Evaluation of Xpert MTB/RIF Ultra in Stools and Urine to Improve Tuberculosis Diagnosis in Children

NCT06239337 | Completed DMC

• 1 other identifier: MSF18115
• Study Type: observational
• Target: 563
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Tuberculosis; Pediatric Infectious Disease

Keywords

Pediatric TB; Xpert MTB/RIF Ultra; Stools; Urine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Interventions

Xpert MTB/RIF Ultra in stools and urine DIAGNOSTIC_TEST

All children with presumptive TB had at least 1 sample collected of respiratory or extrapulmonary specimen (considered as gold standard) and 1 sample of stools and 1 sample of urine. All of them were analyzed with Xpert MTB/RIF Ultra.

Eligibility Criteria

• Age: 6 Months - 15 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The research population are children with presumptive TB at Malakal hospitals (South Sudan) at Simão Mendes National Hospital (Guinea-Bissau).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medecins Sans Frontieres, Spain: lead
• Ministry of Health, Guinea-Bissau: collaborator
• Ministry of Health, South Sudan: collaborator
• Institute of Tropical Medicine, University of Tuebingen: collaborator

Study Sites (2)

Simao Mendes hospital

Bissau, Guinea-Bissau

Location

Malakal hospital

Malakal, Upper Nile, South Sudan

Location

Related Publications (10)

• 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.

  PMID: 27964822 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 28115682 BACKGROUND

• 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/

  PMID: 35404556 BACKGROUND

• 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.

  PMID: 36065889 BACKGROUND

• 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.

  PMID: 30873392 BACKGROUND

• 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.

  PMID: 33743621 BACKGROUND

• 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.

  PMID: 32421765 BACKGROUND

• 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.

  PMID: 34774781 BACKGROUND

• Moreto-Planas L, Mahajan R, Fidelle Nyikayo L, Ajack YBP, Tut Chol B, Osman E, Sangma M, Tobi A, Gallo J, Biague E, Goncalves R, Rocaspana M, Medina C, Camara M, Flevaud L, Ruby LC, Belard S, Sagrado MJ, Molina I, Llosa AE. Xpert-Ultra Assay in Stool and Urine Samples to Improve Tuberculosis Diagnosis in Children: The Medecins Sans Frontieres Experience in Guinea-Bissau and South Sudan. Open Forum Infect Dis. 2024 May 2;11(5):ofae221. doi: 10.1093/ofid/ofae221. eCollection 2024 May.

  PMID: 38798893 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Respiratory, extrapulmonary, stools and urine specimens for Xpert MTB/RIF Ultra. Urine for TB LAM.

MeSH Terms

Conditions

Tuberculosis

Interventions

Defecation; Urination

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Laura Moretó Planas, MD

  MSF OCBA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 2, 2024
• Study Start: June 26, 2019
• Primary Completion: June 1, 2023
• Study Completion: December 15, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1); SO (1)