Micafungin Versus Liposomal Amphotericin B for Pediatric Patients With Invasive Candidiasis: Substudy of a Randomized Double-Blind Trial
BACKGROUND:Invasive candidiasis is increasingly prevalent in premature infants and seriously ill children, and pediatric data on available antifungal therapies are lacking. METHODS:We conducted a pediatric substudy as part of a double-blind, randomized, multinational trial to compare micafungin (2 m...
Gespeichert in:
| Veröffentlicht in: | The Pediatric infectious disease journal 2008-09, Vol.27 (9), p.820-826 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 826 |
|---|---|
| container_issue | 9 |
| container_start_page | 820 |
| container_title | The Pediatric infectious disease journal |
| container_volume | 27 |
| creator | Queiroz-Telles, Flavio Berezin, Eitan Leverger, Guy Freire, Antonio van der Vyver, Annalie Chotpitayasunondh, Tawee Konja, Josip Diekmann-Berndt, Heike Koblinger, Sonja Groll, Andreas H Arrieta, Antonio |
| description | BACKGROUND:Invasive candidiasis is increasingly prevalent in premature infants and seriously ill children, and pediatric data on available antifungal therapies are lacking.
METHODS:We conducted a pediatric substudy as part of a double-blind, randomized, multinational trial to compare micafungin (2 mg/kg) with liposomal amphotericin B (3 mg/kg) as first-line treatment of invasive candidiasis. Treatment success was defined as clinical and mycologic response at the end of therapy. Statistical analyses were descriptive, as the sample size meant that the study was not powered for hypothesis testing.
RESULTS:One hundred six patients were included in the intent-to-treat population; and 98 patients—48 patients in the micafungin group and 50 patients in the liposomal amphotericin B group—in the modified intent-to-treat population. Baseline characteristics were balanced between treatment groups. Overall, 57 patients were |
| doi_str_mv | 10.1097/INF.0b013e31817275e6 |
| format | Article |
| fullrecord | <record><control><sourceid>pubmed_cross</sourceid><recordid>TN_cdi_crossref_primary_10_1097_INF_0b013e31817275e6</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>18679151</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3290-82b5e76a4c36d353021994e4e6dbb9f9db540be406a0d9faf18aea4b2694588c3</originalsourceid><addsrcrecordid>eNpdkc9uFDEMxiMEokvhDRDKheMUZ5LJJNzaLYWVFqigwHHkTDxsYP6skplW5Ql4bIK6ohIHy7L9fbb0M2PPBZwIsPWrzYeLE3AgJElhRF3WFekHbCUqWRZgTf2QrcBYUUitzRF7ktIPAJBKwGN2JIyurajEiv1-H1rslvF7GPlXimlJfBv2U5oG7PnpsN9NM8XQ5ukZ76bIL8kHnHOHX-IcaJwT_xbmHd-M15jCNfE1jj5kTQrpNf-8uDQv_pZPHUf-KY-mIfwiz8-nxfVUnPVh9PwqBuyfskcd9omeHfIx-3Lx5mr9rth-fLtZn26LVpYWClO6imqNqpXay0pCKaxVpEh752xnvasUOFKgEbztsBMGCZUrtVWVMa08ZupubxunlCJ1zT6GAeNtI6D5C7bJYJv_wWbbizvbfnED-XvTgWQWvDwIMLXYdxHHNqR_uhK0qG1p7-_fTH1Gm372yw3FZkfYz7smvwi0qlRRAhiwuSpyCJB_AGcZkzA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Micafungin Versus Liposomal Amphotericin B for Pediatric Patients With Invasive Candidiasis: Substudy of a Randomized Double-Blind Trial</title><source>MEDLINE</source><source>Journals@Ovid Complete</source><creator>Queiroz-Telles, Flavio ; Berezin, Eitan ; Leverger, Guy ; Freire, Antonio ; van der Vyver, Annalie ; Chotpitayasunondh, Tawee ; Konja, Josip ; Diekmann-Berndt, Heike ; Koblinger, Sonja ; Groll, Andreas H ; Arrieta, Antonio</creator><creatorcontrib>Queiroz-Telles, Flavio ; Berezin, Eitan ; Leverger, Guy ; Freire, Antonio ; van der Vyver, Annalie ; Chotpitayasunondh, Tawee ; Konja, Josip ; Diekmann-Berndt, Heike ; Koblinger, Sonja ; Groll, Andreas H ; Arrieta, Antonio ; Micafungin Invasive Candidiasis Study Group</creatorcontrib><description>BACKGROUND:Invasive candidiasis is increasingly prevalent in premature infants and seriously ill children, and pediatric data on available antifungal therapies are lacking.
