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Background <p>Pediatric tuberculosis is a major global public health challenge, with reliable diagnosis being a main obstacle to identifying and treating affected children. New and improved diagnostics, ideally on non-sputum samples, are urgently required, especially in the most vulnerable group of children under five years of age. Studies to date have been limited by small sample sizes and few bacteriologically-confirmed cases. Here, we describe the study protocol of the NIH-funded NOD-pedFEND study, which will be one of the largest diagnostic studies to date of children at greatest risk of tuberculosis.</p> Methods <p>In this prospective observational cohort study, we aim to evaluate existing and novel diagnostic assays, including pathogen- and host-based tests and combinations of tests. A consecutive cohort of children under five years of age with signs and symptoms of tuberculosis is enrolled in Uganda and Peru. All children undergo an extensive baseline workup with signs- and symptoms recording, microbiological reference tests, chest X-ray and tuberculin skin test for rigorous classification according to internationally recognized microbiological, composite reference and strict standards. An array of samples is collected for investigational tests. Follow-up visits are conducted at 2&#xa0;weeks, 2&#xa0;months and 6&#xa0;months. A small cohort of healthy controls is enrolled to evaluate the specificity of selected diagnostics. The study has been approved by the relevant institutional review boards.</p> Discussion <p>With this large cohort study of children under five years of age, we aim to make an important contribution to the evaluation of new diagnostics for pediatric tuberculosis. By establishing a comprehensive biorepository, the study will also enable the assessment of novel tests as they become available during and after the study.</p>

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Novel and optimized diagnostics for pediatric TB in endemic countries: NOD-pedFEND study protocol

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年8月25日

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  • Rinn Song,
  • Else Margreet Bijker,
  • Grace Kisitu,
  • Emily Douglass,
  • Emmanuel Nasinghe,
  • Francesca Wanda Basile,
  • Nisreen Khambati,
  • Adam Penn-Nicholson,
  • Morten Ruhwald,
  • Soyeon Kim,
  • Nathan Mudrak,
  • Nandini Dendukuri,
  • César Ugarte-Gil,
  • Padmini Salgame,
  • David Alland,
  • Susan E. Dorman,
  • Jerrold Ellner,
  • Moses Joloba,
  • Adeodata Kekitiinwa,
  • Gerald Agaba Muzorah,
  • Gideon Ahimbisibwe,
  • Sharley Aloyo,
  • Sheillah Ansiima,
  • Derek Armstrong,
  • Kiranjot Arora,
  • Sandra Ruth Babirye,
  • Henry Balwa,
  • Kisegerwa Bashir,
  • April Borkman,
  • Eric Bugumirwa,
  • Tatiana Caceres,
  • Rodrigo Calderon,
  • Andrea Cavallini,
  • Ted Cohen,
  • Margaretha De Vos,
  • Uzochukwu Egere,
  • Christie Eichberg,
  • Karla Giannina Ali Francia,
  • Steve M. Graham,
  • George Haumba,
  • David Hom,
  • Pitchaya Peach Indravudh,
  • Farag Kakyama,
  • Florence Kalawa,
  • Angel Kanyange,
  • Samuel Kasibante,
  • Nakitto Aisha Kawwoya,
  • Sandra V. Kik,
  • Malik Koire,
  • Daisy Kyamulabi,
  • Yhanela Lagos,
  • Nair Lovaton,
  • John Paul Lubega,
  • Rose Nabatanzi,
  • Agnes Malobela,
  • Ben J. Marais,
  • Frank Matovu,
  • Prossy Mbekeka,
  • Nicolas Menzies,
  • Francisco Mestanza,
  • Angella Mirembe,
  • Carolina Moron,
  • Rita Makabayi Mugabe,
  • Benedicto Mugabi,
  • Rose Nabirye,
  • Allen Nabisere,
  • Stephannie Nabuduwa,
  • Mary Nakagwa,
  • Brenda Sharon Nakalanda,
  • Germine Nakayita,
  • Lydia Nakiyingi,
  • Rose Namaganda,
  • Claire Night,
  • Gloria Ninsiima,
  • Israel Odongo,
  • Laura Olbrich,
  • Megan Palmer,
  • Gabriela Perez,
  • Rebecca Post,
  • Kamulegeya Rogers,
  • H. Simon Schaaf,
  • Ian Schiller,
  • Willy Ssengooba,
  • Sedona Sweeney,
  • Abner Tagoola,
  • Ann Tufariello,
  • Agnes Turyamubona,
  • Rutvi Upadhyay,
  • Luz Villa,
  • Eric Wobudeya,
  • Yingda Xie,
  • Marjorie Yupanqui,
  • Carlos Zamudio

摘要

Background

Pediatric tuberculosis is a major global public health challenge, with reliable diagnosis being a main obstacle to identifying and treating affected children. New and improved diagnostics, ideally on non-sputum samples, are urgently required, especially in the most vulnerable group of children under five years of age. Studies to date have been limited by small sample sizes and few bacteriologically-confirmed cases. Here, we describe the study protocol of the NIH-funded NOD-pedFEND study, which will be one of the largest diagnostic studies to date of children at greatest risk of tuberculosis.

Methods

In this prospective observational cohort study, we aim to evaluate existing and novel diagnostic assays, including pathogen- and host-based tests and combinations of tests. A consecutive cohort of children under five years of age with signs and symptoms of tuberculosis is enrolled in Uganda and Peru. All children undergo an extensive baseline workup with signs- and symptoms recording, microbiological reference tests, chest X-ray and tuberculin skin test for rigorous classification according to internationally recognized microbiological, composite reference and strict standards. An array of samples is collected for investigational tests. Follow-up visits are conducted at 2 weeks, 2 months and 6 months. A small cohort of healthy controls is enrolled to evaluate the specificity of selected diagnostics. The study has been approved by the relevant institutional review boards.

Discussion

With this large cohort study of children under five years of age, we aim to make an important contribution to the evaluation of new diagnostics for pediatric tuberculosis. By establishing a comprehensive biorepository, the study will also enable the assessment of novel tests as they become available during and after the study.