A15 Respiratory tuberculosis, bacteriologically and histologically confirmed Respiratory tuberculosis, bacteriologically and histologically confirmed
Conditions
Interventions
None listed
Sponsors
DIVISION DE SIDA DE LOS INSTITUTOS NACIONALES DE SALUD (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: INDEX CASE 1. Men and women age =18 years. 2. Pulmonary MDR-TB, confirmation of RIF resistance and INH resistance by: adequate source documentation , if the results are unknowlee, the clinical trial would the diagnosis. 3. Started MDR-TB treatment within the past 90 days. 4.Ability and willingness of the index case to provide informed consent to access the HH and approach HH members for evaluation. 5.HH of index case has at least one reported HHC. If any member(s) of the HH is/are not eligible or do not want to participate, all other eligible TB contacts within the HH can still participate. HOUSEHOLD CONTACTS 6 Currently lives or lived in the same dwelling unit or plot of land and shares or has shared the same housekeeping arrangements as the index case and who reports exposure within 90 days prior to the index case starting MDR-TB treatment. Also, shared >4 hours of indoor airspace with the index case during any oneweek period prior to the index case starting MDR-TB treatment. 7 HHCs must be in one of the following high-risk groups: • All children 0 to 1000 copies/mL. Two or more plasma HIV-1 RNA viral loads of >1000 copies/mL are also acceptable as documentation of HIV infection. NOTE: The term “licensed” refers to a US FDA-approved kit or, for sites located in countries other than the United States, a kit that has been certified or licensed by an oversight body within that country and validated. US FDA-approved methods are preferred. NOTE: Results can be abstracted from the medical record to meet criteria for HIV diagnosis. HIV-Infected Infants 0-2 Years of Age An infant is considered to be infected with HIV if two separate peripheral blood specimens from different days are drawn and each specimen is positive by at least one of the following assays: • HIV DNA PCR • Plasma HIV RNA (quantitative or qualitative) • HIV total nucleic acid tests At least one of the above tests must be done in a VQA-certified laboratory that is approved to perform the assay for protocol testing. If the mother or infant is receiving ARV drugs, then an HIV DNA assay is the preferred test (more sensitive). HIV-Uninfected Infants 0-2 Years of Age A non-breastfed infant born to an HIV-infected mother is considered to be uninfected with HIV when two separate periphera
Exclusion criteria
Exclusion criteria: INDEX CASE 1 Has previously enrolled into the A5300B/I2003B/PHOENIx trial as an index case or HHC, or is a member of a HH which has previously enrolled into the A5300B/I2003B/PHOENIx trial. HOUSEHOLD CONTACTS 2 Current confirmed or probable or possible pulmonary or extrapulmonary TB, based on the following criteria: the current ACTG Diagnosis Appendix 100 for adults and for children of =15 years of age; or the modified pediatric TB definitions for children <15 years of age as described in the A5300B/I2003B/PHOENIx MOPS. 3 Receipt of more than 30 cumulative days of INH, rifamycin, fluoroquinolone, or DLM in the 90 days prior to study entry. 4 History of or current liver cirrhosis at any time prior to study entry. 5 Evidence of acute hepatitis, such as abdominal pain, nausea and vomiting, jaundice, dark urine, and/or light stools within 90 days prior to study entry. 6 Peripheral neuropathy =Grade 2 within 90 days prior to study entry according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017. 7 Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation. 8 Current cardiovascular disorder that is clinically relevant in the opinion of the site investigator, including but not limited to heart failure, coronary heart disease, second or third degree atrioventricular (AV) block, prolongation of the QRS complex over 120 ms (in both male and female participants), arrhythmia, or tachyarrhythmia. 9 Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. 10 Serious illness requiring systemic treatment including parenteral therapy (e.g., antibiotics) and/or hospitalization within 30 days prior to study entry. 11 Currently receiving other medication with potential for adverse drug-drug interactions, including QT prolongation. Please see section 5.4 for a list of prohibited medications. 12 Taken an investigational drug or vaccine within 30 days prior to study entry. 13 Has a clinical condition that in the site investigator’s opinion would interfere with study participation. 14 Has enrolled into a TB vaccine or TB preventive therapy or TB therapeutic trial, including the A5300B/I2003B/PHOENIx trial in the two years prior to study entry. 15 Not expected to be able to complete 96 weeks of study follow-up (e.g., seasonal or migrant workers or students who may not stay in the area).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events (related to treatment) that requires the permanent suspension of the study drug in patients who started treatment. NAME OF THE RESULT: Presence of adverse events PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From day 0 to week 96;Clinical and bacteriological evaluation according to age NAME OF THE RESULT: Presence of active or probable TB PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From day 0 to week 96 | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events (related to treatment) that requires the permanent suspension of the study drug in patients who started treatment. NAME OF THE RESULT: Presence of adverse events PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From day 0 to week 96;Clinical and bacteriological evaluation according to age NAME OF THE RESULT: Presence of active or probable TB PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From day 0 to week 96;Clinical evaluation NAME OF THE RESULT: Death for any reason at any time PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From day 0 to week 96;Clinical and bacteriological evaluation according to age. NAME OF THE RESULT: Death from any cause at any time between the probable active MDR-TB event at any time. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From day 0 to week 96;Record of this Adverse Events Serious or Critical NAME OF THE RESULT: Adverse event of grade 3 or more PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From day 0 to week 96;Clinical and bacteriological evaluation according to age. NAME OF THE RESULT: Active MDR-TB event confirmed PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From day 0 to week 96 | — |
Countries
Botswana, Brazil, Haiti, India, Kenya, Peru, Philippines, South Africa, Tanzania, Thailand, Uganda, Zimbabwe
Outcome results
None listed