ew treatment for pulmonary TB with High dose Rifampicin, High dose Moxifloxacin and Linezolid

Phase 1

• Conditions: Smear-positive rifampicin-sensitive pulmonary Tuberculosis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2021-001626-22-ES
• Lead Sponsor: Vall d'Hebron Institute of Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-29
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1) Diagnosis of AFB smear-positive pulmonary TB. 2) Age = 18 years. 3) Sign informed consent. 4) Negative pregnancy test (women of childbearing age)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1) Contact of a patient with multidrug-resistant TB. 2) Multidrug-resistant TB or monoresistance to any first-line drugs (except ethambutol). 3) AFB smear-positive pulmonary TB with negative mycobacterial culture. 4) Barthel <60 or if the investigator considers that there is a risk of death in the following month. 5) Weight <40 kg. 6) Treatment with drugs that may prolong QT in the last month before randomization for more than 7 days: randomization: azithromycin, chloroquine, chlorpromazine, cisapride, clarithromycin, domperidone, droperidol, erythromycin, halofantrine, haloperidol, lumefantrine, mefloquine, methadone, pentamidine, procainamide, quinidine, quinine, sotalol, sparfloxacin, thioridazine, amiodarone. 7) Cirrhosis Child C. 8) User of abuse drugs (including alcohol) according to investigator criteria. 9) Patients with solid organ or bone marrow transplantation. 10) Patients under treatment with anti-TNF or other immunosuppressive drugs. 11) Patients with oncohematological diseases. 12) Advanced lung disease according to investigator criteria. 13) Epilepsy or uncontrolled psychiatric disorder according to the investigator criteria. 14) History of ischemic heart disease or severe arrhythmia in the last 6 months. 15) Long QT syndrome or family history of sudden death. 16) Patient living in HIV infection. 17) Breastfeeding women. 18) Intolerance or allergy to any of the study drugs. 19) History of TB in the previous year. 20) Laboratory alterations: a) AST or ALT> 3x Upper limit of normality b) Bit> x3 Upper limit of normality c) Hb <6.5g/dl d) Platelets <40000/mm3 e) Potassium <3.2 mmol/L f) Glomerular filtration <30 mL /min/1.73m2. 21) ECG alterations: a) QTcF > 0.5s b) Other clinically relevant changes in the ECG according to investigator criteria. 22) Treatment with any of the study drugs in the last month for more than 7 days.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified