Evidence map›Paper›PMID 25957923›Full record

ReviewThe Lancet. Infectious diseases2015

Towards early inclusion of children in tuberculosis drugs trials: a consensus statement.

Sharon Nachman, Amina Ahmed, Farhana Amanullah, Mercedes C Becerra, Radu Botgros, Grania Brigden, Renee Browning, Elizabeth Gardiner, Richard Hafner, Anneke Hesseling and 24 more

Abstract readReviewConsensus Statement
In one paragraph

Review in The Lancet. Infectious diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed.

  1. Journal of child health care : for professionals working with children in the hospital and community · 2022
    Trial
  2. Review
  3. Review
  4. Review
  5. Review
  6. Target regimen profiles for tuberculosis treatment.Bulletin of the World Health Organization · 2024
    Article
  7. Facilitators and barriers to adolescent participation in a TB clinical trial.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2024
    Article
  8. Article
  9. Caring for Adolescents and Young Adults With Tuberculosis or at Risk of Tuberculosis: Consensus Statement From an International Expert Panel.The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 2023
    Article
  10. Review
  11. Paediatric formulations for the treatment of drug resistant TB: closing the gaps.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2022
    Article
  12. Article
  13. Article
  14. Review
  15. Acceptability of a first-line anti-tuberculosis formulation for children: qualitative data from the SHINE trial.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2019
    Article
  16. Article
  17. Management and outcomes of severe childhood tuberculosis in the pediatric intensive care setting: can we identify best practices?Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2019
    Article
  18. Multiparameter Responses to Tedizolid Monotherapy and Moxifloxacin Combination Therapy Models of Children With Intracellular Tuberculosis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018
    Article
  19. Tuberculosis in Children.Pediatric clinics of North America · 2017
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

34 authors.

Sharon NachmanSUNY at Stony Brook, Stony Brook, NY, USA. Electronic address: sharon.nachman@stonybrook.edu.
Amina AhmedLevine Children's Hospital at Carolinas Medical Center, Charlotte, NC, USA.
Farhana AmanullahIndus Hospital, Pakistan.
Mercedes C BecerraHarvard Medical School, Boston, MA, USA.
Radu BotgrosEuropean Medicines Agency, London, UK.
Grania BrigdenMédecins Sans Frontières, Access Campaign, Geneva, Switzerland.
Renee BrowningNational Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS, Bethesda, MD, USA.
Elizabeth GardinerTB Alliance, New York, NY, USA.
Richard HafnerNational Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS, Bethesda, MD, USA.
Anneke HesselingDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Cape Town, South Africa.
Cleotilde HowDepartment of Pharmacology and Toxicology, University of the Philippines, Manila, Philippines.
Patrick Jean-PhilippeHenry 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.
Erica LessemTreatment Action Group, New York, NY, USA.
Mamodikoe MakheneNational Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS, Bethesda, MD, USA.
Nontombi MbelleDepartment of Medical Microbiology, University of Pretoria, Pretoria, South Africa.
Ben MaraisMarie 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.
Helen McIlleronDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, South Africa.
David F McNeeleyNovartis Pharmaceuticals, East Hanover, NJ, USA.
Carl MendelTB Alliance, New York, NY, USA.
Stephen MurrayTB Alliance, New York, NY, USA.
Eileen NavarroDivision 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.
E Gloria AnyalechiUS Centers for Disease Control and Prevention, Division of Tuberculosis Elimination, International Research and Programs Branch, Atlanta, GA, USA.
Ariel R PorcallaDivision 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.
Clydette PowellUS Agency for International Development, Washington, DC, USA.
Mair PowellEuropean Medicines Agency, London, UK.
Mona RigaudNew York University School of Medicine, NY, USA.
Vanessa RouzierGHESKIO, Port-au-Prince, Haiti.
Pearl SamsonStatistical and Data Analysis Center, Center for Biostatistics in AIDS Research and Frontier Science, Harvard School of Public Health, Boston, MA, USA.
H Simon SchaafDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Cape Town, South Africa.
Seema ShahDepartment of Bioethics, NIH Clinical Center, Bethesda, MD, USA.
Jeff StarkeBaylor College of Medicine, Houston, TX, USA.
Soumya SwaminathanNational Institute for Research in Tuberculosis, Chennai, India.
Eric WobudeyaMakerere University Johns Hopkins Research Collaboration, and Mulago National Referral Hospital, Kampala, Uganda.
Carol WorrellEunice Kennedy Schriver National Institute of Child Health and Human Development, National Institutes of Health, Rockville, MD, USA.

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
Medical Research Council MR/M007340/1NIAID NIH HHS HHSN272200800014CNIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632
6 · The paper itself

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.

Indexed as

Clinical Trials as TopicAdolescentAdultAge FactorsAntitubercular AgentsChildChild, PreschoolConsensusFemaleHumansInfantInfant, NewbornMaleTuberculosisAntitubercular Agents

Identifiers

PMID25957923
PMCPMC4471052

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.