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
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site 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 |
| Zhejiang Provincial Center for Disease Control and Prevention Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Southwest Medical University Affiliated Hospital Coordinator of this site? Confirm its status | Luzhou | China | Unknown status |
| Jiangxi Chest Hospital Coordinator of this site? Confirm its status | Nanchang | 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 |
| 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 |
| Xuzhou Infectious Disease Hospital Coordinator of this site? Confirm its status | Xuzhou | 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.