METHODS:We conducted a pediatric substudy as part of a double-blind, randomized, multinational trial to compare micafungin (2 mg/kg) with liposomal amphotericin B (3 mg/kg) as first-line treatment of invasive candidiasis. Treatment success was defined as clinical and mycologic response at the end of therapy. Statistical analyses were descriptive, as the sample size meant that the study was not powered for hypothesis testing.
RESULTS:One hundred six patients were included in the intent-to-treat population; and 98 patients—48 patients in the micafungin group and 50 patients in the liposomal amphotericin B group—in the modified intent-to-treat population. Baseline characteristics were balanced between treatment groups. Overall, 57 patients were <2 years old including 19 patients who were premature at birth; and 41 patients were 2 to <16 years old. Most patients (91/98, 92.9%) had candidemia, and 7/98 (7.1%) patients had other forms of invasive candidiasis. Treatment success was observed for 35/48 (72.9%) patients treated with micafungin and 38/50 (76.0%) patients treated with liposomal amphotericin B. The difference in proportions adjusted for neutropenic status was −2.4% [95% CI(−20.1 to 15.3)]. Efficacy findings were consistent, independent of the neutropenic status, the age of the patient, and whether the patient was premature at birth. Both treatments were well tolerated, but with a lower incidence of adverse events that led to discontinuation in the micafungin group (2/52, 3.8%) compared with the liposomal amphotericin B group (9/54, 16.7%) (P = 0.05, Fisher exact test).
CONCLUSIONS:Micafungin seems to be similarly effective and as safe as liposomal amphotericin B for the treatment of invasive candidiasis in pediatric patients. (ClinicalTrials.gov number, NCT00106288).</description><identifier>ISSN: 0891-3668</identifier><identifier>EISSN: 1532-0987</identifier><identifier>DOI: 10.1097/INF.0b013e31817275e6</identifier><identifier>PMID: 18679151</identifier><identifier>CODEN: PIDJEV</identifier><language>eng</language><publisher>Baltimore, MD: Lippincott Williams & Wilkins, Inc</publisher><subject>Adolescent ; Amphotericin B - administration & dosage ; Amphotericin B - adverse effects ; Amphotericin B - therapeutic use ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antifungal agents ; Antifungal Agents - administration & dosage ; Antifungal Agents - therapeutic use ; Antiparasitic agents ; Biological and medical sciences ; Candidiasis - drug therapy ; Child ; Child, Preschool ; Double-Blind Method ; Echinocandins - administration & dosage ; Echinocandins - adverse effects ; Echinocandins - therapeutic use ; Humans ; Infant ; Infant, Newborn ; Infant, Premature ; Infectious diseases ; Lipopeptides ; Lipoproteins - administration & dosage ; Lipoproteins - adverse effects ; Lipoproteins - therapeutic use ; Medical sciences ; Pharmacology. Drug treatments ; Treatment Outcome</subject><ispartof>The Pediatric infectious disease journal, 2008-09, Vol.27 (9), p.820-826</ispartof><rights>2008 Lippincott Williams & Wilkins, Inc.</rights><rights>2008 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3290-82b5e76a4c36d353021994e4e6dbb9f9db540be406a0d9faf18aea4b2694588c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20617929$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18679151$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Queiroz-Telles, Flavio</creatorcontrib><creatorcontrib>Berezin, Eitan</creatorcontrib><creatorcontrib>Leverger, Guy</creatorcontrib><creatorcontrib>Freire, Antonio</creatorcontrib><creatorcontrib>van der Vyver, Annalie</creatorcontrib><creatorcontrib>Chotpitayasunondh, Tawee</creatorcontrib><creatorcontrib>Konja, Josip</creatorcontrib><creatorcontrib>Diekmann-Berndt, Heike</creatorcontrib><creatorcontrib>Koblinger, Sonja</creatorcontrib><creatorcontrib>Groll, Andreas H</creatorcontrib><creatorcontrib>Arrieta, Antonio</creatorcontrib><creatorcontrib>Micafungin Invasive Candidiasis Study Group</creatorcontrib><title>Micafungin Versus Liposomal Amphotericin B for Pediatric Patients With Invasive Candidiasis: Substudy of a Randomized Double-Blind Trial</title><title>The Pediatric infectious disease journal</title><addtitle>Pediatr Infect Dis J</addtitle><description>BACKGROUND:Invasive candidiasis is increasingly prevalent in premature infants and seriously ill children, and pediatric data on available antifungal therapies are lacking.
