Comparing Two Preventive Regimens for Latent Tuberculosis Infection (LTBI)

NCT01398618 | Unknown Phase 3 DMC

• 1 other identifier: 201010017M
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

Though still an endemic area, the incidence of tuberculosis (TB) in Taiwan is decreasing in recent years. Further reduction in TB incidence, or even elimination should rely on treatment for LTBI. However, which is the cost-effective screening method or what is the cost-effective regimen in Taiwan is still unclear. Therefore, the investigators designed this prospective study to follow up adult household contacts with LTBI for 2 years and compare the efficacy of 9-month isoniazid and 4-month rifampicin).

Conditions

Latent Tuberculosis Infection

Keywords

latent tuberculosis infection; tuberculosis; interferon-gamma release assay; preventive therapy; 9-month isoniazid; 4-month rifampin

Outcome Measures

Primary Outcomes (1)

• Number of Participants developing active tuberculosis

  every 6 months for 2 years

Secondary Outcomes (1)

• the sensitivity and specificity of tuberculin-skin-testing and QuantiFERON TB-Gold assay for the development of active pulmonary tuberculosis

  Every 6 months for 2 years

Study Arms (2)

4M-RMP

EXPERIMENTAL

adult household contacts with latent tuberculosis infection receiving 4-month rifampicin preventive therapy

Drug: 4-month rifampin vs. 9-month isoniazid

9M-INH

ACTIVE COMPARATOR

adult household contact with latent tuberculosis infection receiving 9-month isoniazid preventive therapy

Drug: 4-month rifampin vs. 9-month isoniazid

Interventions

4-month rifampin vs. 9-month isoniazid DRUG

In the 4M-RMP group, enrolled subjects received 600 mg rifampin daily for 4 months. In the 9M-INH group, enrolled subjects received 300 mg isoniazid daily for 9 months.

Also known as: 4-month RMP vs. 9-month INH

4M-RMP; 9M-INH

Eligibility Criteria

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

You may qualify if:

• household contact of patients with newly diagnosed, culture-confirmed pulmonary tuberculosis
• age \> 18
• tuberculin skin testing-positive or QuantiFERON-positive
• hemoglobin \> 8 g/dL
• neutrophil \> 750 /uL
• total bilirubin \< 2.5 mg/dL
• aspartic and alanine transaminases \< 2 times of upper limit of normal
• willing to receive serology tests for HBV and HCV infection
• no history of allergy to isoniazid and rifampin
• not currently pregnant or breast-feeding

You may not qualify if:

• the M. tuberculosis isolate of the index case were isoniazid- or rifampin-resistant
• liver cirrhosis
• clinical or radiographical evidence of active tuberculosis
• active hepatitis
• currently receiving medication that have documented drug interaction with isoniazid or rifampin
• life expectancy \< 3 years

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

Chest Hospital, Department of Health, Executive Yuan

Tainan, 71742, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Links

• Website of Research Ethic Committee of National Taiwan University Hospital

MeSH Terms

Conditions

Latent Tuberculosis; Tuberculosis

Interventions

Isoniazid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jann-Yuan Wang, Ph.D.

  Attending Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 20, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 20, 2011

Record last verified: 2011-06

Locations

TW (2)