Trials Sponsors Conditions Drugs Pricing

Conditions

Bacilliferous pulmonary tuberculosis

Outcome Measures

Primary Outcomes (1)

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 (1)

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

Interventions

Rimactan 300 mg hörð hylki.Type not reported

Moxifloxacin Tillomed 400 mg film coated tabletsType not reported

LINEZOLIDType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Rimactan 300 mg hörð hylki.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry record
Formulated product
LINEZOLID
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
COATED TABLET
View registry record
Formulated product
Zyvoxid 600 mg Filmtabletten
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Rimactan 300 mg hörð hylki.
Named ingredient: Rifampicin
View registry record
LINEZOLID
Named ingredient: Linezolid
View registry record
Zyvoxid 600 mg Filmtabletten
Named ingredient: Linezolid
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64)

You may qualify if:

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 may not qualify if:

Sponsors & Collaborators

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Type not reportedlead

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Sites (11)

Hospital General Universitario De Valencia

Valencia, 46014, Spain

Francisco Sanz Herrero961524518 fr.sanz@gmail.com

Hospital De La Santa Creu I Sant Pau

Barcelona, 08041, Spain

Virginia Pomar Solchaga935565624 vpomar@santpau.cat

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Jesús Troya García656803796

Central Study Contacts

Angélica Valderrama Rodríguez

+34677273338 aro@vhir.org

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

November 16, 2023

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2023-509075-17-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-29 06:23:55 UTC

Documents

D1_Protocol EudraCT 2021-001626-22_for publication

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.

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).

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (11)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (11)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

Locations