2023-509075-17-00RecruitingPhase 2
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).
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca11 sites in 1 country120 target enrollmentStarted: November 20, 2023Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 11
- Primary Endpoint
- Efficacy: Proportion of patients with sterilization of sputum culture in liquid medium 8 weeks after starting treatment Safety: Proportion of patients with grade 3 or higher adverse events according to CTCAE V5.
Study Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age >18 years
- •Diagnosis of smear-positive pulmonary tuberculosis
- •Signature of consent form
- •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).
Exclusion Criteria
- •Recent contact with a patient with multidrug-resistant tuberculosis
- •Multidrug-resistant tuberculosis or monoresistance to any of the first-line drugs (except ethambutol)
- •Positive smear microscopy with negative mycobacterial culture.
- •Barthel <60 or the investigator considers that there is a risk of poor prognosis in the following months
- •Weight less than 40kg
- •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).
- •Cirrhosis Child C
- •User of drugs of abuse according to the researcher's criteria
- •Patient with solid organ or bone marrow transplant.
- •Patient on treatment with anti-TNF or other immunosuppressive drugs
- •Patients with oncohematological diseases Advanced lung disease according to the researcher
- •Epilepsy or non-stable psychiatric illness.
- •History of ischemic coronary heart disease or severe arrhythmia in the previous 6 months
- •Long QT syndrome or family history of sudden death
- •Patient with HIV diagnosis
- •Women who breastfeed
- •Allergy or intolerance to any of the study drugs
- •History of TB in the previous year
- •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
- •Any of the following alterations in the ECG: at QTcF>0.5sec b Other clinically relevant changes in the ECG according to the investigator.
- •Treatment with any of the drugs included in the trial for more than 7 days in the last month.
- •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.
Outcomes
Primary Outcomes
Efficacy: Proportion of patients with sterilization of sputum culture in liquid medium 8 weeks after starting treatment Safety: Proportion of patients with grade 3 or higher adverse events according to CTCAE V5.
Efficacy: Proportion of patients with sterilization of sputum culture in liquid medium 8 weeks after starting treatment Safety: Proportion of patients with grade 3 or higher adverse events according to CTCAE V5.
Secondary Outcomes
- To evaluate the tolerability of the experimental arm at 8 weeks after randomization. To evaluate the dynamics of efficacy of the experimental arm vs. control arm using the decrease in time until positive culture and time until sputum becomes negative.Analyze the correlation between the PK parameters To evaluate the quality of life of the patients. Carry out a cost-effectiveness study.To analyze the immunological and inflammatory pattern of the study participants
Investigators
Angélica Valderrama Rodríguez
Scientific
Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron
Study Sites (11)
Loading locations...
Similar Trials
Completed
Phase 3
A Study to Assess Efficacy and Safety of IV/PO Moxifloxacin in the Treatment of cSSSIsInfectious DiseasesNCT00828971Bayer16
Completed
Phase 3
A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin in Subjects With Community-acquired PneumoniaPneumoniaNCT00717561Bayer60
Completed
Phase 3
Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal InfectionIntraabdominal InfectionsNCT01069900Bayer458
Completed
Phase 2
Routine Therapy Plus Moxifloxacin in Advanced Breast CancerAntibioticStable Disease With a Trend of ProgressionAdvanced Breast CancerNCT03405168Sun Yat-sen University35
Completed
Phase 3
BAY12-8039, iv/Oral Pulmonary Abscess/Aspiration PneumoniaPneumonia, AspirationLung AbscessNCT01045902Bayer139