NCT04717908Completed
Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)-PLUS
Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T) (TB-TRUST)-PLUS
Source: ClinicalTrials.gov · Last updated 12 Nov 2024
Brief summary (registry, in English)
The purpose of this study is to assess the efficacy, safety and tolerability of a combination of bedaquiline, linezolid, cycloserine, clofazimine and pyrazinamide treatments guided by PZA sensitivity for 24 to 36 weeks in subjects with fluoroquinolone-resistant MDR-TB .
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 89 (actual)
- First submitted
- 17 Jan 2021
- Start date
- 20 Jan 2021
- Primary completion date
- 22 Jun 2024
- Lead sponsor
- Huashan Hospital
- Diseases
- Tuberculosis
- NCT number
- NCT04717908
What you commit to
- Study type: Interventional
- Participants enrolled: 89
- From 20 Jan 2021 to the primary completion date, 22 Jun 2024
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Can not take oral medications;
- Simultaneously apply the drugs (glucocorticoids, interferons) that affect the efficacy of this study; and apply the following drugs contraindicated with the study drug, including non-steroidal anti-inflammatory drugs, monoamine oxidase inhibitors (phenethyl hydrazine, different Carbofurs et al), direct or indirect sympathomimetic drugs (such as pseudoephedrine), vasopressor drugs (such as adrenaline, norepinephrine), dopamine drugs (such as dopamine, dobutamine), 5 a serotonin reuptake inhibitor, a tricyclic antidepressant, a serotonin 5-HTI receptor antagonist (amitriptyline), meperidine or buspirone.
- Currently participating in another drug clinical trial;
- Subjects receive more than 2 weeks of bedaquiline, linezolid, cycloserine, clofazimine or pyrazinamide 3 months prior to enrolment.
Other illness
- Combined extrapulmonary tuberculosis;
- HIV antibody positive and AIDS patients;
- The investigator believes that there are any social or medical conditions that expose the subject to a safety hazard;
- Being allergic or intolerant of any study drug;
- Have epilepsy, severe depression, irritability or psychosis;
Lab values
- Patients with impaired liver function (hepatic encephalopathy, ascites; total bilirubin is more than 2 times higher than the upper limit of normal; ALT or AST is more than 5 times the upper limit of normal);
- QTc interval ≥ 500 milliseconds during screening;
- Hemoglobin is less than 90g/L or platelet is less than 75\*10\^9/L;
Other
- Critically ill patients, and according to the judgment of the research physician, it is impossible to survive for more than 16 weeks;
- Known to be pregnant or breastfeeding;
- Unable to attend or follow treatment or follow-up time;
- Blood muscle spasm is more than 1.5 times the upper limit of normal;
- Alcohol abuse(drinking more than 64g of ethanol a day for male, 42g for female).
Who the study is looking for
- Willing to participate in trial treatment and follow-up and can give informed consent
- 18-70 years old
- Has smear-positive pulmonary tuberculosis with initial laboratory results with resistance to rifampicin and isoniazide confirmed by GeneXpert
- documented resistance to fluoroquinolones at screening
- Can use bedaquiline, linezolid, cycloserine, clofazimine and pyrazinamide drugs concerning the availability and costs of essential medicines
- Willing to carry out HIV testing.
- If the patient is a non-menopausal woman, agree to use or have used effective contraception during treatment.
- Have an identifiable address and stay in the area during the study period.
- Willing to follow the follow-up study procedure after the follow-up.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baoshan People's Hospital Coordinator of this site? Confirm its status | Baoshan | China | Unknown status |
| Hunan Chest Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Guiyang Public Health Treatment Center Coordinator of this site? Confirm its status | Guizhou | China | Unknown status |
| Hangzhou Red Cross Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Huaihua first people's Hospital Coordinator of this site? Confirm its status | Huaihua | China | Unknown status |
| Yunnan Provincial Infectious Disease Hospital Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Jiangxi Chest Hospital Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Hwa Mei Hosptal,University of Chinese Academy of Sciences(Ningbo No.2 Hospital) Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| Huashan Hospital of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The Third People's Hospital of Shenzhen City Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Taizhou Enze medical center Enze Hospital Coordinator of this site? Confirm its status | Taizhou | China | Unknown status |
| Chest Hospitalof Xinjiang Uygur Autonomous Region of PRC Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| The Central Hospital of Wenzhou City Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Shanxi Provincial Tuberculosis Control Institute Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| The Sixth People's Hospital of Zhengzhou Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.