PER-004-19招募中未知
PROTECTING HOUSEHOLDS ON EXPOSURE TO NEWLY DIAGNOSED INDEXMULTIDRUG-RESISTANT TUBERCULOSIS PATIENTS (PHOENIx MDR-TB)
Division de SIDA de los Institutos Nacionales de Salud (USA),0 个研究点目标入组 0 人开始时间: 2019年5月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 <5
- •years old at the time of enrollment, regardless of TST, IGRA, or HIV status;
- •Adults, adolescents, and children ≥5 years of age who are TST-positive
- •(≥5 mm) and/or IGRA-positive and whose HIV status is negative,
- •indeterminate, or unknown, and who are not non-HIV immunosuppressed;
- •Adults, adolescents, and children ≥5 years of age who are HIV-infected
- •or are non-HIV immunosuppressed (defined as receiving anti-tumor
- •necrosis factor (TNF) treatment, or being solid organ or hematologic
- •transplant recipients), regardless of TST or IGRA status. 8 HIV-1 infection
- •status must be documented as positive, negative, indeterminate or
- •unknown for all HHCs. Unknown status includes those who previously
- •tested HIV-negative but the test was performed more than one year ago.
- •HIV testing will be offered to all HHCs with negative or unknown status.
- •For adults (18 years and older), HIV-1 infection must be documented by
- •any licensed rapid HIV test or HIV enzyme or chemiluminescence
- •immunoassay (E/CIA) test kit at any time prior to study entry and
- •confirmed by a licensed Western blot or a second antibody test by a
- •method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen
- •or plasma HIV-1 RNA viral load >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 HI
排除标准
- •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).
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