Investigating alternative lung diseases in patients diagnosed with tuberculosis
Enhanced Diagnostic Workup for Patients About to Start Empiric Tuberculosis Treatment in Lusaka, Zambia
This study is trying to see if people who are diagnosed with tuberculosis but test negative actually have other lung diseases by doing a variety of tests on them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stichting Longartsen voor Afrika Academic / other |
| Locations | 1 site (Lusaka) |
| Trial ID | NCT06737029 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore whether patients clinically diagnosed with tuberculosis, but who test negative for the disease in sputum samples, may actually have other lung diseases. Participants will undergo a series of additional diagnostic tests, including blood tests, chest X-rays, lung function tests, CT scans, and bronchoscopy, to gather comprehensive information about their lung health. The findings from these investigations are intended to improve the management of tuberculosis and similar lung conditions in affected patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults who are about to start tuberculosis treatment based on clinical suspicion but have negative sputum GeneXpert results.
Not a fit: Patients suspected of having drug-resistant tuberculosis or those who are hospitalized due to suspected tuberculosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and better treatment options for patients with lung diseases that mimic tuberculosis.
How similar studies have performed: While the approach of enhancing diagnostic workup in tuberculosis cases is not widely tested, the study builds on existing knowledge of diagnostic challenges in tuberculosis management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult patient * about to start TB treatment for suspected pulmonary tuberculosis, but with sputum GeneXpert negative Exclusion Criteria: * suspected drug-resistant tuberculosis * inpatient (because of suspected tuberculosis) * unable to visit central study site for review or additional investigations
Where this trial is running
Lusaka
- University Teaching Hospital — Lusaka, Zambia (Recruiting)
Study contacts
- Study coordinator: Thijs Hoffman, MD, PhD
- Email: thijs_odijk@hotmail.com
- Phone: 260768718829
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.