Tuberculosis Clinical Trial
Official title:
Acceptability and Completion Rates of a New 12 Dose Treatment (3 Month) Compared to the Standard Treatment for Latent TB Infection Treatment
Verified date | March 2020 |
Source | Ottawa Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase IV clinical study trial will be conducted among persons who require treatment for LTBI treatment in Iqaluit, Nunavut and Ottawa, Ontario. The primary objective of this study is to compare the proportion of people who complete directly observed prophylactic treatment (DOPT) using the new 3HP regimen to the current standard of 9 months INH.
Status | Completed |
Enrollment | 182 |
Est. completion date | August 15, 2019 |
Est. primary completion date | August 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Males or non-pregnant, non-nursing females between the ages of 2-65 years 2. LTBI diagnosis as per Canadian TB Standards using either the Tuberculin Skin Test (TST) or the Interferon Gamma Release Assay (IGRA) 3. Children 2-5 years with negative TSTs who have been in close contact with a case of active TB disease recently 4. Able and willing to provide fully informed consent or parent/guardian able to provide consent Exclusion Criteria: 1. Suspected or confirmed active TB disease 2. Known allergies to any of the study medications by participant self-report 3. Female participants of childbearing potential who: 1. have a positive pregnancy test at screening, or 2. are not willing to use a reliable method of barrier contraception during the study, or 3. are breastfeeding 4. Unable/unwilling to substitute medications with drug interactions with 3HP, including : 1. hormonal contraception 2. HIV infected participants who are on anti-retroviral drugs 3. other drugs that interact with 3HP (see Table 1) 5. Known contact with an INH or rifampin resistant case 6. Weight < 10 kg 7. Evidence of possible liver damage defined by an aspartate transaminase (AST) level that is more than 3x the upper limit of normal in an asymptomatic patient 8. Porphyria reported by patient 9. Inability to adhere to protocol. 10. Patients may be excluded from the study for other reasons, at the investigator's discretion with detailed documentation. |
Country | Name | City | State |
---|---|---|---|
Canada | The Ottawa Hospital - General Campus | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute | Government of Canada, Government of Nunavut |
Canada,
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 months of rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med. 2011 Dec 8;365(23):2155-66. doi: 10.1056/NEJMoa1104875. — View Citation
Villarino ME, Scott NA, Weis SE, Weiner M, Conde MB, Jones B, Nachman S, Oliveira R, Moro RN, Shang N, Goldberg SV, Sterling TR; International Maternal Pediatric and Adolescents AIDS Clinical Trials Group; Tuberculosis Trials Consortium. Treatment for preventing tuberculosis in children and adolescents: a randomized clinical trial of a 3-month, 12-dose regimen of a combination of rifapentine and isoniazid. JAMA Pediatr. 2015 Mar;169(3):247-55. doi: 10.1001/jamapediatrics.2014.3158. Erratum in: JAMA Pediatr. 2015 Sep;169(9):878. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Completion of treatment | Participants who start and complete treatment | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05738681 -
Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial
|
Phase 2/Phase 3 | |
Recruiting |
NCT05526885 -
Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa
|
N/A | |
Completed |
NCT04369326 -
Community Initiated Preventive Therapy for TB
|
N/A | |
Recruiting |
NCT04568967 -
TB-CAPT EXULTANT - HIV
|
N/A | |
Completed |
NCT02337270 -
Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol
|
Phase 1 | |
Not yet recruiting |
NCT06253715 -
Shortened Regimen for Drug-susceptible TB in Children
|
Phase 3 | |
Recruiting |
NCT04271397 -
Immunological Biomarkers in Tuberculosis Management
|
N/A | |
Withdrawn |
NCT03639038 -
Tuberculosis Diagnosis by Flow Cytometry
|
||
Completed |
NCT03199313 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid
|
Phase 1 | |
Recruiting |
NCT04975178 -
Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
|
Phase 3 | |
Completed |
NCT04463680 -
Rifampin and the Contraceptive Implant
|
Phase 4 | |
Completed |
NCT03973970 -
Assessing the Ability of the T-SPOT®.TB Test (IQ)
|
||
Recruiting |
NCT04230395 -
Alcohol Reduction Among People With TB and HIV in India
|
N/A | |
Completed |
NCT04874948 -
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
|
Phase 1 | |
Active, not recruiting |
NCT02906007 -
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05917210 -
Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
|
N/A | |
Not yet recruiting |
NCT05845112 -
Start Taking Action For TB Diagnosis
|
||
Not yet recruiting |
NCT06017843 -
Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding
|
N/A | |
Active, not recruiting |
NCT02715271 -
Study of TB Lesions Obtained in Therapeutical Surgery
|
||
Completed |
NCT02781909 -
Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis
|
Phase 2 |