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).

Conditions

Bacilliferous pulmonary tuberculosis

Brief summary

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.

Detailed description

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

Diab Casares L, Espinosa Pereiro J, Tórtola Fernández MT, Casas García X, Millet JP, Pomar Solchaga V, Navas Elorza E, Troya García J, Díaz de Santiago A, Luque Márquez R, Medina Gallardo JF, González Galán V, Montero Alonso M, Gil Brusola A, Rabuñal Rey R, Anibarro García L, Sanz Herrero F, Guna Serrano R, Garrigó Fullola M, Tato Díez M, Talavan Zanón T, Portero MF, Alonso García P, Saez López AM, Aznar ML, Martínez Campreciós J, Saborit N, Sánchez Montalvá A.

2025-12-07

10.1136/bmjresp-2024-002475

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGRimactan 300 mg hörð hylki.

DRUGMoxifloxacin Tillomed 400 mg film coated tablets

DRUGLINEZOLID

DRUGRIMSTAR®

DRUGCOMPRIMIDOS RECUBIERTOS CON PELÍCULA

DRUGHidroxil B1-B6-B12 comprimidos recubiertos con película

DRUGZyvoxid 600 mg Filmtabletten

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Spain

Outcome results

None listed