Oral Valganciclovir Initiated Beyond 1 Month of Age as Treatment of Sensorineural Hearing Loss Caused by Congenital Cytomegalovirus Infection: A Randomized Clinical Trial
The objective of this study was to determine if valganciclovir initiated after 1 month of age improves congenital cytomegalovirus–associated sensorineural hearing loss. We conducted a randomized, double-blind, placebo-controlled phase 2 trial of 6 weeks of oral valganciclovir at US (n = 12) and UK (...
Gespeichert in:
| Veröffentlicht in: | The Journal of pediatrics 2024-05, Vol.268, p.113934-113934, Article 113934 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 113934 |
|---|---|
| container_issue | |
| container_start_page | 113934 |
| container_title | The Journal of pediatrics |
| container_volume | 268 |
| creator | Kimberlin, David W. Aban, Inmaculada Peri, Kalyani Nishikawa, Javier K. Bernatoniene, Jolanta Emonts, Marieke Klein, Nigel Bamford, Alasdair DeBiasi, Roberta L. Faust, Saul N. Jones, Christine E. McMaster, Paddy Caserta, Mary Ahmed, Amina Sharland, Mike Demmler-Harrison, Gail Hackett, Scott Sánchez, Pablo J. Shackley, Fiona Kelly, Dominic Dennehy, Penelope H. Storch, Gregory A. Whitley, Richard J. Griffiths, Paul |
| description | The objective of this study was to determine if valganciclovir initiated after 1 month of age improves congenital cytomegalovirus–associated sensorineural hearing loss.
We conducted a randomized, double-blind, placebo-controlled phase 2 trial of 6 weeks of oral valganciclovir at US (n = 12) and UK (n = 9) sites. Patients of ages 1 month through 3 years with baseline sensorineural hearing loss were enrolled. The primary outcome was change in total ear hearing between baseline and study month 6. Secondary outcome measures included change in best ear hearing and reduction in cytomegalovirus viral load in blood, saliva, and urine.
Of 54 participants enrolled, 35 were documented to have congenital cytomegalovirus infection and were randomized (active group: 17; placebo group: 18). Mean age at enrollment was 17.8 ± 15.8 months (valganciclovir) vs 19.5 ± 13.1 months (placebo). Twenty (76.9%) of the 26 ears from subjects in the active treatment group did not have worsening of hearing, compared with 27 (96.4%) of 28 ears from subjects in the placebo group (P = .09). All other comparisons of total ear or best ear hearing outcomes were also not statistically significant. Saliva and urine viral loads decreased significantly in the valganciclovir group but did not correlate with change in hearing outcome.
In this randomized controlled trial, initiation of antiviral therapy beyond the first month of age did not improve hearing outcomes in children with congenital cytomegalovirus–associated sensorineural hearing loss.
ClinicalTrials.gov identifier NCT01649869. |
