None listed
Conditions
Interventions
Group 1 Type of group
RFT 900 mg once weekly for 12 directly observed doses (3 months) for people weighing> 50.0 kg. MORE INH 15 mg / kg (rounded to the nearest value of 50 or 100 mg
900 mg maximum) once weekly for 12 directly observed doses if> 12 years of age. INH 25 mg / kg (rounded to the nearest value of 50 or 100 mg
Group 2 Type of group
INH will be given 5 mg / kg (rounded to the nearest value of 50 or 100 mg
maximum 300 mg) daily for 270 self-administered doses (9 months). For children 2—11 years, INH 10-15 mg / kg (rounded to the nearest value of 50 or 100 mg
300 mg maximum).
Sponsors
Institutos Nacionales de Salud (NIH, siglas en ingles) de los Estados Unidos de America,
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • Children 2 -11 years of age and people infected with HIV> 2 years of age • People reactive to the Tuberculin dermoreaction test (PPD) with a high risk of developing TB without evidence of active TB. A high-risk reactive person is defined as: 1. Household members and other close contacts of people with confirmed TB culture who are TST-positive as part of a contact investigation within two years of the enrollment date. A close contact is defined as one with> 4 hours in a shared airspace, for a period of one week. Among the close contacts, a positive TST is defined as one with> 5 mm of induration after 5 UT of PPD placed intradermically using the Mantoux technique. 2. TST converters - which converted from documented negative to a positive TST within a period of two years. It is defined as a person with a Tuberculin dermal test> 10 mm within two years after a non-reactive test or a person with an increase of> 10 mm within a period of two years. 3. HIV seropositive people, positive TST (> 5 mm induration). 4. People with> 2 cm * of parenchymal pulmonary fibrosis on chest radiography, no previous history of TB treatment,> 5 mm of induration in TST, and 3 sputum cultures negative for M. tuberculosis in the final report. 5. Children> 2 but 10 mm induration in TST, regardless of the history of TB exposure. • Close HIV-seropositive contacts of people with culture-confirmed TB, regardless of the condition of TST. In addition, close HIV-seropositive contacts of people with culture-confirmed TB who have a documented history of having completed a course of treatment suitable for active TB infection or latent TB are also eligible. • Children> 2 but <5 years of age with a negative initial TST who are close contacts of a culture-confirmed case of TB. • Desire to provide signed informed consent, or parental consent and participant acceptance.
Exclusion criteria
Exclusion criteria: • Current TB confirmed with culture-positive or by clinical criteria • Suspicion of TB (as defined by the site researcher) or Isoniazid or rifampicin resistant tuberculosis in the source case • A history of treatment for> 14 consecutive days with a rifamycin or> 30 consecutive days with INH during the previous 2 years. • A documented history of having completed a course of treatment suitable for active TB or latent TB infection in a person who is HIV-seronegative. • History of susceptibility / intolerance to isoniazid or rifamycins. • Serum aspartate aminotransferase (AST, SGOT)> 5x the upper normal limit between people who were determined AST. • Pregnant or lactating women. • People who currently receive or plan to receive anti-retroviral therapy (eg, HIV 1 protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, CCR5 inhibitors or integrase inhibitors) in the first 90 days after enrollment. • Weight <10.0 kilograms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Through the cultivation or clinical evaluation of signs and symptoms Measure:Development of culture-confirmed tuberculosis in people> 18 years and the development of culture-confirmed or probable (clinical) tuberculosis in people <18 years of age. Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Through the cultivation or clinical evaluation of signs and symptoms Measure:Development of combined culture-confirmed or probable tuberculosis (regardless of age). Timepoints:During the study ; Outcome name:Emergence of adverse events related to the study drug. Measure:Development of any degree of toxicity 3 or 4 related to the drug. Timepoints:During the study ; Outcome name:Death event due to any cause Measure:Death due to any cause (toxicity grade 5). Timepoints:During the study | — |
Contacts
Public ContactPablo E. Campos
ASOCIACION CIVIL IMPACTA, SALUD Y EDUCACION
Outcome results
None listed