A Randomized Trial of DOTS Versus Enhanced DOTS for Community Control of Tuberculosis

NCT00317330 | Completed Phase 3

• 2 other identifiers: 01-581ICIDR#1
• Study Type: interventional
• Target: 6,400
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the effectiveness of two different tuberculosis (TB) prevention strategies, DOTS or DOTS-A. DOTS is the current prevention strategy for TB. DOTS-A is an enhanced prevention strategy that will screen household members of individuals diagnosed with active TB and will provide enhanced treatment as needed. The study will be conducted in 8 communities located in Rio de Janeiro. Study participants will include 6400 males and females of all ages, including active TB patients and their household contacts. Patients with TB identified for treatment at the Health Clinics of 8 urban communities will be eligible. The communities will be assigned to 1 of the 2 prevention strategies, DOTS or DOTS-A. After 4 years, the information gathered during the study will be used to determine the incidence of TB in these communities to see which prevention strategy was more effective in decreasing TB.

Conditions

Tuberculosis

Interventions

Isoniazid DRUG

Pyrazinamide DRUG

Rifampin DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Cases will include:
• Any age male or female with new or recurrent diagnosis of TB
• Willingness and ability to adhere to study medications and protocol procedures.
• Willingness to provide signed informed consent or signed informed consent/assent provided by parent or legal guardian.
• Contacts will include:
• Male or female living in household of a pulmonary TB case, at high risk for developing TB (but without evidence for active TB).
• High-risk household contacts will be defined as those who are:
• HIV seropositive, regardless of the results of initial tuberculin skin test (TST)
• TST positive at the time of the first household evaluation. TST positivity will be defined as greater than or equal to 5 mm induration of 5 TU of PPD using the Mantoux method, read between 48 and 72 hours after application.
• TST negative at the time for the first household evaluation and TST positive at the time of the second household evaluation 3 months later.
• Willingness to provide signed informed consent or signed informed consent/assent provided by parent or legal guardian.

You may not qualify if:

• Contacts will be excluded from preventive therapy if:
• Current active clinical tuberculosis-confirmed or suspected
• History of sensitivity/intolerance to any of the study medications
• Evidence of acute hepatitis
• History or laboratory evidence of cirrhosis
• Pregnant females (treatment of latent infection will be deferred)

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Municipal Health Department

Rio de Janeiro, 21945, Brazil

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Isoniazid; Pyrazinamide; Rifampin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Pyrazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: April 20, 2006
• First Posted: April 24, 2006
• Study Start: December 1, 2004
• Study Completion: June 1, 2005
• Last Updated: August 27, 2010

Record last verified: 2006-08

Locations

BR (1)