Evaluation of Point-of-care Ultrasound in Children From 6 Months to 15 Years With Presumptive Tuberculosis

NCT05364593 | Completed DMC

• 1 other identifier: MSF18116
• Study Type: observational
• Target: 576
• Locations: 2 countries
• Sites: 2

Brief Summary

Diagnosis of tuberculosis (TB) in children is particularly challenging in low and middle-income countries (LMIC), and a high number of children remain undiagnosed and untreated. A delay in diagnosis can lead to an increase in preventable morbidity and mortality. Point-of-care ultrasound (POCUS) is a bedside, non-invasive, inexpensive imaging tool, and TB-focused POCUS has been used and validated for adults with HIV. This study aims to describe the TB-focused POCUS findings for children with presumptive TB aged between 6 months and 15 years old, and to stratify the results per HIV, nutritional status and age. This is a Médecins Sans Frontières (MSF) multicentric study which takes place in Guinea Bissau and South Sudan.

Conditions

Tuberculosis

Keywords

Tuberculosis; Point of care ultrasound; FASH

Outcome Measures

Primary Outcomes (1)

• To describe the sonographic findings obtained by TB-focused POCUS methodology

  To describe the sonographic findings obtained by TB-focused POCUS methodology for pulmonary and extra-pulmonary tuberculosis in children per TB category

  At baseline

Secondary Outcomes (7)

• To establish the sensitivity, specificity, positive predictive value and negative predictive value of POCUS positive as a composite against a composite reference of the final diagnosis

  At baseline

• To describe the sonographic signs according to HIV status (positive, negative)

  At baseline

• To describe the sonographic signs according to nutritional status (severe acute malnutrition (SAM) or not SAM)

  At baseline

• To determine the proportion of children with improvement / resolution of sonographic signs and the proportion without improvement of sonographic signs at 2 months of follow-up in children with and without TB

  At 2 months

• To describe operational aspects of POCUS: compliance

  At baseline

Eligibility Criteria

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

Study Population

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

You may qualify if:

• Any child from 6 months of life to 15 years old
• Presumptive TB 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
• Informed consent not provided by legal responsible or companion

Sponsors & Collaborators

• Medecins Sans Frontieres, Spain: lead

Study Sites (2)

Simao Mendes Hospital

Bissau, Guinea-Bissau

Location

Malakal hospital

Malakal, Upper Nile, South Sudan

Location

Related Publications (18)

• Mwangwa F, Chamie G, Kwarisiima D, Ayieko J, Owaraganise A, Ruel TD, Plenty A, Tram KH, Clark TD, Cohen CR, Bukusi EA, Petersen M, Kamya MR, Charlebois ED, Havlir DV, Marquez C. Gaps in the Child Tuberculosis Care Cascade in 32 Rural Communities in Uganda and Kenya. J Clin Tuberc Other Mycobact Dis. 2017 Dec;9:24-29. doi: 10.1016/j.jctube.2017.10.003.

  PMID: 29291251 BACKGROUND

• Chisti MJ, Ahmed T, Pietroni MA, Faruque AS, Ashraf H, Bardhan PK, Hossain I, Das SK, Salam MA. Pulmonary tuberculosis in severely-malnourished or HIV-infected children with pneumonia: a review. J Health Popul Nutr. 2013 Sep;31(3):308-13. doi: 10.3329/jhpn.v31i3.16516.

  PMID: 24288943 BACKGROUND

• Jaganath D, Mupere E. Childhood tuberculosis and malnutrition. J Infect Dis. 2012 Dec 15;206(12):1809-15. doi: 10.1093/infdis/jis608. Epub 2012 Oct 2.

  PMID: 23033147 BACKGROUND

• Graham SM, Ahmed T, Amanullah F, Browning R, Cardenas V, Casenghi M, Cuevas LE, Gale M, Gie RP, Grzemska M, Handelsman E, Hatherill M, Hesseling AC, Jean-Philippe P, Kampmann B, Kabra SK, Lienhardt C, Lighter-Fisher J, Madhi S, Makhene M, Marais BJ, McNeeley DF, Menzies H, Mitchell C, Modi S, Mofenson L, Musoke P, Nachman S, Powell C, Rigaud M, Rouzier V, Starke JR, Swaminathan S, Wingfield C. Evaluation of tuberculosis diagnostics in children: 1. Proposed clinical case definitions for classification of intrathoracic tuberculosis disease. Consensus from an expert panel. J Infect Dis. 2012 May 15;205 Suppl 2(Suppl 2):S199-208. doi: 10.1093/infdis/jis008. Epub 2012 Mar 22.

  PMID: 22448023 BACKGROUND

• Belard S, Tamarozzi F, Bustinduy AL, Wallrauch C, Grobusch MP, Kuhn W, Brunetti E, Joekes E, Heller T. Point-of-Care Ultrasound Assessment of Tropical Infectious Diseases--A Review of Applications and Perspectives. Am J Trop Med Hyg. 2016 Jan;94(1):8-21. doi: 10.4269/ajtmh.15-0421. Epub 2015 Sep 28.

  PMID: 26416111 BACKGROUND

• Bobbio F, Di Gennaro F, Marotta C, Kok J, Akec G, Norbis L, Monno L, Saracino A, Mazzucco W, Lunardi M. Focused ultrasound to diagnose HIV-associated tuberculosis (FASH) in the extremely resource-limited setting of South Sudan: a cross-sectional study. BMJ Open. 2019 Apr 2;9(4):e027179. doi: 10.1136/bmjopen-2018-027179.

