Efficacy and Safety of Isoniazid, Rifampicin and Moxifloxacin for the Intensive Phase of Initial Therapy of PTB

• Status: Not yet recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to find an optimized initial regimen for pulmonary tuberculosis(PTB), evaluating the efficacy, safety and acceptability of isoniazid, rifampicin and moxifloxacin(HRM) for the intensive phase of initial therapy of PTB, compared with the standard initial regimen.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
• Treatments: Ethambutol; Isoniazid; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Pyrazinamide; Rifampin

Criteria

Inclusion Criteria:

• Aged 18 years or over, and an individual who completely bear the ability of civil actions.

• New cases of pulmonary tuberculosis. No previous anti-tuberculosis therapy or cumulatively taking anti-tuberculosis drugs for less than 1 month.

• Pulmonary tuberculosis patients with bacteriological diagnosis.

Exclusion Criteria:

• Suffering from tuberculous pleurisy.

• Patients with extrapulmonary tuberculosis.

• Renal insufficiency patients with creatinine clearance rate <30 ml/min.

• Abnormal liver function (ALT and/or AST and/or TBIL greater than 2 times the upper limit of normal) or decompensated cirrhosis.

• HIV-Ab positive.

• Psychiatric patients, or have a previous history of mental illness, or recently have obvious anxiety or depression and other mental abnormalities.

• Patients receiving immunosuppressive therapy.

• Pregnant or breast feeding.

• Diabetes.

• X-pert MTB/RIF test of sputum or alveolar lavage fluid showed that Mycobacterium tuberculosis was rifampin resistant.

• Moxifloxacin was used within 14 days before entering the group.

• Anti-tuberculosis treatment has been started and drugs are being taken before entering the group.

• QT interval extension > 480 ms.

• Combined with serious cardiovascular, liver, kidney, nervous system, blood system and other diseases or tumor diseases.

• Pulmonary lesions are widespread with respiratory insufficiency.

• Any other circumstances in which the anti-tuberculosis scheme of the experimental group or the control group cannot be selected for treatment.