Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317330
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2006-04-20
Brief Title:
A Randomized Trial of DOTS Versus Enhanced DOTS for Community Control of Tuberculosis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Trial of DOTS Versus Enhanced DOTS for Community Control of Tuberculosis
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
This will be a single site prospective community-randomized trial to study the effectiveness for two TB prevention strategies on the community incidence of TB DOTS versus Enhanced DOTS DOTS-Ampliado or DOTS-A DOTS-A will add intensive screening of household contacts of active TB cases and the provision of TB treatment or prophylaxis as needed to the standard DOTS regimen Adult contacts in the DOTS-A communities will be offered enrollment into a randomized clinical trial comparing rifapentineisoniazid preventive therapy to rifampinpyrazinamide Subjects will be recruited from TB cases identified for treatment at the Health Clinics of eight urban communities These communities will be matched and randomly assigned to receive either DOTS or DOTS-A strategy The change in the incidence of TB in the two groups of communities will be measured after a 4-year period to determine whether DOTS-A strategy significantly reduces the incidence of TB compared to DOTS alone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ICIDR1 | None | None | None |