TY - JOUR
T1 - Novel and optimized diagnostics for pediatric TB in endemic countries NOD-pedFEND study protocol
AU - for the NOD-pedFEND consortium
AU - Song, Rinn
AU - Bijker, Else Margreet
AU - Kisitu, Grace
AU - Douglass, Emily
AU - Nasinghe, Emmanuel
AU - Basile, Francesca Wanda
AU - Khambati, Nisreen
AU - Penn-Nicholson, Adam
AU - Ruhwald, Morten
AU - Kim, Soyeon
AU - Mudrak, Nathan
AU - Dendukuri, Nandini
AU - Ugarte-Gil, César
AU - Salgame, Padmini
AU - Alland, David
AU - Dorman, Susan E.
AU - Ellner, Jerrold
AU - Joloba, Moses
AU - Kekitiinwa, Adeodata
AU - Zamudio, Carlos
AU - Yupanqui, Marjorie
AU - Xie, Yingda
AU - Wobudeya, Eric
AU - Villa, Luz
AU - Upadhyay, Rutvi
AU - Turyamubona, Agnes
AU - Tufariello, Ann
AU - Tagoola, Abner
AU - Sweeney, Sedona
AU - Ssengooba, Willy
AU - Schiller, Ian
AU - Schaaf, H. Simon
AU - Rogers, Kamulegeya
AU - Post, Rebecca
AU - Perez, Gabriela
AU - Palmer, Megan
AU - Olbrich, Laura
AU - Odongo, Israel
AU - Ninsiima, Gloria
AU - Night, Claire
AU - Namaganda, Rose
AU - Nakiyingi, Lydia
AU - Nakayita, Germine
AU - Nakalanda, Brenda Sharon
AU - Nakagwa, Mary
AU - Nabuduwa, Stephannie
AU - Nabisere, Allen
AU - Nabirye, Rose
AU - Mugabi, Benedicto
AU - Egere, Uzochukwu
N1 - Publisher Copyright:
© The Author(s) 2025.
PY - 2025/8/25
Y1 - 2025/8/25
N2 - 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.
AB - 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.
KW - Assays
KW - Children
KW - Cohort
KW - Diagnosis
KW - Tests
KW - Tuberculosis
U2 - 10.1186/s12887-025-05554-3
DO - 10.1186/s12887-025-05554-3
M3 - Article
C2 - 40851094
AN - SCOPUS:105015260968
SN - 1471-2431
VL - 25
JO - BMC Pediatrics
JF - BMC Pediatrics
IS - 1
M1 - 647
ER -
