CTRI/2017/07/009119招募中3 期
A randomized trial of therapy shortening for minimal tuberculosis with new WHO-recommended doses / fixed-dose-combination drugs in African / Indian HIV+ and HIV- children : SHINE study. - SHINE STUDY
niversity College London0 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
- 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
- •1. Age 0-16 years
- •2. Weight >= 3kg. This has been expanded to include children weighing between 3 and 4kg; a detailed PK study of individual drugs in infants is ongoing and data using the new FDC from this study will ensure that use of this new formulation is also studied in these smallest infants.
- •3. Clinician has decided to treat with standard first-line regimen (intensive phase of 4 drugs or 3 drugs as per local practice)
- •4. Symptomatic but non-severe TB including:
- •a. extrathoracic lymph node TB; intra-thoracic uncomplicated (hilar) lymph node TB
- •b. minimal or no parenchymal abnormality on CXR
- •c. smear gastric aspirate/other respiratory sample (minimum 2 samples) negative
- •Note: GeneXpert may be positive or negative; culture of respiratory sample may be positive or negative; lymph node aspirate may be smear/culture/GeneXpert positive or negative)
- •5. Not previously treated for TB or successfully treated for TB > 2 years since last completed treatment
- •6. Known HIV status; HIV-infected or HIV-uninfected
- •7. Willing and likely to adhere to 72 weeks follow up
- •8. Informed written consent from the parent/legal caregiver(s) and assent in children, as per local Ethics Committee guidance
- •9. Home address accessible for visiting and intending to remain within the recruitment area for follow up
- •10. Since participants will all be under legal age of independent consent, a parent or legal guardian must be willing and able to provide informed consent. If the subject is of appropriate age, she/he will also be asked to give assent if developmentally appropriate and clinically possible.
- •11. Participant can comply with the protocol requirements in the opinion of the site investigator.
排除标准
- •1.Smear-positive respiratory sample TB (note: smear-positive peripheral lymph node sample is allowed)
- •2. Premature ( <37 weeks) and aged under 3 months
- •3. Miliary TB, spinal TB, TB meningitis, osteo articular TB, abdominal TB, congenital TB
- •4. Pre-existing non-tuberculous disease likely to prejudice the response to, or assessment of, treatment e.g. liver or kidney disease, peripheral neuropathy, cavitation
- •5. Any known contraindication to taking anti-TB drugs
- •6. Known contact with drug resistant adult source case (including mono-resistant TB)
- •7. Known drug resistance in the child
- •8. Severely sick
- •9. Pregnancy
- •10. A clinically significant active medical condition or the presence of any concomitant severe illness or rapidly deteriorating health condition (outside of TB), which, in the opinion of the site investigator, would prevent appropriate participation in the trial, or that would make implementation of the protocol or interpretation of the study results difficult, or otherwise make the subject a poor candidate for a clinical trial.
研究者
相似试验
尚未招募
不适用
Shorter treatment for minimal TB in childrePaediatricsTuberculosisPACTR201505001141379niversity College London1,200
尚未招募
1 期
A randomized controlled clinical study on minimally invasive acupoint cat-embedding intervention for metabolic abnormalities of chronic kidney diseaseChronic kidney diseaseITMCTR2000003830Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
已完成
不适用
A randomized controlled trial of reducing effect of postoperative epidural haematoma formation by the use of gelatin hemostatic matrix with human thrombin (FloSeal) in cases with lumbar spinal canal stenosis treated by microendscopic surgerylumbar spinal canal stenosisJPRN-UMIN000026255Department of orthopaedic surgery, Wakayama Medical University60
已完成
3 期
Randamized clinical trial of reduction in the recurrence of acute noncardioembolic stroke by Cilostazol and Eicosapentaneic acid for hypercholesterolemic patientson-cardioembolic cerebral infarctionJPRN-UMIN000013864Department of Neurology, Tokyo Medical University500
招募中
不适用
Prospective randomized controlled trial of minimally invasive robotic- vs. fluoroscopic-assisted open pedicle screw placement in adult degenerative spinal fusion surgeriesDiseases of the musculo-skeletal system and connective tissueKCT0000993Seoul National University Bundang Hospital60