Using Isoniazid to Prevent Tuberculosis in Lupus Patients
Study on the Safety of Administering Isoniazid to Systemic Lupus Erythematosus Patients to Prevent Tuberculosis
This study is testing if the medication Isoniazid can help prevent tuberculosis in people with lupus who are at higher risk for the disease.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Universitas Padjadjaran Academic / other |
| Locations | 1 site (Bandung, West Java) |
| Trial ID | NCT06618573 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of administering Isoniazid, a medication used to prevent tuberculosis (TB), to patients with Systemic Lupus Erythematosus (SLE). Given that SLE patients are at a higher risk for TB due to their immunocompromised state, the study aims to evaluate whether Isoniazid can effectively reduce the incidence of TB in this vulnerable population. The trial will include SLE patients who are in remission or have low to moderate disease activity and will monitor for any adverse effects associated with the treatment. The study is being conducted at Rumah Sakit Dr Hasan Sadikin in Bandung, West Java.
Who should consider this trial
Good fit: Ideal candidates for this study are SLE patients who are not currently experiencing active TB, are not undergoing TB treatment, and have low to moderate disease activity.
Not a fit: Patients with a history of TB, chronic liver disease, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of tuberculosis infections in patients with lupus, improving their overall health outcomes.
How similar studies have performed: Previous studies have shown that Isoniazid prophylaxis can be effective in preventing TB in immunocompromised populations, suggesting potential success for this approach in SLE patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: SLE patients with conditions of : * No signs and symptoms of active TB * Not under TB treatment * No History of TB, malignancy, HIV, liver function test abnormality * Not in pregnancy/lactation * No other active infections * Remission or low to moderate disease activity state * Consented to join the study completely Exclusion Criteria: SLE patients with conditions of : * History of allergy to Isoniazid * Chronic liver disease, including chronic hepatitis B or C virus * Malignancy * Pregnancy
Where this trial is running
Bandung, West Java
- Rumah Sakit Dr Hasan Sadikin, Universitas Padjadjaran — Bandung, West Java, Indonesia (Recruiting)
Study contacts
- Principal investigator: Laniyati Hamijoyo, MD, PhD — Universitas Padjadjaran
- Study coordinator: Laniyati Hamijoyo, MD, PhD
- Email: laniyati.hamijoyo@unpad.ac.id
- Phone: +62222040151
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.