NCT05278988CompletedPhase 4
A Study of Ultrashort PRS Regimen V in the Treatment of MDR-TB
Source: ClinicalTrials.gov · Last updated 3 Dec 2024
Brief summary (registry, in English)
This is an exploratory, prospective, randomized, active control, and open label clinical trial to evaluate the efficacy and safety of 6-9 months treatment with the ultrashort PRS Regimen V.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 24 Feb 2022
- Start date
- 1 Apr 2021
- Primary completion date
- 30 Oct 2024
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- NCT number
- NCT05278988
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 60
- From 1 Apr 2021 to the primary completion date, 30 Oct 2024
- 1 site 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.
Other illness
- History of allergic reaction to any of the drugs used in the study;
- Pregnancy or liver, kidney, metabolic, autoimmunity, neurological, psychological or endocrine disease, blood system disease, malignant cancer, long-term users of immunosuppressant drugs.
- History of non-compliance in other clinical trials.
Lab values
- Presence of any of the following conditions that can lead to prolonged QT:
- During screening process, ECG shows QT or QTc interval ≥ 450 ms (permit one non-prescheduled retest within the screening period to re-evaluate the testees' qualification);
- Pathological Q waves (any Q wave duration of \> 40 ms or depth \> 0.4-0.5 mV);
- Evidence of ventricular pre-excitation (such as Wolff-Parkinson-White Syndrome);
- EKG shows evidence of complete or clinically significant incomplete left or right bundle branch block;
- Evidence of 2nd or 3rd degree heart block;
- Intraventricular conduction delay, QRS durations \> 120 ms;
- Slow heart rate, defined as sinus heart rate \< 50 bpm;
- Having personal or family history of long QT syndrome;
- Having heart disease, symptomatic or asymptomatic arrhythmia, excluding sinus arrhythmia;
- Fainting (i.e., cardiogenic fainting, not including vasovagal syncope or seizure)
- Having risk factors for Torsade de pointes ventricular tachycardia (e.g. heart failure, hypokalemia, hypomagnesemia)
Other
- Presence of extrapulmonary TB (including tuberculous pleurisy);
- Alcoholism
- Any patients, based on the judgement of the study medical researchers who are not suitable to participate in the trial or unlikely to complete the trial.
- Participating in another clinical trial at the same time.
Who the study is looking for
- Untreated newly diagnosed patients with rifampicin resistant (RR) or multidrug resistant (MDR)-TB.
- Newly treated patients: at least twice confirmed by molecular biology or phenotypic drug susceptibility test to have RR- or MDR-TB; Retreated patients: confirmed once by molecular biology or phenotypic drug susceptibility test to have RR- or MDR-TB.
- Age between 18 and 65.
- No abnormality on EKG.
- Able to understand and sign informed consent form.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.