Towards early inclusion of children in tuberculosis drugs trials: a consensus statement
Summary Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexist...
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| Veröffentlicht in: | The Lancet infectious diseases 2015-06, Vol.15 (6), p.711-720 |
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| creator | Nachman, Sharon, Dr Prof Ahmed, Amina, MD Amanullah, Farhana, MBBS Becerra, Mercedes C, ScD Botgros, Radu, MD Brigden, Grania, MBchB Browning, Renee, MSN Gardiner, Elizabeth, MSc Hafner, Richard, MD Hesseling, Anneke, Prof How, Cleotilde, MD Jean-Philippe, Patrick, MD Lessem, Erica, MPH Makhene, Mamodikoe, MD Mbelle, Nontombi, Prof Marais, Ben, PhD McIlleron, Helen, MBCHb McNeeley, David F, MD Mendel, Carl, MD Murray, Stephen, MD Navarro, Eileen, MD Anyalechi, E Gloria, MD Porcalla, Ariel R, MD Powell, Clydette, MD Powell, Mair, MD Rigaud, Mona, MD Rouzier, Vanessa, MD Samson, Pearl, MS Schaaf, H Simon, Prof Shah, Seema, JD Starke, Jeff, Prof Swaminathan, Soumya, MD Wobudeya, Eric, MD Worrell, Carol, MD |
| description | Summary Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained. |
| doi_str_mv | 10.1016/S1473-3099(15)00007-9 |
| format | Article |
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Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained.</description><identifier>ISSN: 1473-3099</identifier><identifier>EISSN: 1474-4457</identifier><identifier>DOI: 10.1016/S1473-3099(15)00007-9</identifier><identifier>PMID: 25957923</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>United States: Elsevier Ltd</publisher><subject>Acquired immune deficiency syndrome ; Adolescent ; Adult ; Age Factors ; AIDS ; Antitubercular Agents - therapeutic use ; Child ; Child, Preschool ; Clinical Trials as Topic ; Consensus ; Drug resistance ; Drug therapy ; Female ; HIV ; Human immunodeficiency virus ; Humans ; Infant ; Infant, Newborn ; Infectious Disease ; Infectious diseases ; Male ; Medical research ; Opinion leaders ; Studies ; Tuberculosis ; Tuberculosis - drug therapy</subject><ispartof>The Lancet infectious diseases, 2015-06, Vol.15 (6), p.711-720</ispartof><rights>Elsevier Ltd</rights><rights>2015 Elsevier Ltd</rights><rights>Copyright © 2015 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Jun 2015</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c565t-180e299e6df8f15cd7f4addd822912cf8f0fc14db52081724903657e45c329083</citedby><cites>FETCH-LOGICAL-c565t-180e299e6df8f15cd7f4addd822912cf8f0fc14db52081724903657e45c329083</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1473309915000079$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25957923$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nachman, Sharon, Dr Prof</creatorcontrib><creatorcontrib>Ahmed, Amina, MD</creatorcontrib><creatorcontrib>Amanullah, Farhana, MBBS</creatorcontrib><creatorcontrib>Becerra, Mercedes C, ScD</creatorcontrib><creatorcontrib>Botgros, Radu, MD</creatorcontrib><creatorcontrib>Brigden, Grania, MBchB</creatorcontrib><creatorcontrib>Browning, Renee, MSN</creatorcontrib><creatorcontrib>Gardiner, Elizabeth, MSc</creatorcontrib><creatorcontrib>Hafner, Richard, MD</creatorcontrib><creatorcontrib>Hesseling, Anneke, Prof</creatorcontrib><creatorcontrib>How, Cleotilde, MD</creatorcontrib><creatorcontrib>Jean-Philippe, Patrick, MD</creatorcontrib><creatorcontrib>Lessem, Erica, MPH</creatorcontrib><creatorcontrib>Makhene, Mamodikoe, MD</creatorcontrib><creatorcontrib>Mbelle, Nontombi, Prof</creatorcontrib><creatorcontrib>Marais, Ben, PhD</creatorcontrib><creatorcontrib>McIlleron, Helen, MBCHb</creatorcontrib><creatorcontrib>McNeeley, David F, MD</creatorcontrib><creatorcontrib>Mendel, Carl, MD</creatorcontrib><creatorcontrib>Murray, Stephen, MD</creatorcontrib><creatorcontrib>Navarro, Eileen, MD</creatorcontrib><creatorcontrib>Anyalechi, E