Ended Therapeutic exploratory (Phase II) Bacilliferous pulmonary tuberculosis

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).

EU CTIS ID: 2023-509075-17-00

What this study is testing

To evaluate the efficacy and safety of a regimen based on high-dose rifampicin, high-dose moxifloxacin and linezolid for 8 weeks versus standard treatment in patients with smear-positive pulmonary tuberculosis.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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).

You likely can't join if

  • 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.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.