PACTR202101800561159尚未招募3 期
Protecting Households On Exposure to Newly Diagnosed Index Multidrug Resistant Tuberculosis Patients (PHOENIx MDR -TB)
ational Institute of Allergy and Infectious Diseases and National Institute of Child Health and Human Development0 个研究点目标入组 5,610 人开始时间: 2020年10月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5,610
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
- 年龄范围
- 0 Day(s) 至 1 Month(s)（—）
- 性别
- All
入选标准
- •Confirmed Pulmonary MDR-TB
- •Men and women age =18 years
- •HOUSEHOLD CONTACTS
- •Children 0 to <5 years of age
- •HIV+ or non-HIV immunosuppressed adults and children =5 years of age
- •TST+ and/or IGRA+ adults and children =5 years of age not HIV+ or non-HIV immunosuppressed
- •For females of reproductive potential, negative serum or urine pregnancy test within 7 days prior to study entry
- •For infants (0 to 1 year of age), weight =2.5 kg at screening
- •Chest radiograph without evidence of active TB performed within 70 days prior to study entry for HHCs =2 years of age and within 30 days prior to study entry for HHCs <2 years of age.
- •QTcF interval =460 ms within 30 days prior to study entry as confirmed by the central ECG reading center
- •Enrollment of the HHC within 30 days after the index case is enrolled.
排除标准
- •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 CONTACT
- •Current confirmed or probable or possible pulmonary or extrapulmonary TB,
- •Receipt of more than 30 cumulative days of INH, rifamycin, fluoroquinolone, or DLM in the 90 days prior to study entry.
- •History of or current liver cirrhosis at any time prior to study entry
- •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
- •Peripheral neuropathy =Grade 2 within 90 days prior to study entry
- •Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation
- •Current cardiovascular disorder that is clinically relevant in the opinion of the site investigator
- •Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- •Serious illness requiring systemic treatment including parenteral therapy (e.g., antibiotics) and/or hospitalization within 30 days prior to study entry.
- •Currently receiving other medication with potential for adverse drug-drug interactions, including QT prolongation.
- •Taken an investigational drug or vaccine within 30 days prior to study entry.
- •Has a clinical condition that in the site investigator’s opinion would interfere with study participation.
- •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.
- •Not expected to be able to complete 96 weeks of study follow-up
研究者
相似试验
尚未招募
3 期
This is a study to compare the efficacy and safety of the drug Delamanid (DLM) versus Isoniazid (INH) for preventing Tuberculosis in Household contacts (HHCs) of adults with multidrug-resistant tuberculosis(MDR-TB). An HHC are persons who lives in the same house as the MDR-TB patient.CTRI/2020/03/024046IAID National Institute of Child Health and Human Development
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