CTIS2023-509075-17-00招募中1 期
RANDOMIZED, CONTROLLED, OPEN, MULTICENTRIC CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A COMBINATION OF ANTI-TUBERCULOUS DRUGS BASED ON HIGH DOSE RIFAMPICIN, HIGH DOSE MOXIFLOXACIN AND LINEZOLID IN PATIENTS WITH BACILLIFEROUS PULMONARY TUBERCULOSIS (RML-TB). - RML-TB
Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron0 个研究点目标入组 120 人开始时间: 2023年11月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
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
- 18 至 64（—）
- 性别
- All
入选标准
- •1. Age >18 years 2. Diagnosis of smear-positive pulmonary tuberculosis 3. Signature of consent form 4. Negative pregnancy test in women of childbearing age (defined as a woman who has had menarche and has not yet had menopause, with the exception of infertile women, which includes, among other situations, women with a hysterectomy, women with a double salpingectomy and women with double oophorectomy).
排除标准
- •1. Recent contact with a patient with multidrug-resistant tuberculosis 2. Multidrug-resistant tuberculosis or monoresistance to any of the first-line drugs (except ethambutol) 3. Positive smear microscopy with negative mycobacterial culture. 4. Barthel <60 or the investigator considers that there is a risk of poor prognosis in the following months 5. Weight less than 40kg 6. Treatment with drugs that can prolong QT in the last month before randomization for more than 7 days (azithromycin, chloroquine, chlorpromazine, cisapride, clarithromycide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, lumefantrine, mefloquine, methadone, pentamidine, procainamide, quinidine, quinine, sotalol, sparfloxine, thioridazine, amiodarone). 7. Cirrhosis Child C 8. User of drugs of abuse according to the researcher's criteria 9. Patient with solid organ or bone marrow transplant. 10. Patient on treatment with anti-TNF or other immunosuppressive drugs 11. Patients with oncohematological diseases Advanced lung disease according to the researcher 13. Epilepsy or non-stable psychiatric illness. 14. History of ischemic coronary heart disease or severe arrhythmia in the previous 6 months 15. Long QT syndrome or family history of sudden death 16. Patient with HIV diagnosis 17. Women who breastfeed 18. Allergy or intolerance to any of the study drugs 19. History of TB in the previous year 20. Any of the following laboratory alterations: AST or ALT > 3 times the upper limit of normal b Total Bi > 3 times the upper limit of normal c Hb< 6.5 g/dl d Platelets < 40,000/mm^3 e Potassium < 3.2 mmol/L f GFR<30 ml/min/1.73m^2 21. Any of the following alterations in the ECG: at QTcF>0.5sec b Other clinically relevant changes in the ECG according to the investigator. 22. Treatment with any of the drugs included in the trial for more than 7 days in the last month. 23. Participants who are being treated with serotonin reuptake inhibitors, tricyclic antidepressants, serotonin 5HT1 receptor agonists (triptans), direct or indirect acting sympathomimetics (including adrenergic bronchodilators, pseudoephedrine and phenylpropanolamine), vasopressors (e.g. epinephrine, norepinephrine), dopaminergic medications (e.g. dopamine, dobutamine), pethidine or buspirone and cannot be removed or replaced by drugs of another class at the discretion of the investigator.
研究者
相似试验
招募中
4 期
A randomized, controlled, open, multi-center clinical study on the effectiveness and safety of Kangai injection in the treatment of cancer-induced fatigueTumor patients (lung cancer, rectal cancer, malignant lymphoma, gynecological malignancy)ITMCTR2100004974Jiangsu Provincial Hospital of Traditional Chinese Medicine
进行中（未招募）
1 期
MULTICENTER, RANDOMIZED, BLIND AND CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY IN THE CORRECTION OF DEFICIT IN SUBJECTS WITH SEVERE VITAMIN D DEFICIENCY. DTREAT STUDY.CTIS2024-514528-17-00Itf Research Pharma S.L.120
招募中
1 期
A prospective, randomized,open, multi-center clinical trial evaluating the efficiency and safety of Reduning injection in the treatment of novel coronavirus pneumonia (COVID-19)novel coronavirus pneumonia (COVID-19)ITMCTR2000002972Beijing hospital of Traditional Chinese Medicine
已完成
3 期
Recombinant Human Chorionic Gonadotropin in InfertilityCTRI/2014/09/005010Bharat Serums and Vaccines Ltd217
已完成
3 期
MULTICENTER, RANDOMIZED, OPEN COMPARATIVE CLINICAL STUDY OF THE EFFICACY AND SAFETY OF GYNOMAX XL, VAGINAL SUPPOSITORIES manufactured by EMBIL ILAÇ SANAYI Ltd., Sti (Turkey) with Gynomax, vaginal suppositories manufactured by Embil Ilaç Sanayi Ltd., Sti (Turkey) in the therapy of vulvovaginal candidiasis, bacterial vaginitis, trichomonadal vaginitis or mixed vaginal infectionsA59B37.3N76Candidiasis of vulva and vaginaOther inflammation of vagina and vulvaTrichomoniasisDRKS00016648Exeltis Healthcare S.L. (Spain) Moscow representative office of Exeltis Healthcare S.L. (Spain)140