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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

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Baoshan People's Hospital
Coordinator of this site? Confirm its status
BaoshanChinaUnknown status
Hunan Chest Hospital
Coordinator of this site? Confirm its status
ChangshaChinaUnknown status
Guiyang Public Health Treatment Center
Coordinator of this site? Confirm its status
GuizhouChinaUnknown status
Hangzhou Red Cross Hospital
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Huaihua first people's Hospital
Coordinator of this site? Confirm its status
HuaihuaChinaUnknown status
Yunnan Provincial Infectious Disease Hospital
Coordinator of this site? Confirm its status
KunmingChinaUnknown status
Jiangxi Chest Hospital
Coordinator of this site? Confirm its status
NanchangChinaUnknown status
Hwa Mei Hosptal,University of Chinese Academy of Sciences(Ningbo No.2 Hospital)
Coordinator of this site? Confirm its status
NingboChinaUnknown status
Huashan Hospital of Fudan University
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ShanghaiChinaUnknown status
The Third People's Hospital of Shenzhen City
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ShenzhenChinaUnknown status
Taizhou Enze medical center Enze Hospital
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TaizhouChinaUnknown status
Chest Hospitalof Xinjiang Uygur Autonomous Region of PRC
Coordinator of this site? Confirm its status
ÜrümqiChinaUnknown status
The Central Hospital of Wenzhou City
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WenzhouChinaUnknown status
Shanxi Provincial Tuberculosis Control Institute
Coordinator of this site? Confirm its status
Xi’anChinaUnknown status
The Sixth People's Hospital of Zhengzhou
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.