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Clinical Trials/2023-509075-17-00
2023-509075-17-00
Active, not recruiting
Phase 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:
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Overview

Phase
Phase 2
Status
Active, not recruiting
Sponsor
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
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.
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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

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

Sponsor
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Sponsor Class
Laboratory/Research/Testing facility
Responsible Party
Principal Investigator
Principal Investigator

Angélica Valderrama Rodríguez

Scientific

Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron

Study Sites (11)

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