluable. Colonization before administration of study drug was noted in 4 L-AmB subjects (20%) and 1 placebo subject (5%); 1 (5%) and 3 (15%) subjects in the respective groups developed colonization while receiving study drug. No L-AmB subjects and 1 placebo subject developed candidiasis. One subject in each group died; these deaths were not considered related to study drug or fungal infection. There were no clinical differences between groups in the incidence of grade III–IV IVH, NEC, hypokalemia, nephrotoxicity, need for platelet or packed red blood cell transfusion, or mortality. Conclusions: L-AmB 5 mg/kg once weekly was generally well tolerated in these VLBW infants. The data did not allow evaluation of efficacy. A larger, multicenter, randomized clinical trial of L-AmB for Candida prophylaxis that is appropriately powered is warranted.</description><identifier>ISSN: 0149-2918</identifier><identifier>EISSN: 1879-114X</identifier><identifier>DOI: 10.1016/j.clinthera.2010.02.016</identifier><identifier>PMID: 20206784</identifier><language>eng</language><publisher>Bridgewater, NJ: EM Inc USA</publisher><subject>Amphotericin B - administration & dosage ; Amphotericin B - adverse effects ; Antifungal agents ; Antifungal Agents - administration & dosage ; Antifungal Agents - adverse effects ; Biological and medical sciences ; Birth weight ; Bone marrow ; Candida prophylaxis ; Candidiasis - diagnosis ; Candidiasis - etiology ; Candidiasis - prevention & control ; Children & youth ; Disease prevention ; Diseases of mother, fetus and pregnancy ; Drug Administration Schedule ; Female ; Fungal infections ; Gestational Age ; Gynecology. Andrology. Obstetrics ; Humans ; Infant, Newborn ; Infant, Premature ; Infant, Very Low Birth Weight ; Infectious diseases ; Intensive care ; Internal Medicine ; liposomal amphotericin B ; Male ; Medical Education ; Medical sciences ; Mortality ; neonates ; Pediatrics ; Pharmacokinetics ; Pharmacology. Drug treatments ; Pilot Projects ; Pregnancy. Fetus. Placenta ; Premature babies ; Premature birth ; Prospective Studies ; Stem cell transplantation ; Treatment Outcome</subject><ispartof>Clinical therapeutics, 2010-02, Vol.32 (2), p.265-271</ispartof><rights>2010</rights><rights>2015 INIST-CNRS</rights><rights>Copyright 2010. Published by EM Inc USA.</rights><rights>Copyright Elsevier Limited Feb 2010</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c483t-cfea8858be18a271c1c556064ebc7e2ce34158b0b2865227d6dda046538935b03</citedby><cites>FETCH-LOGICAL-c483t-cfea8858be18a271c1c556064ebc7e2ce34158b0b2865227d6dda046538935b03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1033161031?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995,64385,64387,64389,72469</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22575730$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20206784$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Arrieta, Antonio C., MD</creatorcontrib><creatorcontrib>Shea, Kathy, BA</creatorcontrib><creatorcontrib>Dhar, Vijay, MD</creatorcontrib><creatorcontrib>Cleary, John P., MD</creatorcontrib><creatorcontrib>Kukreja, Sudeep, MD</creatorcontrib><creatorcontrib>Morris, Mindy, RNP</creatorcontrib><creatorcontrib>Vargas-Shiraishi, Ofelia M., MS</creatorcontrib><creatorcontrib>Ashouri, Negar, MD</creatorcontrib><creatorcontrib>Singh, Jasjit, MD</creatorcontrib><title>Once-weekly liposomal amphotericin B as Candida prophylaxis in very low birth weight premature infants: A prospective, randomized, open-label, placebo-controlled pilot study</title><title>Clinical therapeutics</title><addtitle>Clin Ther</addtitle><description>Abstract Objective: This study was conducted to evaluate once-weekly liposomal amphotericin B (L-AmB) for Candida prophylaxis in very low birth weight (VLBW) neonates. Methods: This prospective, randomized, open-label, placebo-controlled study included neonates who were <32 weeks’ gestational age, <7 days old, and weighing <1500 g at birth. Subjects were randomized to receive L-AmB 5 mg/kg per week or placebo (dextrose water) and were followed until 6 weeks of age. Surveillance cultures were obtained at baseline, at 72 hours, and weekly thereafter. Study drug was continued until 6 weeks after birth or the discontinuation of high-risk treatments and invasive devices, whichever occurred first. Blood cultures were obtained as clinically indicated. The primary end point was development