| doi_str_mv | 10.1016/j.jpeds.2024.113934 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2929131447</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0022347624000374</els_id><sourcerecordid>2929131447</sourcerecordid><originalsourceid>FETCH-LOGICAL-c381t-bea35a4e7deb11b0776a747b084daa9317b29a2e653df25ec676139e6019b2ce3</originalsourceid><addsrcrecordid>eNp9kc-O0zAQxi0EEmXhCbj4yCXF_xo3SBxKBOxKRStB4WpNnElwldjFdlYqj8RT4m45c5rR6Pt9o5mPkNecrTnj9dvj-njCPq0FE2rNuWykekJWnDW6qrdSPiUrxoSopNL1c_IipSNjrFGMrcif-wgT_QHTCN46O4UHF-mdd9lBxp5-wHPwPeX0S_D5Jw0D3Y1IIdFDRMgz-nyZfUOfQnQel4vZLULpR7oPKdEWllR8ujNtgx-xGBdFe85hxhEety2p7BvQZhf8O7qjX8H3YXa_C9VOzjtbgEN0ML0kzwaYEr76V2_I908fD-1ttb__fNfu9pWVW56rDkFuQKHuseO8Y1rXoJXu2Fb1AI3kuhMNCKw3sh_EBm2t6_IxrBlvOmFR3pA3V99TDL8WTNnMLlmcJvAYlmREIxouuVK6SOVVamM5NuJgTtHNEM-GM3NJxhzNYzLmkoy5JlOo91cKyxUPDqNJ1qG32LtY_mD64P7L_wWPSpqv</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2929131447</pqid></control><display><type>article</type><title>Oral Valganciclovir Initiated Beyond 1 Month of Age as Treatment of Sensorineural Hearing Loss Caused by Congenital Cytomegalovirus Infection: A Randomized Clinical Trial</title><source>ScienceDirect Journals (5 years ago - present)</source><creator>Kimberlin, David W. ; Aban, Inmaculada ; Peri, Kalyani ; Nishikawa, Javier K. ; Bernatoniene, Jolanta ; Emonts, Marieke ; Klein, Nigel ; Bamford, Alasdair ; DeBiasi, Roberta L. ; Faust, Saul N. ; Jones, Christine E. ; McMaster, Paddy ; Caserta, Mary ; Ahmed, Amina ; Sharland, Mike ; Demmler-Harrison, Gail ; Hackett, Scott ; Sánchez, Pablo J. ; Shackley, Fiona ; Kelly, Dominic ; Dennehy, Penelope H. ; Storch, Gregory A. ; Whitley, Richard J. ; Griffiths, Paul</creator><creatorcontrib>Kimberlin, David W. ; Aban, Inmaculada ; Peri, Kalyani ; Nishikawa, Javier K. ; Bernatoniene, Jolanta ; Emonts, Marieke ; Klein, Nigel ; Bamford, Alasdair ; DeBiasi, Roberta L. ; Faust, Saul N. ; Jones, Christine E. ; McMaster, Paddy ; Caserta, Mary ; Ahmed, Amina ; Sharland, Mike ; Demmler-Harrison, Gail ; Hackett, Scott ; Sánchez, Pablo J. ; Shackley, Fiona ; Kelly, Dominic ; Dennehy, Penelope H. ; Storch, Gregory A. ; Whitley, Richard J. ; Griffiths, Paul ; Collaborative Antiviral Study Group (CASG)</creatorcontrib><description>The objective of this study was to determine if valganciclovir initiated after 1 month of age improves congenital cytomegalovirus–associated sensorineural hearing loss.
We conducted a randomized, double-blind, placebo-controlled phase 2 trial of 6 weeks of oral valganciclovir at US (n = 12) and UK (n = 9) sites. Patients of ages 1 month through 3 years with baseline sensorineural hearing loss were enrolled. The primary outcome was change in total ear hearing between baseline and study month 6. Secondary outcome measures included change in best ear hearing and reduction in cytomegalovirus viral load in blood, saliva, and urine.
Of 54 participants enrolled, 35 were documented to have congenital cytomegalovirus infection and were randomized (active group: 17; placebo group: 18). Mean age at enrollment was 17.8 ± 15.8 months (valganciclovir) vs 19.5 ± 13.1 months (placebo). Twenty (76.9%) of the 26 ears from subjects in the active treatment group did not have worsening of hearing, compared with 27 (96.4%) of 28 ears from subjects in the placebo group (P = .09). All other comparisons of total ear or best ear hearing outcomes were also not statistically significant. Saliva and urine viral loads decreased significantly in the valganciclovir group but did not correlate with change in hearing outcome.
In this randomized controlled trial, initiation of antiviral therapy beyond the first month of age did not improve hearing outcomes in children with congenital cytomegalovirus–associated sensorineural hearing loss.
