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NCT03867136CompletedPhase 4

Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)

Refining Multidrug Tuberculosis Treatment with the Ultra Short All Oral Regimen

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 levofloxacin, linezolid, cycloserine and pyrazinamide (or clofazimine if resistant to pyrazinamide) treatments for 24 to 32 weeks (regimen consisted of clofazimine for 36\~44 weeks) in subjects with multidrug-resistant tuberculosis (MDR-TB) compared to WHO standardized shorter regimen of 36-44 weeks.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
354 (actual)
First submitted
6 Mar 2019
Start date
1 Jun 2020
Primary completion date
10 Aug 2024
Lead sponsor
Huashan Hospital
Diseases
Tuberculosis
NCT number
NCT03867136

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 354
  • From 1 Jun 2020 to the primary completion date, 10 Aug 2024
  • 13 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;

Other illness

  • Molecular drug resistance test for infected strains resistant to second-line injection;
  • Molecular drug resistance assay for infected strains resistant to fluoroquinolone;
  • 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;
  • Alchol abuse(drinking more than 64g of ethanol a day for male, 42g for female).

Who the study is looking for

  • 1.Willing to participate in trial treatment and follow-up and can give informed consent 2.18-70 years old 3.Has smear-positive pulmonary tuberculosis with initial laboratory results with resistance to rifampicin confirmed by GeneXpert 4.Willing to carry out HIV testing. 5. If you are a non-menopausal woman, agree to use or have used effective contraception during treatment.
  • 6\. Have an identifiable address and stay in the area during the study period. 7.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 (13)

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

SiteCityCountrySite 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
Zhejiang Provincial Center for Disease Control and Prevention
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Southwest Medical University Affiliated Hospital
Coordinator of this site? Confirm its status
LuzhouChinaUnknown status
Jiangxi Chest Hospital
Coordinator of this site? Confirm its status
NanchangChinaUnknown status
Huashan Hospital of Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
The Third People's Hospital of Shenzhen City
Coordinator of this site? Confirm its status
ShenzhenChinaUnknown status
Chest Hospitalof Xinjiang Uygur Autonomous Region of PRC
Coordinator of this site? Confirm its status
ÜrümqiChinaUnknown status
The Central Hospital of Wenzhou City
Coordinator of this site? Confirm its status
WenzhouChinaUnknown status
Shanxi Provincial Tuberculosis Control Institute
Coordinator of this site? Confirm its status
Xi’anChinaUnknown status
Xuzhou Infectious Disease Hospital
Coordinator of this site? Confirm its status
XuzhouChinaUnknown 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.