METHODS:We conducted a pediatric substudy as part of a double-blind, randomized, multinational trial to compare micafungin (2 mg/kg) with liposomal amphotericin B (3 mg/kg) as first-line treatment of invasive candidiasis. Treatment success was defined as clinical and mycologic response at the end of therapy. Statistical analyses were descriptive, as the sample size meant that the study was not powered for hypothesis testing.
RESULTS:One hundred six patients were included in the intent-to-treat population; and 98 patients—48 patients in the micafungin group and 50 patients in the liposomal amphotericin B group—in the modified intent-to-treat population. Baseline characteristics were balanced between treatment groups. Overall, 57 patients were <2 years old including 19 patients who were premature at birth; and 41 patients were 2 to <16 years old. Most patients (91/98, 92.9%) had candidemia, and 7/98 (7.1%) patients had other forms of invasive candidiasis. Treatment success was observed for 35/48 (72.9%) patients treated with micafungin and 38/50 (76.0%) patients treated with liposomal amphotericin B. The difference in proportions adjusted for neutropenic status was −2.4% [95% CI(−20.1 to 15.3)]. Efficacy findings were consistent, independent of the neutropenic status, the age of the patient, and whether the patient was premature at birth. Both treatments were well tolerated, but with a lower incidence of adverse events that led to discontinuation in the micafungin group (2/52, 3.8%) compared with the liposomal amphotericin B group (9/54, 16.7%) (P = 0.05, Fisher exact test).
CONCLUSIONS:Micafungin seems to be similarly effective and as safe as liposomal amphotericin B for the treatment of invasive candidiasis in pediatric patients. (ClinicalTrials.gov number, NCT00106288).</description><subject>Adolescent</subject><subject>Amphotericin B - administration & dosage</subject><subject>Amphotericin B - adverse effects</subject><subject>Amphotericin B - therapeutic use</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antifungal agents</subject><subject>Antifungal Agents - administration & dosage</subject><subject>Antifungal Agents - therapeutic use</subject><subject>Antiparasitic agents</subject><subject>Biological and medical sciences</subject><subject>Candidiasis - drug therapy</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Double-Blind Method</subject><subject>Echinocandins - administration & dosage</subject><subject>Echinocandins - adverse effects</subject><subject>Echinocandins - therapeutic use</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Infant, Premature</subject><subject>Infectious diseases</subject><subject>Lipopeptides</subject><subject>Lipoproteins - administration & dosage</subject><subject>Lipoproteins - adverse effects</subject><subject>Lipoproteins - therapeutic use</subject><subject>Medical sciences</subject><subject>Pharmacology. Drug treatments</subject><subject>Treatment Outcome</subject><issn>0891-3668</issn><issn>1532-0987</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkc9uFDEMxiMEokvhDRDKheMUZ5LJJNzaLYWVFqigwHHkTDxsYP6skplW5Ql4bIK6ohIHy7L9fbb0M2PPBZwIsPWrzYeLE3AgJElhRF3WFekHbCUqWRZgTf2QrcBYUUitzRF7ktIPAJBKwGN2JIyurajEiv1-H1rslvF7GPlXimlJfBv2U5oG7PnpsN9NM8XQ5ukZ76bIL8kHnHOHX-IcaJwT_xbmHd-M15jCNfE1jj5kTQrpNf-8uDQv_pZPHUf-KY-mIfwiz8-nxfVUnPVh9PwqBuyfskcd9omeHfIx-3Lx5mr9rth-fLtZn26LVpYWClO6imqNqpXay0pCKaxVpEh752xnvasUOFKgEbztsBMGCZUrtVWVMa08ZupubxunlCJ1zT6GAeNtI6D5C7bJYJv_wWbbizvbfnED-XvTgWQWvDwIMLXYdxHHNqR_uhK0qG1p7-_fTH1Gm372yw3FZkfYz7smvwi0qlRRAhiwuSpyCJB_AGcZkzA</recordid><startdate>200809</startdate><enddate>200809</enddate><creator>Queiroz-Telles, Flavio</creator><creator>Berezin, Eitan</creator><creator>Leverger, Guy</creator><creator>Freire, Antonio</creator><creator>van der