ClinicalTrials.gov identifier NCT01649869.</description><identifier>ISSN: 0022-3476</identifier><identifier>EISSN: 1097-6833</identifier><identifier>DOI: 10.1016/j.jpeds.2024.113934</identifier><language>eng</language><publisher>Elsevier Inc</publisher><subject>antiviral therapy ; congenital infection ; cytomegalovirus ; hearing loss</subject><ispartof>The Journal of pediatrics, 2024-05, Vol.268, p.113934-113934, Article 113934</ispartof><rights>2024 Elsevier Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c381t-bea35a4e7deb11b0776a747b084daa9317b29a2e653df25ec676139e6019b2ce3</citedby><cites>FETCH-LOGICAL-c381t-bea35a4e7deb11b0776a747b084daa9317b29a2e653df25ec676139e6019b2ce3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jpeds.2024.113934$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3548,27923,27924,45994</link.rule.ids></links><search><creatorcontrib>Kimberlin, David W.</creatorcontrib><creatorcontrib>Aban, Inmaculada</creatorcontrib><creatorcontrib>Peri, Kalyani</creatorcontrib><creatorcontrib>Nishikawa, Javier K.</creatorcontrib><creatorcontrib>Bernatoniene, Jolanta</creatorcontrib><creatorcontrib>Emonts, Marieke</creatorcontrib><creatorcontrib>Klein, Nigel</creatorcontrib><creatorcontrib>Bamford, Alasdair</creatorcontrib><creatorcontrib>DeBiasi, Roberta L.</creatorcontrib><creatorcontrib>Faust, Saul N.</creatorcontrib><creatorcontrib>Jones, Christine E.</creatorcontrib><creatorcontrib>McMaster, Paddy</creatorcontrib><creatorcontrib>Caserta, Mary</creatorcontrib><creatorcontrib>Ahmed, Amina</creatorcontrib><creatorcontrib>Sharland, Mike</creatorcontrib><creatorcontrib>Demmler-Harrison, Gail</creatorcontrib><creatorcontrib>Hackett, Scott</creatorcontrib><creatorcontrib>Sánchez, Pablo J.</creatorcontrib><creatorcontrib>Shackley, Fiona</creatorcontrib><creatorcontrib>Kelly, Dominic</creatorcontrib><creatorcontrib>Dennehy, Penelope H.</creatorcontrib><creatorcontrib>Storch, Gregory A.</creatorcontrib><creatorcontrib>Whitley, Richard J.</creatorcontrib><creatorcontrib>Griffiths, Paul</creatorcontrib><creatorcontrib>Collaborative Antiviral Study Group (CASG)</creatorcontrib><title>Oral Valganciclovir Initiated Beyond 1 Month of Age as Treatment of Sensorineural Hearing Loss Caused by Congenital Cytomegalovirus Infection: A Randomized Clinical Trial</title><title>The Journal of pediatrics</title><description>The objective of this study was to determine if valganciclovir initiated after 1 month of age improves congenital cytomegalovirus–associated sensorineural hearing loss.
We conducted a randomized, double-blind, placebo-controlled phase 2 trial of 6 weeks of oral valganciclovir at US (n = 12) and UK (n = 9) sites. Patients of ages 1 month through 3 years with baseline sensorineural hearing loss were enrolled. The primary outcome was change in total ear hearing between baseline and study month 6. Secondary outcome measures included change in best ear hearing and reduction in cytomegalovirus viral load in blood, saliva, and urine.
Of 54 participants enrolled, 35 were documented to have congenital cytomegalovirus infection and were randomized (active group: 17; placebo group: 18). Mean age at enrollment was 17.8 ± 15.8 months (valganciclovir) vs 19.5 ± 13.1 months (placebo). Twenty (76.9%) of the 26 ears from subjects in the active treatment group did not have worsening of hearing, compared with 27 (96.4%) of 28 ears from subjects in the placebo group (P = .09). All other comparisons of total ear or best ear hearing outcomes were also not statistically significant. Saliva and urine viral loads decreased significantly in the valganciclovir group but did not correlate with change in hearing outcome.
In this randomized controlled trial, initiation of antiviral therapy beyond the first month of age did not improve hearing outcomes in children with congenital cytomegalovirus–associated sensorineural hearing loss.
