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Towards early inclusion of children in tuberculosis drugs trials: a consensus statement.
Nachman, Sharon; Ahmed, Amina; Amanullah, Farhana; Becerra, Mercedes C; Botgros, Radu; Brigden, Grania; Browning, Renee; Gardiner, Elizabeth; Hafner, Richard; Hesseling, Anneke; How, Cleotilde; Jean-Philippe, Patrick; Lessem, Erica; Makhene, Mamodikoe; Mbelle, Nontombi; Marais, Ben; McIlleron, Helen; McNeeley, David F; Mendel, Carl; Murray, Stephen; Navarro, Eileen; Anyalechi, E Gloria; Porcalla, Ariel R; Powell, Clydette; Powell, Mair; Rigaud, Mona; Rouzier, Vanessa; Samson, Pearl; Schaaf, H Simon; Shah, Seema; Starke, Jeff; Swaminathan, Soumya; Wobudeya, Eric; Worrell, Carol.
Afiliação
  • Nachman S; SUNY at Stony Brook, Stony Brook, NY, USA. Electronic address: sharon.nachman@stonybrook.edu.
  • Ahmed A; Levine Children's Hospital at Carolinas Medical Center, Charlotte, NC, USA.
  • Amanullah F; Indus Hospital, Pakistan.
  • Becerra MC; Harvard Medical School, Boston, MA, USA.
  • Botgros R; European Medicines Agency, London, UK.
  • Brigden G; Médecins Sans Frontières, Access Campaign, Geneva, Switzerland.
  • Browning R; National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS, Bethesda, MD, USA.
  • Gardiner E; TB Alliance, New York, NY, USA.
  • Hafner R; National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS, Bethesda, MD, USA.
  • Hesseling A; Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Cape Town, South Africa.
  • How C; Department of Pharmacology and Toxicology, University of the Philippines, Manila, Philippines.
  • Jean-Philippe P; Henry M Jackson Foundation-Division of AIDS, Contractor to National Institutes of Health, National Institute of Allergy and Infectious Diseases, Department of Health and Human Services, Bethesda, MD, USA.
  • Lessem E; Treatment Action Group, New York, NY, USA.
  • Makhene M; National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS, Bethesda, MD, USA.
  • Mbelle N; Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa.
  • Marais B; Marie Bashir Institute for Infectious Diseases and Biosecurity and the Sydney Emerging Infectious Diseases and Biosecurity Institute and The Children's Hospital at Westmead, Sydney Medical School, University of Sydney, Sydney, Australia.
  • McIlleron H; Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, South Africa.
  • McNeeley DF; Novartis Pharmaceuticals, East Hanover, NJ, USA.
  • Mendel C; TB Alliance, New York, NY, USA.
  • Murray S; TB Alliance, New York, NY, USA.
  • Navarro E; Division of Anti-Infective Products; Office of Antimicrobial Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Anyalechi EG; US Centers for Disease Control and Prevention, Division of Tuberculosis Elimination, International Research and Programs Branch, Atlanta, GA, USA.
  • Porcalla AR; Division of Anti-Infective Products; Office of Antimicrobial Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Powell C; US Agency for International Development, Washington, DC, USA.
  • Powell M; European Medicines Agency, London, UK.
  • Rigaud M; New York University School of Medicine, NY, USA.
  • Rouzier V; GHESKIO, Port-au-Prince, Haiti.
  • Samson P; Statistical and Data Analysis Center, Center for Biostatistics in AIDS Research and Frontier Science, Harvard School of Public Health, Boston, MA, USA.
  • Schaaf HS; Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Cape Town, South Africa.
  • Shah S; Department of Bioethics, NIH Clinical Center, Bethesda, MD, USA.
  • Starke J; Baylor College of Medicine, Houston, TX, USA.
  • Swaminathan S; National Institute for Research in Tuberculosis, Chennai, India.
  • Wobudeya E; Makerere University Johns Hopkins Research Collaboration, and Mulago National Referral Hospital, Kampala, Uganda.
  • Worrell C; Eunice Kennedy Schriver National Institute of Child Health and Human Development, National Institutes of Health, Rockville, MD, USA.
Lancet Infect Dis ; 15(6): 711-20, 2015 Jun.
Article em En | MEDLINE | ID: mdl-25957923
ABSTRACT
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.
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Texto completo: 1 Coleções: 01-internacional Contexto em Saúde: 3_ND Base de dados: MEDLINE Assunto principal: Tuberculose / Ensaios Clínicos como Assunto / Antituberculosos Tipo de estudo: Guideline Limite: Adolescent / Adult / Child / Child, preschool / Female / Humans / Infant / Male / Newborn Idioma: En Revista: Lancet Infect Dis Ano de publicação: 2015 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Contexto em Saúde: 3_ND Base de dados: MEDLINE Assunto principal: Tuberculose / Ensaios Clínicos como Assunto / Antituberculosos Tipo de estudo: Guideline Limite: Adolescent / Adult / Child / Child, preschool / Female / Humans / Infant / Male / Newborn Idioma: En Revista: Lancet Infect Dis Ano de publicação: 2015 Tipo de documento: Article