Vyver, Annalie</creator><creator>Chotpitayasunondh, Tawee</creator><creator>Konja, Josip</creator><creator>Diekmann-Berndt, Heike</creator><creator>Koblinger, Sonja</creator><creator>Groll, Andreas H</creator><creator>Arrieta, Antonio</creator><general>Lippincott Williams & Wilkins, Inc</general><general>Lippincott</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></search><sort><creationdate>200809</creationdate><title>Micafungin Versus Liposomal Amphotericin B for Pediatric Patients With Invasive Candidiasis: Substudy of a Randomized Double-Blind Trial</title><author>Queiroz-Telles, Flavio ; Berezin, Eitan ; Leverger, Guy ; Freire, Antonio ; van der Vyver, Annalie ; Chotpitayasunondh, Tawee ; Konja, Josip ; Diekmann-Berndt, Heike ; Koblinger, Sonja ; Groll, Andreas H ; Arrieta, Antonio</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3290-82b5e76a4c36d353021994e4e6dbb9f9db540be406a0d9faf18aea4b2694588c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adolescent</topic><topic>Amphotericin B - administration & dosage</topic><topic>Amphotericin B - adverse effects</topic><topic>Amphotericin B - therapeutic use</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antifungal agents</topic><topic>Antifungal Agents - administration & dosage</topic><topic>Antifungal Agents - therapeutic use</topic><topic>Antiparasitic agents</topic><topic>Biological and medical sciences</topic><topic>Candidiasis - drug therapy</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Double-Blind Method</topic><topic>Echinocandins - administration & dosage</topic><topic>Echinocandins - adverse effects</topic><topic>Echinocandins - therapeutic use</topic><topic>Humans</topic><topic>Infant</topic><topic>Infant, Newborn</topic><topic>Infant, Premature</topic><topic>Infectious diseases</topic><topic>Lipopeptides</topic><topic>Lipoproteins - administration & dosage</topic><topic>Lipoproteins - adverse effects</topic><topic>Lipoproteins - therapeutic use</topic><topic>Medical sciences</topic><topic>Pharmacology. Drug treatments</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Queiroz-Telles, Flavio</creatorcontrib><creatorcontrib>Berezin, Eitan</creatorcontrib><creatorcontrib>Leverger, Guy</creatorcontrib><creatorcontrib>Freire, Antonio</creatorcontrib><creatorcontrib>van der Vyver, Annalie</creatorcontrib><creatorcontrib>Chotpitayasunondh, Tawee</creatorcontrib><creatorcontrib>Konja, Josip</creatorcontrib><creatorcontrib>Diekmann-Berndt, Heike</creatorcontrib><creatorcontrib>Koblinger, Sonja</creatorcontrib><creatorcontrib>Groll, Andreas H</creatorcontrib><creatorcontrib>Arrieta, Antonio</creatorcontrib><creatorcontrib>Micafungin Invasive Candidiasis Study Group</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><jtitle>The Pediatric infectious disease journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Queiroz-Telles, Flavio</au><au>Berezin, Eitan</au><au>Leverger, Guy</au><au>Freire, Antonio</au><au>van der Vyver, Annalie</au><au>Chotpitayasunondh, Tawee</au><au>Konja, Josip</au><au>Diekmann-Berndt, Heike</au><au>Koblinger, Sonja</au><au>Groll, Andreas H</au><au>Arrieta, Antonio</au><aucorp>Micafungin Invasive Candidiasis Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Micafungin Versus Liposomal Amphotericin B for Pediatric Patients With Invasive Candidiasis: Substudy of a Randomized Double-Blind Trial</atitle><jtitle>The Pediatric infectious disease journal</jtitle><addtitle>Pediatr Infect Dis J</addtitle><date>2008-09</date><risdate>2008</risdate><volume>27</volume><issue>9</issue><spage>820</spage><epage>826</epage><pages>820-826</pages><issn>0891-3668</issn><eissn>1532-0987</eissn><coden>PIDJEV</coden><abstract>BACKGROUND:Invasive candidiasis is increasingly prevalent in premature infants and seriously ill children, and pediatric data on available antifungal therapies are lacking.