Gloria, MD</creatorcontrib><creatorcontrib>Porcalla, Ariel R, MD</creatorcontrib><creatorcontrib>Powell, Clydette, MD</creatorcontrib><creatorcontrib>Powell, Mair, MD</creatorcontrib><creatorcontrib>Rigaud, Mona, MD</creatorcontrib><creatorcontrib>Rouzier, Vanessa, MD</creatorcontrib><creatorcontrib>Samson, Pearl, MS</creatorcontrib><creatorcontrib>Schaaf, H Simon, Prof</creatorcontrib><creatorcontrib>Shah, Seema, JD</creatorcontrib><creatorcontrib>Starke, Jeff, Prof</creatorcontrib><creatorcontrib>Swaminathan, Soumya, MD</creatorcontrib><creatorcontrib>Wobudeya, Eric, MD</creatorcontrib><creatorcontrib>Worrell, Carol, MD</creatorcontrib><title>Towards early inclusion of children in tuberculosis drugs trials: a consensus statement</title><title>The Lancet infectious diseases</title><addtitle>Lancet Infect Dis</addtitle><description>Summary Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained.</description><subject>Acquired immune deficiency syndrome</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Age Factors</subject><subject>AIDS</subject><subject>Antitubercular Agents - therapeutic use</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Clinical Trials as Topic</subject><subject>Consensus</subject><subject>Drug resistance</subject><subject>Drug therapy</subject><subject>Female</subject><subject>HIV</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Infectious Disease</subject><subject>Infectious diseases</subject><subject>Male</subject><subject>Medical research</subject><subject>Opinion 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MD</au><au>Wobudeya, Eric, MD</au><au>Worrell, Carol, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Towards early inclusion of children in tuberculosis drugs trials: a consensus statement</atitle><jtitle>The Lancet infectious diseases</jtitle><addtitle>Lancet Infect Dis</addtitle><date>2015-06-01</date><risdate>2015</risdate><volume>15</volume><issue>6</issue><spage>711</spage><epage>720</epage><pages>711-720</pages><issn>1473-3099</issn><eissn>1474-4457</eissn><coden>LANCAO</coden><abstract>Summary Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained.</abstract><cop>United States</cop><pub>Elsevier Ltd</pub><pmid>25957923</pmid><doi>10.1016/S1473-3099(15)00007-9</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1473-3099 |
| ispartof | The Lancet infectious diseases, 2015-06, Vol.15 (6), p.711-720 |
| issn | 1473-3099 1474-4457 |
| language | eng |
| recordid | cdi_proquest_journals_1681649094 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Acquired immune deficiency syndrome Adolescent Adult Age Factors AIDS Antitubercular Agents - therapeutic use Child Child, Preschool Clinical Trials as Topic Consensus Drug resistance Drug therapy Female HIV Human immunodeficiency virus Humans Infant Infant, Newborn Infectious Disease Infectious diseases Male Medical research Opinion leaders Studies Tuberculosis Tuberculosis - drug therapy |
| title | Towards early inclusion of children in tuberculosis drugs trials: a consensus statement |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-01T16%3A33%3A20IST&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=Towards%20early%20inclusion%20of%20children%20in%20tuberculosis%20drugs%20trials:%20a%20consensus%20statement&rft.jtitle=The%20Lancet%20infectious%20diseases&rft.au=Nachman,%20Sharon,%20Dr%20Prof&rft.date=2015-06-01&rft.volume=15&rft.issue=6&rft.spage=711&rft.epage=720&rft.pages=711-720&rft.issn=1473-3099&rft.eissn=1474-4457&rft.coden=LANCAO&rft_id=info:doi/10.1016/S1473-3099(15)00007-9&rft_dat=%3Cproquest_cross%3E3688687591%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=1681649094&rft_id=info:pmid/25957923&rft_els_id=1_s2_0_S1473309915000079&rfr_iscdi=true |