Comparative Efficacy of CUS, CXR and CAD in TB Diagnosis in LMIC

NCT06409780 | Not Yet Recruiting DMC

• 1 other identifier: CUSTBv1
• Study Type: interventional
• Target: 136
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pulmonary Tuberculosis (TB) remains a significant global health concern, particularly in low- and middle-income countries (LMIC), where resources for healthcare are often limited. While CXR is the standard imaging modality for TB diagnosis, its sensitivity and specificity can vary depending on factors such as the stage of the disease and the quality of the image obtained. This study endeavors to assess the diagnostic precision of Chest Ultrasound (CUS) relative to Chest X-ray (CXR) and CAD score in the detection of Pulmonary Tuberculosis (TB) among both index cases and household contacts.

Conditions

Tuberculosis, Pulmonary

Keywords

Tuberculosis; Chest Ultrasound; Chest X-Ray; CAD; LMIC

Outcome Measures

Primary Outcomes (2)

• Specificity of CUS in TB diagnosis

  Specificity of CUS in diagnosing TB compared to CXR and CAD score among index cases and household contacts

  1 year

• Sensitivity of CUS in TB diagnosis

  Sensitivity of CUS in diagnosing TB compared to CXR and CAD score among index cases and household contacts

  1 year

Secondary Outcomes (3)

• Positive predictive value of CUS in TB diagnosis

  1 year

• Negative predictive value of CUS in TB diagnosis

  1 year

• Concordance of CUS, CXR and CAD in TB

  1 year

Study Arms (2)

Diagnosis of Pulmonary Tuberculosis in index case

EXPERIMENTAL

CUS, CXR and CAD analysis will be performed in all patients with new diagnosis of pulmonary tuberculosis according to microbiological criteria

Diagnostic Test: Comparative analysis of CUS, CAD and CXR in pulmonary TB

Screening of Pulmonary Tuberculosis in household contacts

EXPERIMENTAL

CUS, CXR and CAD analysis will be performed in all participants who are household contacts of an index case

Diagnostic Test: Comparative analysis of CUS, CAD and CXR in pulmonary TB

Interventions

Comparative analysis of CUS, CAD and CXR in pulmonary TB DIAGNOSTIC_TEST

The strumental analysis of pulmonary TB signs with chest ultrasound, chest x-ray and CAD will be compared in two different settings: index cases and household contacts

Diagnosis of Pulmonary Tuberculosis in index case; Screening of Pulmonary Tuberculosis in household contacts

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects older than 5 years old.
• Capacity to provide informed consensus.
• Condition requiring a diagnosis of pulmonary tuberculosis within 7 days, with either microbiologically or radiologically criteria (index case), or being the household contact reported by an index case.

You may not qualify if:

• Exposure to any antitubercular treatment prior 7 days than the enrollment after the initiation of clinic
• Withdraw of the informed consent

Sponsors & Collaborators

• University of Bari: lead
• Doctors with Africa - CUAMM: collaborator

Related Publications (12)

• Arega B, Tilahun K, Minda A, Agunie A, Mengistu G. Prevalence rate of undiagnosed tuberculosis in the community in Ethiopia from 2001 to 2014: systematic review and meta-analysis. Arch Public Health. 2019 Jul 11;77:33. doi: 10.1186/s13690-019-0360-2. eCollection 2019.

  PMID: 31333842 BACKGROUND

• Danchuk SN, Solomon OE, Kohl TA, Dreyer V, Barilar I, Utpatel C, Niemann S, Soolingen DV, Anthony R, van Ingen J, Michael JS, Behr MA. Challenging the gold standard: the limitations of molecular assays for detection of Mycobacterium tuberculosis heteroresistance. Thorax. 2024 Jun 14;79(7):670-675. doi: 10.1136/thorax-2023-220202.

  PMID: 38286614 BACKGROUND

• Acharya V, Dhiman G, Prakasha K, Bahadur P, Choraria A, M S, J S, Prabhu S, Chadaga K, Viriyasitavat W, Kautish S. AI-Assisted Tuberculosis Detection and Classification from Chest X-Rays Using a Deep Learning Normalization-Free Network Model. Comput Intell Neurosci. 2022 Oct 3;2022:2399428. doi: 10.1155/2022/2399428. eCollection 2022.

