Increased Tuberculosis Case Detection - DiOpTB

NCT06437184 | Recruiting

• 1 other identifier: DiOpTB - Version 17 230424
• Study Type: interventional
• Target: 1,584
• Locations: 2 countries
• Sites: 2

Brief Summary

As estimated by the WHO 10.6 million new Tuberculosis (TB) cases were identified in 2022- while more than three million went undetected and untreated. The low detection rate illustrates the failure to recognise and diagnose TB in the current cascade of healthcare and is a major obstacle to effective TB control programs. This multi-centre cluster-randomised clinical trial will evaluate the effect (i.e., diagnostic yield) of improving the point-of-care diagnostics already in place in most primary health-care centres in low-resource settings. The present study will be conducted in two different geographical settings in the Western and Eastern African countries of Guinea Bissau and Ethiopia. This improved clinical diagnostic pathway may improve case detection rates at primary healthcare level, ensuring prompt commencement of treatment, thereby diminishing transmission risk in the community and improving treatment outcomes. The Optimized Diagnostic Procedure (ODP) will utilize instructed sputum sampling and pooling as well as computer-aided detection (CAD) chest X-ray (CXR) and additional pooled sputum sample as well as non-sputum sampling (faecal and a buccal/tongue swab and saliva) for GeneXpert Ultra PCR (Xpert) as state-of-the-art add-ons to the routine diagnostic pathway for TB. This adds to the key components of the WHO "End TB" strategy - early diagnosis - and if successful, may be rapidly approved by the WHO and implemented by governments globally with potentially major public health benefits. The study will be conducted in close liaison with the national Ministries of Health and TB programs in Guinea-Bissau and Ethiopia. This will facilitate any relevant findings to be taken forward for implementation into policy and practice. Capacity development, training and educational activities will be closely aligned to this study.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• 1. Number of smear positive, Xpert PCR positive, or CXR positive patients comparing EUDP to ODP.

  1\. Number of smear positive, Xpert PCR positive, or CXR positive patients comparing EUDP to ODP.

  1.5 years

Secondary Outcomes (4)

• 1. Number of patients on active TB treatment comparing EUDP clinics to ODP clinics.

  1.5 years

• 2. Diagnostic yield of CAD CXR compared to smear microscopy, Xpert PCR, and culture.

  1.5 years

• 3. Follow-up rates in the cascade of care (i.e. one-week and six-months follow-up for all included and treatment start and outcome for all diagnosed with TB)

  1.5 years

• 4. Differences in diagnostic yield between instructed sampling, buccal samples, fecal samples and routine sputum sample.

  1.5 years

Study Arms (2)

Enhanced Usual Diagnostic Procedure (EUDP)

NO INTERVENTION

The standard TB diagnostics in both settings consist of performing the sputum smear analysis by the clinical routine. Smear-negative cases will be followed as per standard routine (Figure 1A).

The Optimized Diagnostic Procedure (ODP) intervention

ACTIVE COMPARATOR

1. Oral and mobile phone-guided instructions by study staff 2. Pooling of two spot sputum samples (9) 3. Smear-negative cases at the first visit will be assessed for persisting symptoms and referred to a CXR unit.

Diagnostic Test: ODP

Interventions

ODP DIAGNOSTIC_TEST

se previously

The Optimized Diagnostic Procedure (ODP) intervention

Eligibility Criteria

• Age: 15 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥15 years old
• presumed TB with cough, sputum production, and/or weight loss of any duration

You may not qualify if:

• TB treatment within the past year.
• Cerebral disturbances impairing the ability to give informed consent or follow the treatment regime.

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Linkoeping University: collaborator
• University of Gondar: collaborator

Study Sites (2)

Gondar University

Gonder, Ethiopia

RECRUITING

Projecto Saude de Bandim

Bissau, Guinea-Bissau

RECRUITING

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Frauke Rudolf

CONTACT

51372359; frauke.rudolf@au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associated Professor

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: May 31, 2024
• Study Start: June 3, 2024
• Primary Completion: October 30, 2025
• Study Completion: March 31, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

ET (1); GU (1)