Active Close Contact Investigation of Tuberculosis Through Computer-aided Detection and Stool Xpert MTB/RIF Among People Living in Ethiopia

NCT05818059 | Unknown DMC

• 1 other identifier: University of Bari
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

Brief Summary

Tuberculosis is the 13th cause of death from all causes, infecting roughly the 25% of the world population, and Ethiopia is listed among the 30 high-burden countries both for TB and for HIV/TB. In recent years, the immediate consequence of the COVID-19 pandemic was a large fall in the number of newly reported TB cases indicators that represent a relevant drawback in the pursue of the 2025 End TB Milestones. For active case investigation of TB close contacts, WHO recently recommended the use of Computer- aided detection (CAD), a technology that can help chest X-ray interpretation in situations of human resources constrains, and it may be cost-effective in low-resource settings. Also, for tuberculosis diagnosis, widely-available GeneXpert on stool samples showed high diagnostic performances in term of both sensitivity and specificity. It is important to assess alternative modalities that could improve diagnosis during TB contact investigation in Ethiopia and the other countries where TB represents a crucial burden.

Conditions

Diagnosis; Tuberculosis; geneXpert

Outcome Measures

Primary Outcomes (1)

• CAD4TB and Stool GeneXpert Accurancy rate for Diagnosis of TB

  The common accuracy metrics (sensitivity, specificity, positive and negative predictive values) when assessing the accuracy of CAD4TB compared to stool Xpert MTB/RIF.

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Stool GeneXpert and Sputum GeneXpert concordance

  12 weeks

• Concordance beetwen CAD4TB and Sputum MTB/RIF

  through study completion, an average of 1 year

• TB incidence rate

  through study completion, an average of 1 year

Other Outcomes (3)

• Clinical TB diagnosis rate

  12 weeks

• Tuberculosis False positive rate

  through study completion, an average of 1 year

• Discordant diagnosis case rate

  12 weeks

Study Arms (2)

ARM 1: without computer-aided detection (CAD)

OTHER

Diagnosis of tuberculosis without the aid of CAD

Diagnostic Test: Diagnosis of Tuberculosis with computer-aided detection (CAD) software

ARM 2: with computer-aided detection (CAD)

OTHER

Diagnosis of tuberculosis with the aid of CAD

Diagnostic Test: Diagnosis of Tuberculosis with computer-aided detection (CAD) software

Interventions

Diagnosis of Tuberculosis with computer-aided detection (CAD) software DIAGNOSTIC_TEST

After enrolment, each subject will be assessed according to ARM 1 (assessment by clinician #1 without CAD) or ARM 2 (assessment by clinician #1 with CAD). Allocation to sequence ARM 1 or ARM 2 will be performed using a computer-generated random assignment list (with a 1:1 ratio), and assignments will be included in sealed opaque envelopes sequentially numbered. Clinicians cannot be masked to the assessment method (with or without CAD) and cannot be masked to the further assessment (referral for microbiological diagnosis with stool and sputum Xpert) due to care process. However, the statistician will be masked to the assessment during data analysis.

ARM 1: without computer-aided detection (CAD); ARM 2: with computer-aided detection (CAD)

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Index cases will be recruited both among hospitalized patients and patients followed in OPD clinics for completion of TB treatment.

You may not qualify if:

• Household contacts already receiving treatment for active or latent tuberculosis will be excluded from the study.

Sponsors & Collaborators

• Doctors with Africa - CUAMM: lead
• University of Bari: collaborator
• Armauer Hansen Research Institute, Ethiopia: collaborator

Study Sites (1)

St Luke Hospital

Wolisso, Oromia, Ethiopia, Ethiopia

Location

Related Publications (1)

• Segala FV, Nigussa W, Guido G, Kenate B, Facci E, Tsegaye A, Gulo B, Manenti F, Bobosha K, Cotugno S, Asmare AB, Cavallin F, Tilahun M, Miccio M, Abdissa A, Putoto G, Saracino A, Di Gennaro F. Active close contact investigation of tuberculosis through computer-aided detection and stool Xpert MTB/RIF among people living in Oromia Region, Ethiopia (CADOOL Study): protocol for a prospective, cross-sectional study. BMJ Open. 2023 Dec 21;13(12):e074968. doi: 10.1136/bmjopen-2023-074968.

  PMID: 38135314 DERIVED

MeSH Terms

Conditions

Disease; Tuberculosis

Interventions

Diagnosis, Computer-Assisted

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Diagnosis

Study Officials

• Worku Nigussa, MD

  Doctors with Africa - CUAMM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Vladimiro Segala, PhD

CONTACT

+393924804707; fvsegala@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinicians cannot be masked to the assessment method (with or without CAD) and cannot be masked to the further assessment (referral for microbiological diagnosis with stool and sputum Xpert) due to care process. However, the statistician will be masked to the assessment during data analysis.
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After enrolment, each subject will be assessed according to sequence AB (assessment by clinician #1 without CAD and assessment by clinician #2 with CAD) or sequence BA (assessment by clinician #1 with CAD and assessment by clinician #2 without CAD). Allocation to sequence AB or BA will be performed using a computer-generated random assignment list (with a 1:1 ratio), and assignments will be included in sealed opaque envelopes sequentially numbered. Clinicians cannot be masked to the assessment method (with or without CAD) and cannot be masked to the further assessment (referral for microbiological diagnosis with stool and sputum Xpert) due to care process. However, the statistician will be masked to the assessment during data analysis.

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 18, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)