of Candida colonization by 6 weeks’ postnatal age; secondary end points included development of invasive candidiasis and occurrence of treatment-related adverse events. Safety variables included renal and hepatic function tests, incidence of grade III–IV intraventricular hemorrhage (IVH) and necrotizing enterocolitis (NEC), and mortality. Results: Forty subjects were enrolled and randomized to receive L-AmB (12 males, 8 females; 50% white) or placebo (12 males, 8 females; 35% white). Subjects were evenly distributed by gestational age, age at enrollment, birth weight, race, and sex. Consent was withdrawn after completion of study treatment in 1 subject (L-AmB); 1 subject in each study arm died during the study; and 3 subjects were transferred back to their referring institutions (1 L-AmB, 2 placebo). Thus, 17 subjects in each arm completed all study procedures, although all 40 subjects were evaluable. Colonization before administration of study drug was noted in 4 L-AmB subjects (20%) and 1 placebo subject (5%); 1 (5%) and 3 (15%) subjects in the respective groups developed colonization while receiving study drug. No L-AmB subjects and 1 placebo subject developed candidiasis. One subject in each group died; these deaths were not considered related to study drug or fungal infection. There were no clinical differences between groups in the incidence of grade III–IV IVH, NEC, hypokalemia, nephrotoxicity, need for platelet or packed red blood cell transfusion, or mortality. Conclusions: L-AmB 5 mg/kg once weekly was generally well tolerated in these VLBW infants. The data did not allow evaluation of efficacy. A larger, multicenter, randomized clinical trial of L-AmB for Candida prophylaxis that is appropriately powered is warranted.</description><subject>Amphotericin B - administration & dosage</subject><subject>Amphotericin B - adverse effects</subject><subject>Antifungal agents</subject><subject>Antifungal Agents - administration & dosage</subject><subject>Antifungal Agents - adverse effects</subject><subject>Biological and medical sciences</subject><subject>Birth weight</subject><subject>Bone marrow</subject><subject>Candida prophylaxis</subject><subject>Candidiasis - diagnosis</subject><subject>Candidiasis - etiology</subject><subject>Candidiasis - prevention & control</subject><subject>Children & youth</subject><subject>Disease prevention</subject><subject>Diseases of mother, fetus and pregnancy</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Fungal infections</subject><subject>Gestational Age</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Humans</subject><subject>Infant, Newborn</subject><subject>Infant, Premature</subject><subject>Infant, Very Low Birth Weight</subject><subject>Infectious diseases</subject><subject>Intensive care</subject><subject>Internal Medicine</subject><subject>liposomal amphotericin B</subject><subject>Male</subject><subject>Medical Education</subject><subject>Medical sciences</subject><subject>Mortality</subject><subject>neonates</subject><subject>Pediatrics</subject><subject>Pharmacokinetics</subject><subject>Pharmacology. Drug treatments</subject><subject>Pilot Projects</subject><subject>Pregnancy. Fetus. Placenta</subject><subject>Premature babies</subject><subject>Premature birth</subject><subject>Prospective Studies</subject><subject>Stem cell transplantation</subject><subject>Treatment Outcome</subject><issn>0149-2918</issn><issn>1879-114X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqNktuO0zAQhiMEYpeFVwBLCHHTFB9yKhdIpeIkrbQXgMSd5dhT6q4TZ22npbwT78hELbvSXnFjS-Pvn_yZf7LsBaNzRln1ZjvXzvZpA0HNOcUq5XOsP8jOWVMvcsaKHw-zc8qKRc4XrDnLnsS4pZSKRckfZ2ecclrVTXGe_bnqNeR7gGt3IM4OPvpOOaK6YeMTBKttT94TFclK9cYaRYbgh83BqV82EnzbQUCd35PWhrQhe7A_Nwkh6FQaAyCyVn2Kb8lyUsYBdLI7mJGA7Xxnf4OZET9AnzvVgpuRwSkNrc-171PwzoEhg3U-kZhGc3iaPVorF-HZ6b7Ivn_88G31Ob-8-vRltbzMddGIlOs1qKYpmxZYo3jNNNNlWdGqgFbXwDWIguErbXlTlZzXpjJG0aIqRbMQZUvFRfb62Bc934wQk-xs1OCc6sGPUdZCMFqJYiJf3iO3fgw9mpOMIlXhyZCqj5TGGcQAazkE26lwQEhOgcqtvA1UToFKyiXWUfn81H9sOzC3un8JIvDqBKiolVvjYLWNdxwv67IWk9HlkQOc285CkFFbwPCNDRiKNN7-h5l393pMnMXPXsMB4t2fy4gC-XXav2n9GG4euq3EX_l52nU</recordid><startdate>20100201</startdate><enddate>20100201</enddate><creator>Arrieta, Antonio C., MD</creator><creator>Shea, Kathy, BA</creator><creator>Dhar, Vijay, MD</creator><creator>Cleary, John P., MD</creator><creator>Kukreja, Sudeep, MD</creator><creator>Morris, Mindy, RNP</creator><creator>Vargas-Shiraishi, Ofelia