  PMID: 30944140 BACKGROUND

• Heller T, Wallrauch C, Goblirsch S, Brunetti E. Focused assessment with sonography for HIV-associated tuberculosis (FASH): a short protocol and a pictorial review. Crit Ultrasound J. 2012 Nov 21;4(1):21. doi: 10.1186/2036-7902-4-21.

  PMID: 23171481 BACKGROUND

• Heller T, Goblirsch S, Bahlas S, Ahmed M, Giordani MT, Wallrauch C, Brunetti E. Diagnostic value of FASH ultrasound and chest X-ray in HIV-co-infected patients with abdominal tuberculosis. Int J Tuberc Lung Dis. 2013 Mar;17(3):342-4. doi: 10.5588/ijtld.12.0679. Epub 2013 Jan 14.

  PMID: 23321507 BACKGROUND

• Weber SF, Saravu K, Heller T, Kadavigere R, Vishwanath S, Gehring S, Belard S, And Pocus Eti Study Group. Point-of-Care Ultrasound for Extrapulmonary Tuberculosis in India: A Prospective Cohort Study in HIV-Positive and HIV-Negative Presumptive Tuberculosis Patients. Am J Trop Med Hyg. 2018 Jan;98(1):266-273. doi: 10.4269/ajtmh.17-0486.

  PMID: 29141727 BACKGROUND

• Heller T, Mtemang'ombe EA, Huson MA, Heuvelings CC, Belard S, Janssen S, Phiri S, Grobusch MP. Ultrasound for patients in a high HIV/tuberculosis prevalence setting: a needs assessment and review of focused applications for Sub-Saharan Africa. Int J Infect Dis. 2017 Mar;56:229-236. doi: 10.1016/j.ijid.2016.11.001. Epub 2016 Nov 9.

  PMID: 27836795 BACKGROUND

• Griesel R, Cohen K, Mendelson M, Maartens G. Abdominal Ultrasound for the Diagnosis of Tuberculosis Among Human Immunodeficiency Virus-Positive Inpatients With World Health Organization Danger Signs. Open Forum Infect Dis. 2019 Apr 7;6(4):ofz094. doi: 10.1093/ofid/ofz094. eCollection 2019 Apr.

  PMID: 31011588 BACKGROUND

• Kahn D, Pool KL, Phiri L, Chibwana F, Schwab K, Longwe L, Banda BA, Gama K, Chimombo M, Chipungu C, Grotts J, Schooley A, Hoffman RM. Diagnostic Utility and Impact on Clinical Decision Making of Focused Assessment With Sonography for HIV-Associated Tuberculosis in Malawi: A Prospective Cohort Study. Glob Health Sci Pract. 2020 Mar 31;8(1):28-37. doi: 10.9745/GHSP-D-19-00251. Print 2020 Mar 30.

  PMID: 32041772 BACKGROUND

• Heuvelings CC, Belard S, Andronikou S, Jamieson-Luff N, Grobusch MP, Zar HJ. Chest ultrasound findings in children with suspected pulmonary tuberculosis. Pediatr Pulmonol. 2019 Apr;54(4):463-470. doi: 10.1002/ppul.24230. Epub 2019 Jan 11.

  PMID: 30632712 BACKGROUND

• Belard S, Heller T, Orie V, Heuvelings CC, Bateman L, Workman L, Grobusch MP, Zar HJ. Sonographic Findings of Abdominal Tuberculosis in Children With Pulmonary Tuberculosis. Pediatr Infect Dis J. 2017 Dec;36(12):1224-1226. doi: 10.1097/INF.0000000000001590.

  PMID: 28333710 BACKGROUND

• Belard S, Heller T, Grobusch MP, Zar HJ. Point-of-care ultrasound: a simple protocol to improve diagnosis of childhood tuberculosis. Pediatr Radiol. 2014 Jun;44(6):679-80. doi: 10.1007/s00247-014-2971-7. Epub 2014 May 23. No abstract available.

  PMID: 24854937 BACKGROUND

• Belard S, Heuvelings CC, Banderker E, Bateman L, Heller T, Andronikou S, Workman L, Grobusch MP, Zar HJ. Utility of Point-of-care Ultrasound in Children With Pulmonary Tuberculosis. Pediatr Infect Dis J. 2018 Jul;37(7):637-642. doi: 10.1097/INF.0000000000001872.

  PMID: 29278611 BACKGROUND

• Abrokwa SK, Ruby LC, Heuvelings CC, Belard S. Task shifting for point of care ultrasound in primary healthcare in low- and middle-income countries-a systematic review. EClinicalMedicine. 2022 Mar 6;45:101333. doi: 10.1016/j.eclinm.2022.101333. eCollection 2022 Mar.

  PMID: 35284806 BACKGROUND

• Moreto-Planas L, Sagrado MJ, Mahajan R, Gallo J, Biague E, Goncalves R, Nuozzi P, Rocaspana M, Fonseca JV, Medina C, Camara M, Nadimpalli A, Alonso B, Llosa AE, Heuvelings L, Burza S, Molina I, Ruby LC, Stratta E, Belard S. Point-of-care ultrasound for tuberculosis diagnosis in children: a Medecins Sans Frontieres cross-sectional study in Guinea-Bissau. BMJ Open. 2023 May 19;13(5):e066937. doi: 10.1136/bmjopen-2022-066937.

  PMID: 37208138 DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Laura Moretó, MD, MIH

  MSF OCBA

  PRINCIPAL INVESTIGATOR

• Sabine Belard, MD, PhD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 6, 2022
• Study Start: June 26, 2019
• Primary Completion: June 30, 2023
• Study Completion: December 15, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

GU (1); SO (1)