Latent Tuberculosis Clinical Trial
Official title:
Efficacy of Risk-Targeted Video Based Directly on Observed Therapy for Latent TB
NCT number | NCT03783728 |
Other study ID # | 29312 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | June 30, 2019 |
Est. completion date | January 31, 2020 |
Verified date | June 2019 |
Source | St. Louis University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Center for Disease Control (CDC) data reveal that after years of sustained decrease, the incidence of active tuberculosis (TB) disease in the US has plateaued. Most of the cases occur when Mycobacterium tuberculosis (Mtb) reactivates replication in people who have latent tuberculosis infection (LTBI). Only 5 to 10% of subjects with LTBI develop active TB Infection over their lifetime. Current US guidelines recommend treating everyone with LTBI to stop progression to active TB. As treatment is long, only about 45-55% of patients finish treatment overall, regardless of whether the patients are at high (>10%) or low lifetime risk of reactivation. The investigator's study aims to test the efficacy of a combined approach of first determining subjects at high risk of reactivation and then treating them with a CDC approved once a week treatment regimen, directly observed by a nurse over video (video-based Directly Observed Therapy, vDOT). Ensuring treatment of the high-risk group will eventually decrease the community active TB burden.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 31, 2020 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Age 18 years + 1 day (defined as date of birth plus one day). This age cutoff has been selected as tstin3d.com has only been validated for this age group. Subjects must have all of the following: - Untreated Latent Tuberculosis Infection (LTBI), defined as positive Tuberculin skin test/QuantiFERON TB Gold test or T-spot assay done within 1 month prior to enrollment. - Absence of active TB disease as determined by history, physical examination, chest X-ray, (sputum smear and/or culture done as needed by the assessing physician for Mtb). - Greater than 10% cumulative risk of developing active TB disease (determined by TSTin3D.com). Exclusion Criteria: - A subject will be excluded if any of the following criteria are met: - Presence of active TB disease - BMI <16 - Cardiovascular instability (Blood pressure: Systolic >180 or <90 mm/Hg or Diastolic >100 or < 50mm/Hg; pulse <40 or >110) - Chest X-Ray report within last 3 months not available - HIV positive and currently on treatment with a regimen that has severe drug interactions with 3HP. - Presumed infected with INH or Rifapentine (RIF)-resistant M. tuberculosis - Women who are pregnant, nursing or expect to become pregnant for the duration of the study. - Temperature =38.5°C or other clinical evidence of an acute infection at screening - History of treatment for >14 consecutive days with a rifamycin or >30 consecutive days with isoniazid during the previous 2 years - Documented history of completing adequate treatment for active tuberculosis or latent M. tuberculosis infection in a HIV-seronegative person - History of sensitivity/intolerance to isoniazid or rifamycins - Serum aspartate aminotransferase (AST) >5 times the upper limit of normal (ULN) if AST was determined - Hemodynamic instability or medical/psychological condition precluding participation in the study as judged by the investigator - No access to a smartphone for personal use - Refuse blood draws - Refuse to participate in the study - If female of childbearing potential and on a hormonal contraception method, refuse to use an additional barrier method with the hormonal method for the duration of the study |
Country | Name | City | State |
---|---|---|---|
United States | Saint Louis University | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
St. Louis University |
United States,
Bliven-Sizemore EE, Sterling TR, Shang N, Benator D, Schwartzman K, Reves R, Drobeniuc J, Bock N, Villarino ME; TB Trials Consortium. Three months of weekly rifapentine plus isoniazid is less hepatotoxic than nine months of daily isoniazid for LTBI. Int J — View Citation
Holzschuh EL, Province S, Johnson K, Walls C, Shemwell C, Martin G, Showalter A, Dunlay J, Conyers A, Griffin P, Tausz N. Use of Video Directly Observed Therapy for Treatment of Latent Tuberculosis Infection - Johnson County, Kansas, 2015. MMWR Morb Morta — View Citation