ClinicalTrials.gov identifier NCT01649869.</description><subject>antiviral therapy</subject><subject>congenital infection</subject><subject>cytomegalovirus</subject><subject>hearing loss</subject><issn>0022-3476</issn><issn>1097-6833</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNp9kc-O0zAQxi0EEmXhCbj4yCXF_xo3SBxKBOxKRStB4WpNnElwldjFdlYqj8RT4m45c5rR6Pt9o5mPkNecrTnj9dvj-njCPq0FE2rNuWykekJWnDW6qrdSPiUrxoSopNL1c_IipSNjrFGMrcif-wgT_QHTCN46O4UHF-mdd9lBxp5-wHPwPeX0S_D5Jw0D3Y1IIdFDRMgz-nyZfUOfQnQel4vZLULpR7oPKdEWllR8ujNtgx-xGBdFe85hxhEety2p7BvQZhf8O7qjX8H3YXa_C9VOzjtbgEN0ML0kzwaYEr76V2_I908fD-1ttb__fNfu9pWVW56rDkFuQKHuseO8Y1rXoJXu2Fb1AI3kuhMNCKw3sh_EBm2t6_IxrBlvOmFR3pA3V99TDL8WTNnMLlmcJvAYlmREIxouuVK6SOVVamM5NuJgTtHNEM-GM3NJxhzNYzLmkoy5JlOo91cKyxUPDqNJ1qG32LtY_mD64P7L_wWPSpqv</recordid><startdate>202405</startdate><enddate>202405</enddate><creator>Kimberlin, David W.</creator><creator>Aban, Inmaculada</creator><creator>Peri, Kalyani</creator><creator>Nishikawa, Javier K.</creator><creator>Bernatoniene, Jolanta</creator><creator>Emonts, Marieke</creator><creator>Klein, Nigel</creator><creator>Bamford, Alasdair</creator><creator>DeBiasi, Roberta L.</creator><creator>Faust, Saul N.</creator><creator>Jones, Christine E.</creator><creator>McMaster, Paddy</creator><creator>Caserta, Mary</creator><creator>Ahmed, Amina</creator><creator>Sharland, Mike</creator><creator>Demmler-Harrison, Gail</creator><creator>Hackett, Scott</creator><creator>Sánchez, Pablo J.</creator><creator>Shackley, Fiona</creator><creator>Kelly, Dominic</creator><creator>Dennehy, Penelope H.</creator><creator>Storch, Gregory A.</creator><creator>Whitley, Richard J.</creator><creator>Griffiths, Paul</creator><general>Elsevier Inc</general><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202405</creationdate><title>Oral Valganciclovir Initiated Beyond 1 Month of Age as Treatment of Sensorineural Hearing Loss Caused by Congenital Cytomegalovirus Infection: A Randomized Clinical Trial</title><author>Kimberlin, David W. ; Aban, Inmaculada ; Peri, Kalyani ; Nishikawa, Javier K. ; Bernatoniene, Jolanta ; Emonts, Marieke ; Klein, Nigel ; Bamford, Alasdair ; DeBiasi, Roberta L. ; Faust, Saul N. ; Jones, Christine E. ; McMaster, Paddy ; Caserta, Mary ; Ahmed, Amina ; Sharland, Mike ; Demmler-Harrison, Gail ; Hackett, Scott ; Sánchez, Pablo J. ; Shackley, Fiona ; Kelly, Dominic ; Dennehy, Penelope H. ; Storch, Gregory A. ; Whitley, Richard J. ; Griffiths, Paul</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c381t-bea35a4e7deb11b0776a747b084daa9317b29a2e653df25ec676139e6019b2ce3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>antiviral therapy</topic><topic>congenital infection</topic><topic>cytomegalovirus</topic><topic>hearing loss</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kimberlin, David W.</creatorcontrib><creatorcontrib>Aban, Inmaculada</creatorcontrib><creatorcontrib>Peri, Kalyani</creatorcontrib><creatorcontrib>Nishikawa, Javier K.</creatorcontrib><creatorcontrib>Bernatoniene, Jolanta</creatorcontrib><creatorcontrib>Emonts, Marieke</creatorcontrib><creatorcontrib>Klein, Nigel</creatorcontrib><creatorcontrib>Bamford, Alasdair</creatorcontrib><creatorcontrib>DeBiasi, Roberta L.</creatorcontrib><creatorcontrib>Faust, Saul N.</creatorcontrib><creatorcontrib>Jones, Christine E.</creatorcontrib><creatorcontrib>McMaster, Paddy</creatorcontrib><creatorcontrib>Caserta, Mary</creatorcontrib><creatorcontrib>Ahmed, Amina</creatorcontrib><creatorcontrib>Sharland, Mike</creatorcontrib><creatorcontrib>Demmler-Harrison, Gail</creatorcontrib><creatorcontrib>Hackett, Scott</creatorcontrib><creatorcontrib>Sánchez, Pablo J.</creatorcontrib><creatorcontrib>Shackley, Fiona</creatorcontrib><creatorcontrib>Kelly, Dominic</creatorcontrib><creatorcontrib>Dennehy, Penelope H.</creatorcontrib><creatorcontrib>Storch, Gregory A.</creatorcontrib><creatorcontrib>Whitley, Richard J.</creatorcontrib><creatorcontrib>Griffiths, Paul</creatorcontrib><creatorcontrib>Collaborative Antiviral Study Group (CASG)</creatorcontrib><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>The Journal of pediatrics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kimberlin, David W.