  PMID: 36225551 BACKGROUND

• Abraham Y, Manyazewal T, Amdemariam Z, Petros H, Ayenadis F, Mekonen H, Workneh F. Facilitators and barriers to implementing chest radiography in tuberculosis systematic screening of clinically high-risk groups in Ethiopia: A qualitative study. SAGE Open Med. 2024 Feb 19;12:20503121241233232. doi: 10.1177/20503121241233232. eCollection 2024.

  PMID: 38379811 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

• Suttels V, Du Toit JD, Fiogbe AA, Wachinou AP, Guendehou B, Alovokpinhou F, Toukoui P, Hada AR, Sefou F, Vinasse P, Makpemikpa G, Capo-Chichi D, Garcia E, Brahier T, Keitel K, Ouattara K, Cissoko Y, Beye SA, Mans PA, Agodokpessi G, Boillat-Blanco N, Hartley MA. Point-of-care ultrasound for tuberculosis management in Sub-Saharan Africa-a balanced SWOT analysis. Int J Infect Dis. 2022 Oct;123:46-51. doi: 10.1016/j.ijid.2022.07.009. Epub 2022 Jul 8.

  PMID: 35811083 BACKGROUND

• Abuzerr S, Zinszer K. Computer-aided diagnostic accuracy of pulmonary tuberculosis on chest radiography among lower respiratory tract symptoms patients. Front Public Health. 2023 Oct 27;11:1254658. doi: 10.3389/fpubh.2023.1254658. eCollection 2023.

  PMID: 37965525 BACKGROUND

• Fentress M, Ugarte-Gil C, Cervantes M, Rivas D, Moore D, Caliguiri P, Bergman K, Noazin S, Padovani A, Gilman RH. Lung Ultrasound Findings Compared with Chest X-Ray Findings in Known Pulmonary Tuberculosis Patients: A Cross-Sectional Study in Lima, Peru. Am J Trop Med Hyg. 2020 Nov;103(5):1827-1833. doi: 10.4269/ajtmh.20-0542.

  PMID: 32815504 BACKGROUND

• Fentress M, Henwood PC, Maharaj P, Mitha M, Khan D, Caligiuri P, Karat AS, Olivier S, Edwards A, Ramjit D, Ngcobo N, Wong EB, Grant AD. High sensitivity of ultrasound for the diagnosis of tuberculosis in adults in South Africa: A proof-of-concept study. PLOS Glob Public Health. 2022 Oct 6;2(10):e0000800. doi: 10.1371/journal.pgph.0000800. eCollection 2022.

  PMID: 36962607 BACKGROUND

• Cozzi D, Bartolucci M, Giannelli F, Cavigli E, Campolmi I, Rinaldi F, Miele V. Parenchymal Cavitations in Pulmonary Tuberculosis: Comparison between Lung Ultrasound, Chest X-ray and Computed Tomography. Diagnostics (Basel). 2024 Feb 29;14(5):522. doi: 10.3390/diagnostics14050522.

  PMID: 38472994 BACKGROUND

• Rea G, Sperandeo M, Lieto R, Bocchino M, Quarato CMI, Feragalli B, Valente T, Scioscia G, Giuffreda E, Foschino Barbaro MP, Lacedonia D. Chest Imaging in the Diagnosis and Management of Pulmonary Tuberculosis: The Complementary Role of Thoraci Ultrasound. Front Med (Lausanne). 2021 Dec 10;8:753821. doi: 10.3389/fmed.2021.753821. eCollection 2021.

  PMID: 34957142 BACKGROUND

• Guido G, Nigussa W, Cotugno S, Kenate Sori B, Bobbio FA, Gulo B, Pisani L, Manenti F, Miressa M, Cavallin F, Abata S, Segala FV, Reta A, Tulome O, Putoto G, Iatta R, Tuttolomondo A, Veronese N, Barbagallo M, Saracino A, Di Gennaro F. Comparative effectiveness of chest ultrasound, chest X-ray and computer-aided diagnostic (CAD) for tuberculosis diagnosis in low-resource setting: study protocol for a cross-sectional study from Ethiopia. Front Public Health. 2024 Nov 28;12:1476866. doi: 10.3389/fpubh.2024.1476866. eCollection 2024.

  PMID: 39691654 DERIVED

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Tuberculosis

Interventions

Diagnosis, Computer-Assisted

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnosis

Central Study Contacts

Giacomo Guido, MD

CONTACT

3202842602; giacguido@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 10, 2024
• Study Start: May 5, 2024
• Primary Completion: May 5, 2024
• Study Completion: April 30, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR