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Clinical study of SPSA in the treatment of multidrug - resistant pulmonary tuberculosis

Clinical study of SPSA in the treatment of multidrug - resistant pulmonary tuberculosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONh-17011976
Enrollment
Unknown
Registered
2017-07-13
Start date
2017-07-01
Completion date
Unknown
Last updated
2017-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multidrug-resistant tuberculosis

Interventions

SASP:SASP

Sponsors

The Fifth People's Hospital of Suzhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. voluntarily as the subject of the test, signed informed consent; 2. aged between 18-65 years (resistant to anti-tuberculosis drugs, the age may be appropriate to relax), men and women are not limited, including hospital and outpatients; 3. multidrug-resistant tuberculosis treatment failure, can not be in accordance with the standard anti-drug program anti-tuberculosis patients; 4. improved Roche culture drug susceptibility test results were diagnosed with MDR-PTB patients; 5. women of childbearing age pregnancy negative urine test and agreed to use during the study of effective contraceptive measures.

Exclusion criteria

Exclusion criteria: 1. With a history of allergy to the study drug or any of its ingredients; 2. To be currently associated with severe comorbidities or impaired renal function (serum creatinine levels =265 umol / L) or impaired liver function (ALT and / or AST levels 2.5 times the upper limit of laboratory reference); 3. patients with FQs, clinically significant ECG abnormalities (male patients QT interval prolonged more than 430 milliseconds, female patients QT interval extended more than 450 milliseconds); 4. have a history of cardiovascular disease or are suffering from such diseases, such as heart failure, high blood pressure (poor blood pressure control), arrhythmia or post-myocardial infarction state; 5. pregnant or lactating women; 6. According to the task group to determine the subjects suffering from not suitable for participation in the subject or may make the patient can not participate in the whole process of any disease.

Design outcomes

Primary

MeasureTime frame
CT;Sputum culture;

Secondary

MeasureTime frame
T cell surgroup;

Countries

China

Contacts

Public ContactMeiying Wu

The Fifth People's Hospital of Suzhou

wu_my@126.com+86 051265189997

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026