</au><au>Aban, Inmaculada</au><au>Peri, Kalyani</au><au>Nishikawa, Javier K.</au><au>Bernatoniene, Jolanta</au><au>Emonts, Marieke</au><au>Klein, Nigel</au><au>Bamford, Alasdair</au><au>DeBiasi, Roberta L.</au><au>Faust, Saul N.</au><au>Jones, Christine E.</au><au>McMaster, Paddy</au><au>Caserta, Mary</au><au>Ahmed, Amina</au><au>Sharland, Mike</au><au>Demmler-Harrison, Gail</au><au>Hackett, Scott</au><au>Sánchez, Pablo J.</au><au>Shackley, Fiona</au><au>Kelly, Dominic</au><au>Dennehy, Penelope H.</au><au>Storch, Gregory A.</au><au>Whitley, Richard J.</au><au>Griffiths, Paul</au><aucorp>Collaborative Antiviral Study Group (CASG)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Oral Valganciclovir Initiated Beyond 1 Month of Age as Treatment of Sensorineural Hearing Loss Caused by Congenital Cytomegalovirus Infection: A Randomized Clinical Trial</atitle><jtitle>The Journal of pediatrics</jtitle><date>2024-05</date><risdate>2024</risdate><volume>268</volume><spage>113934</spage><epage>113934</epage><pages>113934-113934</pages><artnum>113934</artnum><issn>0022-3476</issn><eissn>1097-6833</eissn><abstract>The objective of this study was to determine if valganciclovir initiated after 1 month of age improves congenital cytomegalovirus–associated sensorineural hearing loss.
We conducted a randomized, double-blind, placebo-controlled phase 2 trial of 6 weeks of oral valganciclovir at US (n = 12) and UK (n = 9) sites. Patients of ages 1 month through 3 years with baseline sensorineural hearing loss were enrolled. The primary outcome was change in total ear hearing between baseline and study month 6. Secondary outcome measures included change in best ear hearing and reduction in cytomegalovirus viral load in blood, saliva, and urine.
Of 54 participants enrolled, 35 were documented to have congenital cytomegalovirus infection and were randomized (active group: 17; placebo group: 18). Mean age at enrollment was 17.8 ± 15.8 months (valganciclovir) vs 19.5 ± 13.1 months (placebo). Twenty (76.9%) of the 26 ears from subjects in the active treatment group did not have worsening of hearing, compared with 27 (96.4%) of 28 ears from subjects in the placebo group (P = .09). All other comparisons of total ear or best ear hearing outcomes were also not statistically significant. Saliva and urine viral loads decreased significantly in the valganciclovir group but did not correlate with change in hearing outcome.
In this randomized controlled trial, initiation of antiviral therapy beyond the first month of age did not improve hearing outcomes in children with congenital cytomegalovirus–associated sensorineural hearing loss.
ClinicalTrials.gov identifier NCT01649869.</abstract><pub>Elsevier Inc</pub><doi>10.1016/j.jpeds.2024.113934</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0022-3476 |
| ispartof | The Journal of pediatrics, 2024-05, Vol.268, p.113934-113934, Article 113934 |
| issn | 0022-3476 1097-6833 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2929131447 |
| source | ScienceDirect Journals (5 years ago - present) |
| subjects | antiviral therapy congenital infection cytomegalovirus hearing loss |
| title | Oral Valganciclovir Initiated Beyond 1 Month of Age as Treatment of Sensorineural Hearing Loss Caused by Congenital Cytomegalovirus Infection: A Randomized Clinical Trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-12T11%3A57%3A38IST&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=Oral%20Valganciclovir%20Initiated%20Beyond%201%20Month%20of%20Age%20as%20Treatment%20of%20Sensorineural%20Hearing%20Loss%20Caused%20by%20Congenital%20Cytomegalovirus%20Infection:%20A%20Randomized%20Clinical%20Trial&rft.jtitle=The%20Journal%20of%20pediatrics&rft.au=Kimberlin,%20David%20W.&rft.aucorp=Collaborative%20Antiviral%20Study%20Group%20(CASG)&rft.date=2024-05&rft.volume=268&rft.spage=113934&rft.epage=113934&rft.pages=113934-113934&rft.artnum=113934&rft.issn=0022-3476&rft.eissn=1097-6833&rft_id=info:doi/10.1016/j.jpeds.2024.113934&rft_dat=%3Cproquest_cross%3E2929131447%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=2929131447&rft_id=info:pmid/&rft_els_id=S0022347624000374&rfr_iscdi=true |