Li J, Munsiff SS, Tarantino T, Dorsinville M. Adherence to treatment of latent tuberculosis infection in a clinical population in New York City. Int J Infect Dis. 2010 Apr;14(4):e292-7. doi: 10.1016/j.ijid.2009.05.007. Epub 2009 Aug 4. — View Citation
Menzies D, Gardiner G, Farhat M, Greenaway C, Pai M. Thinking in three dimensions: a web-based algorithm to aid the interpretation of tuberculin skin test results. Int J Tuberc Lung Dis. 2008 May;12(5):498-505. — View Citation
Salinas JL, Mindra G, Haddad MB, Pratt R, Price SF, Langer AJ. Leveling of Tuberculosis Incidence - United States, 2013-2015. MMWR Morb Mortal Wkly Rep. 2016 Mar 25;65(11):273-8. doi: 10.15585/mmwr.mm6511a2. — View Citation
Sterling TR, Moro RN, Borisov AS, Phillips E, Shepherd G, Adkinson NF, Weis S, Ho C, Villarino ME; Tuberculosis Trials Consortium. Flu-like and Other Systemic Drug Reactions Among Persons Receiving Weekly Rifapentine Plus Isoniazid or Daily Isoniazid for — View Citation
Sterling TR, Scott NA, Miro JM, Calvet G, La Rosa A, Infante R, Chen MP, Benator DA, Gordin F, Benson CA, Chaisson RE, Villarino ME; Tuberculosis Trials Consortium, the AIDS Clinical Trials Group for the PREVENT TB Trial (TBTC Study 26ACTG 5259) The inves — View Citation
Sterling TR, Villarino ME, Borisov AS, Shang N, Gordin F, Bliven-Sizemore E, Hackman J, Hamilton CD, Menzies D, Kerrigan A, Weis SE, Weiner M, Wing D, Conde MB, Bozeman L, Horsburgh CR Jr, Chaisson RE; TB Trials Consortium PREVENT TB Study Team. Three mon — View Citation
Stuurman AL, Vonk Noordegraaf-Schouten M, van Kessel F, Oordt-Speets AM, Sandgren A, van der Werf MJ. Interventions for improving adherence to treatment for latent tuberculosis infection: a systematic review. BMC Infect Dis. 2016 Jun 8;16:257. doi: 10.118 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients completing treatment | Achieving > 90% treatment completion in patients with LTBI at > 10% cumulative individual risk of developing active TB using vDOT. | 4 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05073926 -
Rifampicin Resistance in S. Aureus During and After Treatment for Latent Tuberculosis
|
||
Not yet recruiting |
NCT04428294 -
Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation
|
Phase 4 | |
Completed |
NCT02276755 -
Vitamin D Supplementation in TB Prevention
|
Phase 3 | |
Withdrawn |
NCT03498534 -
Evaluation of Diabetes Control and Effect on Transmission and Development of Tuberculosis
|
Phase 4 | |
Active, not recruiting |
NCT03988933 -
2R2: Higher Dose Rifampin for 2 Months vs Standard Dose Rifampin for Latent TB.
|
Phase 2 | |
Recruiting |
NCT06022146 -
TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts
|
Phase 3 | |
Active, not recruiting |
NCT04188041 -
Improving Rhode Island's Tuberculosis Preventive Services in Primary Care
|
N/A | |
Recruiting |
NCT03730181 -
Tuberculosis Clinical Trials Consortium Study 35
|
Phase 1/Phase 2 | |
Completed |
NCT01967134 -
Safety and Immunogenicity Study of AERAS-456 Vaccine for Tuberculosis
|
Phase 1 | |
Completed |
NCT00257907 -
Immune Response to Mycobacterium Tuberculosis Infection
|
||
Recruiting |
NCT05756582 -
Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students
|
||
Active, not recruiting |
NCT04557176 -
TB Screening Improves Preventive Therapy Uptake
|
N/A | |
Completed |
NCT02119130 -
Quantiferon Gold Test for Detecting Tuberculosis (TB) Infection in HIV/AIDS Patients in South Africa
|
N/A | |
Not yet recruiting |
NCT06281834 -
Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
|
Phase 1 | |
Not yet recruiting |
NCT02512484 -
Improving the Detection of Active Tuberculosis in Accident and Emergency Departments
|
N/A | |
Completed |
NCT00763295 -
Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV?
|
N/A | |
Completed |
NCT01850043 -
The Epidemiology of TST Change in Korea
|
N/A | |
Completed |
NCT02090374 -
Development of Human Nasal Challenge Models With Microbial Constituents and Grass Pollen
|
N/A | |
Completed |
NCT02073669 -
Latent Tuberculosis in Second Generation Immigrants From High Risk Countries Compare to Low-risk Young Israeli Adults
|
N/A | |
Completed |
NCT02880982 -
Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren
|
Phase 3 |