M., MS</creator><creator>Ashouri, Negar, MD</creator><creator>Singh, Jasjit, MD</creator><general>EM Inc USA</general><general>Elsevier</general><general>Elsevier Limited</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>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20100201</creationdate><title>Once-weekly liposomal amphotericin B as Candida prophylaxis in very low birth weight premature infants: A prospective, randomized, open-label, placebo-controlled pilot study</title><author>Arrieta, Antonio C., MD ; Shea, Kathy, BA ; Dhar, Vijay, MD ; Cleary, John P., MD ; Kukreja, Sudeep, MD ; Morris, Mindy, RNP ; Vargas-Shiraishi, Ofelia M., MS ; Ashouri, Negar, MD ; Singh, Jasjit, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c483t-cfea8858be18a271c1c556064ebc7e2ce34158b0b2865227d6dda046538935b03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Amphotericin B - administration & dosage</topic><topic>Amphotericin B - adverse effects</topic><topic>Antifungal agents</topic><topic>Antifungal Agents - administration & dosage</topic><topic>Antifungal Agents - adverse effects</topic><topic>Biological and medical sciences</topic><topic>Birth weight</topic><topic>Bone marrow</topic><topic>Candida prophylaxis</topic><topic>Candidiasis - diagnosis</topic><topic>Candidiasis - etiology</topic><topic>Candidiasis - prevention & control</topic><topic>Children & youth</topic><topic>Disease prevention</topic><topic>Diseases of mother, fetus and pregnancy</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Fungal infections</topic><topic>Gestational Age</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Humans</topic><topic>Infant, Newborn</topic><topic>Infant, Premature</topic><topic>Infant, Very Low Birth Weight</topic><topic>Infectious diseases</topic><topic>Intensive care</topic><topic>Internal Medicine</topic><topic>liposomal amphotericin B</topic><topic>Male</topic><topic>Medical Education</topic><topic>Medical sciences</topic><topic>Mortality</topic><topic>neonates</topic><topic>Pediatrics</topic><topic>Pharmacokinetics</topic><topic>Pharmacology. Drug treatments</topic><topic>Pilot Projects</topic><topic>Pregnancy. Fetus. Placenta</topic><topic>Premature babies</topic><topic>Premature birth</topic><topic>Prospective Studies</topic><topic>Stem cell transplantation</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Arrieta, Antonio C., MD</creatorcontrib><creatorcontrib>Shea, Kathy, BA</creatorcontrib><creatorcontrib>Dhar, Vijay, MD</creatorcontrib><creatorcontrib>Cleary, John P., MD</creatorcontrib><creatorcontrib>Kukreja, Sudeep, MD</creatorcontrib><creatorcontrib>Morris, Mindy, RNP</creatorcontrib><creatorcontrib>Vargas-Shiraishi, Ofelia M., MS</creatorcontrib><creatorcontrib>Ashouri, Negar, MD</creatorcontrib><creatorcontrib>Singh, Jasjit, MD</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>Proquest Nursing & Allied Health Source</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</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>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Research Library (Corporate)</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>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Arrieta, Antonio C., MD</au><au>Shea, Kathy, BA</au><au>Dhar, Vijay, MD</au><au>Cleary, John P., MD</au><au>Kukreja, Sudeep, MD</au><au>Morris, Mindy, RNP</au><au>Vargas-Shiraishi, Ofelia M., MS</au><au>Ashouri, Negar, MD</au><au>Singh, Jasjit, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Once-weekly liposomal amphotericin B as Candida prophylaxis in very low birth weight premature infants: A prospective, randomized, open-label, placebo-controlled pilot study</atitle><jtitle>Clinical therapeutics</jtitle><addtitle>Clin Ther</addtitle><date>2010-02-01</date><risdate>2010</risdate><volume>32</volume><issue>2</issue><spage>265</spage><epage>271</epage><pages>265-271</pages><issn>0149-2918</issn><eissn>1879-114X</eissn><abstract>Abstract Objective: This study was conducted to evaluate once-weekly liposomal amphotericin B (L-AmB) for Candida prophylaxis in very low birth weight (VLBW) neonates. Methods: This prospective, randomized, open-label, placebo-controlled study included neonates who were <32 weeks’ gestational age, <7 days old, and weighing <1500 g at birth. Subjects were randomized to receive L-AmB 5 mg/kg per week or placebo (dextrose water) and were followed until 6 weeks