Status:
COMPLETED
The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB
Lead Sponsor:
Beijing Chest Hospital
Conditions:
Multi-drug Resistant Tuberculosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
WHO has recommended that multidrug-resistant tuberculosis (MDR-TB, defined as resistance to at least isoniazid (H) and rifampicin (R) be addressed as a public health crisis and enhance capacity to del...
Detailed Description
1. Design: the study is a multi-center,open, single arm trial. 2. Population:patients with sputum culture positive and confirmed as MDR-TB via drug resistance of isoniazid(H),rifampicin(R),ethambutol(...
Eligibility Criteria
Inclusion
- Is willing and able to give informed consent to participate in the trial treatment and follow-up.
- Is aged between 18 years and 70 years.
- Has a positive sputum culture result or a positive GeneXpert result.
- Has evidence of RR-TB or MDR-TB either by GeneXpert or culture-based drug susceptibility testing (DST).
- Non pre-XDR-TB or XDR-TB.
- Is willing to use effective contraception of women at childbearing age.
- Has had a chest X-ray that is compatible with a diagnosis of pulmonary TB.
Exclusion
- pre-XDR-TB or XDR-TB.
- Has a known allergy to any drug of the regimen.
- Is currently taking or took part in another trial less than three months before the study initiation .
- Is HIV positive.
- Has abnormal ECG with QT prolongation over 430ms of men while 450 of women.
- Is critically ill, and in the judgment of the investigator, unlikely to take part in the study.Or has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe.
- Is known to be pregnant or breast-feeding.
- Has severe cardiovascular diseases, such as heart failure, hypertension (poor blood pressure control), arrhythmia or post-infarction status.
- Has severe concomitant severe disease such as respiratory failure or cardiac insufficiency or liver and kidney injury with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 2.5 times the upper limit of normal or with serum creatinine(Cr)more than 1.3 times the upper limit of normal.
- Has Karnofsky score less than 50%
Key Trial Info
Start Date :
March 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2022
Estimated Enrollment :
515 Patients enrolled
Trial Details
Trial ID
NCT03830671
Start Date
March 8 2019
End Date
June 8 2022
Last Update
October 12 2022
Active Locations (20)
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1
Beijing Chest Hospital
Beijing, China
2
The 8th Medical Center of Chinese Pla General Hospital
Beijing, China
3
Changchun Infectious Disease Hospital
Changchun, China
4
Hunan Institute For Tuberculosis Control
Changsha, China