Tuberculosis Clinical Trial
Official title:
Evaluation of Xpert MTB/RIF Ultra in Stools and Urine to Improve Tuberculosis Diagnosis in Children
NCT number | NCT06239337 |
Other study ID # | MSF18115 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 26, 2019 |
Est. completion date | December 15, 2023 |
Verified date | January 2024 |
Source | Medecins Sans Frontieres, Spain |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Tuberculosis (TB) diagnosis in children is challenging in low and middle-income countries where access to TB culture and X-ray is limited. More than half cases of childhood TB remain undiagnosed every year. A delay in TB diagnosis can lead to an increase in preventable morbidity and mortality. This study aims to provide evidence on the diagnostic accuracy of Xpert MTB/RIF Ultra in stools and urine for TB diagnosis in children.
Status | Completed |
Enrollment | 563 |
Est. completion date | December 15, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 6 Months to 15 Years |
Eligibility | Inclusion Criteria: - Any child from 6 months of life to 15 years old - TB suspected according to diagnostic criteria - Informed consent provided by legal responsible or companion Exclusion Criteria: - Patients who have received TB treatment for > 1 day in the last 3 months - Patients not producing stools or urine during period of admission and prior to starting TB drugs |
Country | Name | City | State |
---|---|---|---|
Guinea-Bissau | Simao Mendes hospital | Bissau | |
South Sudan | Malakal hospital | Malakal | Upper Nile |
Lead Sponsor | Collaborator |
---|---|
Medecins Sans Frontieres, Spain | Institute of Tropical Medicine, University of Tuebingen, Ministry of Health, Guinea-Bissau, Ministry of Health, South Sudan |
Guinea-Bissau, South Sudan,
Atherton RR, Cresswell FV, Ellis J, Kitaka SB, Boulware DR. Xpert MTB/RIF Ultra for Tuberculosis Testing in Children: A Mini-Review and Commentary. Front Pediatr. 2019 Feb 28;7:34. doi: 10.3389/fped.2019.00034. eCollection 2019. — View Citation
Dodd PJ, Prendergast AJ, Beecroft C, Kampmann B, Seddon JA. The impact of HIV and antiretroviral therapy on TB risk in children: a systematic review and meta-analysis. Thorax. 2017 Jun;72(6):559-575. doi: 10.1136/thoraxjnl-2016-209421. Epub 2017 Jan 23. — View Citation
Jenkins HE, Yuen CM, Rodriguez CA, Nathavitharana RR, McLaughlin MM, Donald P, Marais BJ, Becerra MC. Mortality in children diagnosed with tuberculosis: a systematic review and meta-analysis. Lancet Infect Dis. 2017 Mar;17(3):285-295. doi: 10.1016/S1473-3099(16)30474-1. Epub 2016 Dec 8. — View Citation
Kabir S, Rahman SMM, Ahmed S, Islam MS, Banu RS, Shewade HD, Thekkur P, Anwar S, Banu NA, Nasrin R, Uddin MKM, Choudhury S, Ahmed S, Paul KK, Khatun R, Chisti MJ, Banu S. Xpert Ultra Assay on Stool to Diagnose Pulmonary Tuberculosis in Children. Clin Infect Dis. 2021 Jul 15;73(2):226-234. doi: 10.1093/cid/ciaa583. — View Citation
Kay AW, Ness T, Verkuijl SE, Viney K, Brands A, Masini T, Gonzalez Fernandez L, Eisenhut M, Detjen AK, Mandalakas AM, Steingart KR, Takwoingi Y. Xpert MTB/RIF Ultra assay for tuberculosis disease and rifampicin resistance in children. Cochrane Database Syst Rev. 2022 Sep 6;9(9):CD013359. doi: 10.1002/14651858.CD013359.pub3. — View Citation
POSEE Info Note_Pediatric TB diagnosis_Final_17.6.2021.pdf. Taskforce PTOaSEEP. Summary guidance for Microbiological and Clinical Diagnosis of pulmonary tuberculosis among Children: Pediatric TB Operational and Sustainability Expertise Exchange (POSEE) Taskforce, 2021.
Sun L, Liu Y, Fang M, Chen Y, Zhu Y, Xia C, Jia J, Quan S, Wang Y, Tian X, Shi Y, Duan L, Shi X, Liao Q, Wan C, Shen A. Use of Xpert MTB/RIF Ultra assay on stool and gastric aspirate samples to diagnose pulmonary tuberculosis in children in a high-tuberculosis-burden but resource-limited area of China. Int J Infect Dis. 2022 Jan;114:236-243. doi: 10.1016/j.ijid.2021.11.012. Epub 2021 Nov 10. — View Citation
Vessiere A, Font H, Gabillard D, Adonis-Koffi L, Borand L, Chabala C, Khosa C, Mavale S, Moh R, Mulenga V, Mwanga-Amumpere J, Taguebue JV, Eang MT, Delacourt C, Seddon JA, Lounnas M, Godreuil S, Wobudeya E, Bonnet M, Marcy O. Impact of systematic early tuberculosis detection using Xpert MTB/RIF Ultra in children with severe pneumonia in high tuberculosis burden countries (TB-Speed pneumonia): a stepped wedge cluster randomized trial. BMC Pediatr. 2021 Mar 20;21(1):136. doi: 10.1186/s12887-021-02576-5. — View Citation
WHO consolidated guidelines on tuberculosis: Module 5: Management of tuberculosis in children and adolescents [Internet]. Geneva: World Health Organization; 2022. Available from http://www.ncbi.nlm.nih.gov/books/NBK579387/ — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the sensitivity and specificity of Xpert MTB/RIF Ultra in stool and urine samples in presumptive TB pediatric cases in comparison to Xpert MTB/RIF Ultra in respiratory/extrapulmonary sample | To determine the sensitivity and specificity of Xpert MTB/RIF Ultra in stool and urine samples in presumptive TB pediatric cases in comparison to Xpert MTB/RIF Ultra in respiratory/extrapulmonary sample | Through study completion, up to 60 months | |
Secondary | To determine sensitivity and specificity of Xpert MTB/RIF Ultra in stool and urine samples in subpopulations: HIV/not HIV, SAM/no SAM, <5 years old vs. 5 or more years old. | To determine sensitivity and specificity of Xpert MTB/RIF Ultra in stool and urine samples in subpopulations: HIV/not HIV, SAM/no SAM, <5 years old vs. 5 or more years old. | Through study completion, up to 60 months | |
Secondary | To determine the added diagnostic yield of Xpert MTB/RIF Ultra in stool and urine samples when gold standard is negative | To determine the added diagnostic yield of Xpert MTB/RIF Ultra in stool and urine samples when gold standard is negative | Through study completion, up to 60 months |
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