METHODS:We conducted a pediatric substudy as part of a double-blind, randomized, multinational trial to compare micafungin (2 mg/kg) with liposomal amphotericin B (3 mg/kg) as first-line treatment of invasive candidiasis. Treatment success was defined as clinical and mycologic response at the end of therapy. Statistical analyses were descriptive, as the sample size meant that the study was not powered for hypothesis testing.
RESULTS:One hundred six patients were included in the intent-to-treat population; and 98 patients—48 patients in the micafungin group and 50 patients in the liposomal amphotericin B group—in the modified intent-to-treat population. Baseline characteristics were balanced between treatment groups. Overall, 57 patients were <2 years old including 19 patients who were premature at birth; and 41 patients were 2 to <16 years old. Most patients (91/98, 92.9%) had candidemia, and 7/98 (7.1%) patients had other forms of invasive candidiasis. Treatment success was observed for 35/48 (72.9%) patients treated with micafungin and 38/50 (76.0%) patients treated with liposomal amphotericin B. The difference in proportions adjusted for neutropenic status was −2.4% [95% CI(−20.1 to 15.3)]. Efficacy findings were consistent, independent of the neutropenic status, the age of the patient, and whether the patient was premature at birth. Both treatments were well tolerated, but with a lower incidence of adverse events that led to discontinuation in the micafungin group (2/52, 3.8%) compared with the liposomal amphotericin B group (9/54, 16.7%) (P = 0.05, Fisher exact test).
CONCLUSIONS:Micafungin seems to be similarly effective and as safe as liposomal amphotericin B for the treatment of invasive candidiasis in pediatric patients. (ClinicalTrials.gov number, NCT00106288).</abstract><cop>Baltimore, MD</cop><cop>Philadelphia, PA</cop><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins, Inc</pub><pmid>18679151</pmid><doi>10.1097/INF.0b013e31817275e6</doi><tpages>7</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0891-3668 |
| ispartof | The Pediatric infectious disease journal, 2008-09, Vol.27 (9), p.820-826 |
| issn | 0891-3668 1532-0987 |
| language | eng |
| recordid | cdi_crossref_primary_10_1097_INF_0b013e31817275e6 |
| source | MEDLINE; Journals@Ovid Complete |
| subjects | Adolescent Amphotericin B - administration & dosage Amphotericin B - adverse effects Amphotericin B - therapeutic use Antibiotics. Antiinfectious agents. Antiparasitic agents Antifungal agents Antifungal Agents - administration & dosage Antifungal Agents - therapeutic use Antiparasitic agents Biological and medical sciences Candidiasis - drug therapy Child Child, Preschool Double-Blind Method Echinocandins - administration & dosage Echinocandins - adverse effects Echinocandins - therapeutic use Humans Infant Infant, Newborn Infant, Premature Infectious diseases Lipopeptides Lipoproteins - administration & dosage Lipoproteins - adverse effects Lipoproteins - therapeutic use Medical sciences Pharmacology. Drug treatments Treatment Outcome |
| title | Micafungin Versus Liposomal Amphotericin B for Pediatric Patients With Invasive Candidiasis: Substudy of a Randomized Double-Blind Trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-08T11%3A16%3A48IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-pubmed_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Micafungin%20Versus%20Liposomal%20Amphotericin%20B%20for%20Pediatric%20Patients%20With%20Invasive%20Candidiasis:%20Substudy%20of%20a%20Randomized%20Double-Blind%20Trial&rft.jtitle=The%20Pediatric%20infectious%20disease%20journal&rft.au=Queiroz-Telles,%20Flavio&rft.aucorp=Micafungin%20Invasive%20Candidiasis%20Study%20Group&rft.date=2008-09&rft.volume=27&rft.issue=9&rft.spage=820&rft.epage=826&rft.pages=820-826&rft.issn=0891-3668&rft.eissn=1532-0987&rft.coden=PIDJEV&rft_id=info:doi/10.1097/INF.0b013e31817275e6&rft_dat=%3Cpubmed_cross%3E18679151%3C/pubmed_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_id=info:pmid/18679151&rfr_iscdi=true |