Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 55Years
FEMALE
NCT06618573

Safety of Administering Isoniazid to SLE Patients to Prevent TB

Led by Universitas Padjadjaran · Updated on 2024-10-01

60

Participants Needed

1

Research Sites

172 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Systemic Lupus Erythematosus (SLE) is a prototypical systemic autoimmune disease characterized by heterogeneity, multisystem involvement, and production of multiple autoantibodies. Clinical features can vary, from mild skin and joint involvement to severe and life-threatening conditions. Patients with lupus are more susceptible to infections, in addition to being immunocompromised, and due to the administration of corticosteroid and cytotoxic drugs. The presence of these infections is a cause of death in lupus disease in addition to the activity of the disease itself, especially in Asia-Pacific countries. One infection that often occurs in lupus is Tuberculosis (TB). Efforts have been made to prevent TB infection in vulnerable populations, including isoniazid (INH) prophylaxis. In 2010, World Heatlh Organization issued guidelines for HIV patients to receive INH prophylaxis to prevent TB infection. The implementation of Isoniazid Preventive Therapy (IPT) is quite cheap using INH with mild side effects.18 A meta-analysis study of INH prophylaxis in patients with HIV found that the efficacy of this prophylaxis significantly reduced TB incidence by 35% with an RR of 0.65%. In addition, INH was found to be safe, with no significant increase in drug reactions, according to a meta-analysis of prophylaxis studies in HIV patients. However, there is no guideline for INH prophylaxis for SLE patients, as there is for HIV patients, due to lack of data on this issue. Studies on the effectiveness of INH prophylaxis on the prevention of TB infection for SLE patients should be conducted, but before that, studies on the safety of INH therapy in SLE patients should be conducted.

CONDITIONS

Official Title

Safety of Administering Isoniazid to SLE Patients to Prevent TB

Who Can Participate

Age: 18Years - 55Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 to 55 years
  • Diagnosed with Systemic Lupus Erythematosus (SLE)
  • No signs or symptoms of active Tuberculosis (TB)
  • Not currently under TB treatment
  • No history of TB, malignancy, or HIV infection
  • Normal liver function tests
  • Not pregnant or breastfeeding
  • No other active infections
  • In remission or have low to moderate SLE disease activity
  • Provided informed consent to participate
Not Eligible

You will not qualify if you...

  • History of allergy to isoniazid
  • Chronic liver disease, including chronic hepatitis B or C
  • Malignancy
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Rumah Sakit Dr Hasan Sadikin, Universitas Padjadjaran

Bandung, West Java, Indonesia, 40161

Actively Recruiting

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Research Team

L

Laniyati Hamijoyo, MD, PhD

CONTACT

E

Edhyana Sahiratmadja, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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