Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04600167
Status:
RECRUITING
Last Update Posted:
2023-03-29
First Post:
2020-09-15
Brief Title:
Preventive Treatment Of Latent Tuberculosis Infection In People With Diabetes Mellitus
Sponsor:
Dr Nyanda Elias Ntinginya
Organization:
National Institute for Medical Research Tanzania
Study Overview
Official Title:
A Randomized Double Blind Placebo Controlled Trial of Rifapentine and Isoniazid for Prevention of Tuberculosis in People With Diabetes
Status:
RECRUITING
Status Verified Date:
2023-03
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:
PROTID
Brief Summary:
Diabetes mellitus DM increases susceptibility to Tuberculosis TB and worsens TB patient outcomes The number of patients with combined TB and DM now outnumbers that of combined TB and HIV and it has been estimated that 15-30 of TB disease may be attributable to diabetes globally This may be expected to rise substantially as DM prevalence increases Treatment of Latent TB Infection LTBI in this population will likely have a significant clinical benefit Similar to HIV-infected individuals those with DM might benefit from therapy to prevent the development of TB disease Current international guidelines do not recommend LTBI management in people with DM but this is because no studies have examined the risk-benefit ratio of such an intervention To date no RCTs have been conducted to investigate the efficacy and safety of preventive treatment of LTBI in DM patients Based on evidence on effectiveness safety and treatment completion rates 3HP has been selected as the regimen of choice for this study of African people living with DM People living with DM will be randomized to 3HP or placebo to determine the efficacy of 3HP in the prevention of TB disease in this population PROTIDs preventive treatment of LTBI among people with DM will generate the first solid evidence to support or refute the use of preventive treatment against TB in people with DM
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None