Alternative Diagnoses in Patients About to Start Empiric Tuberculosis Treatment

NCT06737029 | Active Not Recruiting

• 2 other identifiers: ALTTB5075-2024
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to determine whether in patients who are diagnosed with tuberculosis on a clinical basis (where tuberculosis is not found in the sputum) might have other lung diseases than tuberculosis. Depending on the precise nature of your complaints, additional investigations shall be requested by the study investigators. Possible additional investigations will include laboratory tests on samples of your blood, an additional chest X-ray, lung function testing (where you will have to blow air into a machine, so that your lung capacity is registered), CT-scan, and bronchoscopy. The information obtained through the investigations done in this study will help in the management of your illness and other patients who are diagnosed with tuberculosis on a clinical basis.

Conditions

Tuberculosis; Lung Diseases

Keywords

tubcerculosis; empiric treatment; alternative diagnosis; lung disease

Outcome Measures

Primary Outcomes (1)

• Diagnosis at 6 months

  Most likely diagnosis for the patient's complaints, tuberculosis versus alternative diagnosis

  6 months

Secondary Outcomes (3)

• Survival

  6 months

• Quality of Life

  6 months

• TB treatment received

  6 months

Other Outcomes (1)

• Side effects attributed to TB treatment

  6 months

Study Arms (1)

Primary cohort

All patients included in the study, who are about to start empiric tuberculosis treatment

Diagnostic Test: Enhanced diagnostic workup

Interventions

Enhanced diagnostic workup DIAGNOSTIC_TEST

Patients will undergo review by a study physician, including a detailed history and physical examination, as well as review of additional investigations that have been performed thus far. Based on the precise nature of the complaints, and additional findings, additional diagnostic testing may be requested, including, but not limited to: blood testing, spirometry, computed tomography of the chest, repeat chest X-ray, sputum investigations, or bronchoscopy.

Primary cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients who have a negative initial GeneXpert MTB/RIF test on sputum, but are about to start standard first-line treatment for suspected pulmonary tuberculosis on clinical grounds (i.e. empiric tuberculosis treatment), at four first-level Hospitals in Lusaka, Zambia. Patients will be excluded if they are inpatients (due to suspected tuberculosis), or are unable to visit the central study site for additional review or investigations.

You may qualify if:

• adult patient
• about to start TB treatment for suspected pulmonary tuberculosis, but with sputum GeneXpert negative

You may not qualify if:

• suspected drug-resistant tuberculosis
• inpatient (because of suspected tuberculosis)
• unable to visit central study site for review or additional investigations

Sponsors & Collaborators

• Stichting Longartsen voor Afrika: lead
• Mr. Willem Bakhuys Roozeboomstichting: collaborator

Study Sites (1)

University Teaching Hospital

Lusaka, Zambia

Location

MeSH Terms

Conditions

Tuberculosis; Lung Diseases

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 17, 2024
• Study Start: December 1, 2024
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After completion of the study and first publication
• Access Criteria: Upon reasonable request, as determined by the authors

Locations

ZA (1)