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Prospective Randomized Control Non-inferiority Study of the Use of Faropenem for Patients with etiology Positive Pulmonary Tuberculosis

Prospective Randomized Control Non-inferiority Study of the Use of Faropenem for Patients with etiology Positive Pulmonary Tuberculosis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015959
Enrollment
Unknown
Registered
2018-05-02
Start date
2018-05-15
Completion date
Unknown
Last updated
2022-01-18

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

Conditions

Newly diagnose etiology positive pulmonary tuberculosis

Interventions

experimental group:Faropenem-based Regimen
control group:Standardized Regimen

Sponsors

Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed and untreated pulmonary tuberculosis patients with etiology positive pulmonary tuberculosis; 2. Aged between 18 and 80 years; 3. Positive results on sputum smears on two occasions; 4. Sputum was confirmed by MTB/RIF GeneXpert or detection sputum culture positive; 5. The identification of bacteria type is Mycobacterium tuberculosis; 6. Radiological examination of the lungs with lesions; 7. Non-infected the human immunodeficiency virus; 8. Sputum culture-confirmed susceptibility to rifampin, isoniazide and fluoroquinolones; 9. Women of childbearing age, that the urine analysis of whom are negative and agree to use the efficient contraception during the study period.

Exclusion criteria

Exclusion criteria: 1. Combined with extra pulmonary tuberculosis; 2. Allergic to any drug of treatment regimens; 3. Combined liver, kidney, metabolism, autoimmune diseases, endocrine, blood, nervous system diseases, mental disease, malignant tumor, long-term use of immunosuppressive agents; 4. HIV/AIDS patients; 5. Complication with Diabetic; 6. Being or breast-feeding; 7. Has Non-tuberculous mycobacterial disease; 8. Diagnosis was isoniazid resistance or rifampin resistance; 9. Patients who are not suitable for the study or who may not be able to complete the whole course of treatment, according to the researchers' judgment; 10. Attending any other clinical research simultaneously; 11. Those who gave up and withdrew halfway after joining the group participated in other clinical trials but had poor compliance.

Design outcomes

Primary

MeasureTime frame
the rate of conversion at the end of the course of treatment;Cure rate;Recurrence rate;The rate of adverse event;

Countries

China

Contacts

Public ContactKaijin XU

Zhejiang University

zdyxyxukaijin@163.com+86 13750870030

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026