of age. Surveillance cultures were obtained at baseline, at 72 hours, and weekly thereafter. Study drug was continued until 6 weeks after birth or the discontinuation of high-risk treatments and invasive devices, whichever occurred first. Blood cultures were obtained as clinically indicated. The primary end point was development of Candida colonization by 6 weeks’ postnatal age; secondary end points included development of invasive candidiasis and occurrence of treatment-related adverse events. Safety variables included renal and hepatic function tests, incidence of grade III–IV intraventricular hemorrhage (IVH) and necrotizing enterocolitis (NEC), and mortality. Results: Forty subjects were enrolled and randomized to receive L-AmB (12 males, 8 females; 50% white) or placebo (12 males, 8 females; 35% white). Subjects were evenly distributed by gestational age, age at enrollment, birth weight, race, and sex. Consent was withdrawn after completion of study treatment in 1 subject (L-AmB); 1 subject in each study arm died during the study; and 3 subjects were transferred back to their referring institutions (1 L-AmB, 2 placebo). Thus, 17 subjects in each arm completed all study procedures, although all 40 subjects were evaluable. Colonization before administration of study drug was noted in 4 L-AmB subjects (20%) and 1 placebo subject (5%); 1 (5%) and 3 (15%) subjects in the respective groups developed colonization while receiving study drug. No L-AmB subjects and 1 placebo subject developed candidiasis. One subject in each group died; these deaths were not considered related to study drug or fungal infection. There were no clinical differences between groups in the incidence of grade III–IV IVH, NEC, hypokalemia, nephrotoxicity, need for platelet or packed red blood cell transfusion, or mortality. Conclusions: L-AmB 5 mg/kg once weekly was generally well tolerated in these VLBW infants. The data did not allow evaluation of efficacy. A larger, multicenter, randomized clinical trial of L-AmB for Candida prophylaxis that is appropriately powered is warranted.</abstract><cop>Bridgewater, NJ</cop><pub>EM Inc USA</pub><pmid>20206784</pmid><doi>10.1016/j.clinthera.2010.02.016</doi><tpages>7</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0149-2918 |
| ispartof | Clinical therapeutics, 2010-02, Vol.32 (2), p.265-271 |
| issn | 0149-2918 1879-114X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_733106340 |
| source | MEDLINE; ScienceDirect Journals (5 years ago - present); ProQuest Central UK/Ireland |
| subjects | Amphotericin B - administration & dosage Amphotericin B - adverse effects Antifungal agents Antifungal Agents - administration & dosage Antifungal Agents - adverse effects Biological and medical sciences Birth weight Bone marrow Candida prophylaxis Candidiasis - diagnosis Candidiasis - etiology Candidiasis - prevention & control Children & youth Disease prevention Diseases of mother, fetus and pregnancy Drug Administration Schedule Female Fungal infections Gestational Age Gynecology. Andrology. Obstetrics Humans Infant, Newborn Infant, Premature Infant, Very Low Birth Weight Infectious diseases Intensive care Internal Medicine liposomal amphotericin B Male Medical Education Medical sciences Mortality neonates Pediatrics Pharmacokinetics Pharmacology. Drug treatments Pilot Projects Pregnancy. Fetus. Placenta Premature babies Premature birth Prospective Studies Stem cell transplantation Treatment Outcome |
| title | Once-weekly liposomal amphotericin B as Candida prophylaxis in very low birth weight premature infants: A prospective, randomized, open-label, placebo-controlled pilot study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-06T21%3A49%3A44IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Once-weekly%20liposomal%20amphotericin%20B%20as%20Candida%20prophylaxis%20in%20very%20low%20birth%20weight%20premature%20infants:%20A%20prospective,%20randomized,%20open-label,%20placebo-controlled%20pilot%20study&rft.jtitle=Clinical%20therapeutics&rft.au=Arrieta,%20Antonio%20C.,%20MD&rft.date=2010-02-01&rft.volume=32&rft.issue=2&rft.spage=265&rft.epage=271&rft.pages=265-271&rft.issn=0149-2918&rft.eissn=1879-114X&rft_id=info:doi/10.1016/j.clinthera.2010.02.016&rft_dat=%3Cproquest_cross%3E2734245441%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1033161031&rft_id=info:pmid/20206784&rft_els_id=1_s2_0_S0149291810000676&rfr_iscdi=true |