CTRI/2020/03/024046尚未招募3 期
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB) - PHOENIx MDR-TB
IAID National Institute of Child Health and Human Development0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 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
- •1. 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 one-week period prior to the index case starting MDR-TB treatment.
- •2. HHCs must be in one of the following high-risk groups:
- •a) All children 0 to <5 years old at the time of enrollment,regardless of TST, IGRA, or HIV status;
- •b) 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;
- •c) Adults, adolescents, and children >=5 years of age who are HIV-infectedor 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.
- •3. HIV-1 infection status must be documented as positive, negative, indeterminate or unknown.
- •4.The following specific laboratory values for infants, children and adults obtained within 30 days prior to study entry by any DAIDS-approved non-US laboratory that operates in accordance with GCLP and participates in appropriate external quality assurance programs.
- •a) Absolute neutrophil count (ANC) >=750 cells/mm3
- •b) Hemoglobin >=7.4 g/dL
- •c) Platelet count >=50,000/mm3
- •d) Creatinine <=2 Ã? upper limit of normal (ULN)
- •e) Potassium level >=3.0 mEq/L
- •f) Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), <=3 Ã? ULN
- •g) Total bilirubin <= 2.5 Ã? ULN (Note: if on atazanavir (ATV), total bilirubin >2.5 x ULN permitted if direct bilirubin <=2.5 Ã? ULN)
- •h) Albumin >3 g/dL
- •5.For females of reproductive potential, negative serum or urine pregnancy test within 7 days prior to study entry by any DAIDS-approved non-US laboratory that operates in accordance with GCLP and participates in appropriate external quality assurance programs.
- •6.For infants (0 to 1 year of age), weight >=2.5kg at screening.
- •7.Ability and willingness of participant or legally-authorized representative (legal guardian or biological parent) to provide informed consent or assent as appropriate.
- •8.Chest radiograph without evidence of active TB performed within 70 days prior to study entryforHHCs >=2years of ageand within 30 days prior to study entry for HHCs <2 years of age.
- •9. QTcFinterval <=460ms within 30 days prior to study entry as confirmed by the central ECG reading center.
- •10.Enrollment of the HHC within 30 days after the index case is enrolled. In the event that a HHC is suspected of having TB, then this window for enrollment may be extended from within 30 days to within 70 days to allow for TB testing of the HHC.
排除标准
- •1.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 >=15years of age; or the modified pediatric TB definitions for children <15 years of age as described in the A5300B/I2003B/PHOENIx MOPS.
- •2.Receipt of more than 30 cumulative days of INH, rifamycin, fluoroquinolone, or DLMin the 90 days prior to study entry.
- •3.History of or current liver cirrhosis at any time prior to study entry.
- •4.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.
- •5.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.
- •6.Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.
- •7.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.
- •8.Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- •9.Serious illness requiring systemic treatment including parenteral therapy(e.g., antibiotics)and/or hospitalization within 30 days prior to study entry.
- •10.Currently receiving other medication with potential for adverse drug-drug interactions, including QT prolongation. Please see the list of prohibited medications.
- •11.Taken an investigational drug or vaccine within 30 days prior to study entry.
- •12.Has a clinical condition that in the site investigatorâ??s opinion would interfere with study participation.
- •13.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.
- •14.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).
研究者
相似试验
尚未招募
3 期
A5300B/I2003B/PHOENIxTuberculosisPACTR202101800561159ational Institute of Allergy and Infectious Diseases and National Institute of Child Health and Human Development5,610
招募中
不适用
PROTECTING HOUSEHOLDS ON EXPOSURE TO NEWLY DIAGNOSED INDEXMULTIDRUG-RESISTANT TUBERCULOSIS PATIENTS (PHOENIx MDR-TB)-A15 Respiratory tuberculosis, bacteriologically and histologically confirmedRespiratory tuberculosis, bacteriologically and histologically confirmedA15PER-004-19Division de SIDA de los Institutos Nacionales de Salud (USA),
招募中
不适用
ifestyle modification for Prevention of non-communicable disorders: Intervention phase of the Tehran Lipid and Glucose Study (phase II)ifestyle modification interventions in preventing or postponing the development of NCD risk factors and outcomes with special focus on angina pectoris, myocardial infarction, cerebrovascular events, diabetes mellitus, hypertension and dyslipidemia..IRCT138705301058N1research institute for endocrine sciences15,005
已完成
不适用
Prevention of disease flares by risk-adapted stratification of therapy withdrawal in juvenile idiopathic arthritis (JIA)juvenile idiopathic arthritisNL-OMON40476Westfaelische Wilhelm Universitaet33
进行中（未招募）
不适用
Prevention of disease flares by risk-adapted stratification of therapy withdrawal in juvenile idiopathic arthritis (JIA)MedDRA version: 16.1Level: LLTClassification code 10059177Term: Juvenile arthritisSystem Organ Class: 100000004859juvenile idiopathic arthritisEUCTR2013-003956-18-NLniversity Medical Center Utrecht325