The Optimal Duration of Preoperative Anti-tuberculosis Treatment of Spinal Tuberculosis

NCT ID: NCT02477852

Last Updated: 2015-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-12-31

Brief Summary

The purpose of this study is to determine the better preoperative anti-tuberculosis treatment period of patients with spinal tuberculosis.

Detailed Description

Quality assurance plan：All the investigators will receive uniform training. Standard cases follow-up,collection,management systems will be established.The process of cases follow-up,collection,management will be supervised by the third party.Data entry will be in the manner of independent parallel entry.The endpoints events are judged by third party.Statistical analysis are implemented by the statistics institutions of the third party.In order to control the bias,this study takes multicenter,random,control study design.

Sample size assessment:Under the condition of multicenter,random,control design, computational formula takes the rate comparisons of two groups.The key endpoints event is soft tissue width of vertebral side measured by computed tomography. The incidence of the key endpoints event in two weeks group is 30%.The incidence of the key endpoints event in four weeks group is 15%.When alpha value is 0.5 and power value is 0.9,the sample size is 161 patients.If loses visit rate is 20%,the sample size is 194 patients.

Statistical analysis plan:The key events are analyzed by chi-squared test.The statistical significance factors among them are calculated by relative risk.

Data checks and source data verification are supervised by a third-party organization (contract research organization，CRO).

Standard Operating Procedures:Investigator's brochure has explained in detail about the standard operating procedures of everything.Data dictionary can be found in standard operating procedures.

Plan for missing data: The investigators Set a 20% rate of lost to follow-up.

Conditions

Tuberculosis, Spinal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

anti-tuberculosis treatment two weeks

anti-tuberculosis drugs All the patients in the groups receive anti-tuberculosis treatment with Isoniazid 0.3g po qd, Rifampicin 0.45g po qd, Ethambutol 0.75 g po qd,Pyrazinamide 0.5g po tid. for two weeks.

Group Type: EXPERIMENTAL

Isoniazid

Intervention Type: DRUG

preoperative treatment of spinal tuberculosis with Isoniazid

Rifampicin

Intervention Type: DRUG

preoperative treatment of spinal tuberculosis with Rifampicin

Ethambutol

Intervention Type: DRUG

preoperative treatment of spinal tuberculosis with Ethambutol

Pyrazinamide

Intervention Type: DRUG

preoperative treatment of spinal tuberculosis with Pyrazinamide

anti-tuberculosis treatment four weeks

anti-tuberculosis drugs All the patients in the groups receive anti-tuberculosis treatment with Isoniazid 0.3g po qd, Rifampicin 0.45g po qd, Ethambutol 0.75 g po qd,Pyrazinamide 0.5g po tid. for four weeks.

Group Type: EXPERIMENTAL

Isoniazid

Intervention Type: DRUG

preoperative treatment of spinal tuberculosis with Isoniazid

Rifampicin

Intervention Type: DRUG

preoperative treatment of spinal tuberculosis with Rifampicin

Ethambutol

Intervention Type: DRUG

preoperative treatment of spinal tuberculosis with Ethambutol

Pyrazinamide

Intervention Type: DRUG

preoperative treatment of spinal tuberculosis with Pyrazinamide

Interventions

Isoniazid

preoperative treatment of spinal tuberculosis with Isoniazid

Intervention Type: DRUG

Rifampicin

preoperative treatment of spinal tuberculosis with Rifampicin

Intervention Type: DRUG

Ethambutol

preoperative treatment of spinal tuberculosis with Ethambutol

Intervention Type: DRUG

Pyrazinamide

preoperative treatment of spinal tuberculosis with Pyrazinamide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients are diagnosed as spinal tuberculosis clinically,and they do not receive antituberculosis therapy or with 2 weeks.
• The age is between 15 years old and 75 years old.
• Patients have good compliance,and have clear surgical indications.4.Willing to join the research

Exclusion Criteria

• Patients have surgical contraindications.
• Patients have bad habits:taking drug,drinking.3.Patients have mental disease.
• Patients have bad compliance.
• Patients have hematogenous disseminated pulmonary tuberculosis, serious central nervous system tuberculosis,and serious extrapulmonary tuberculosis.
• Patients with drug resistance for Antituberculosis drugs,and patient have to change the treat plan,and patients have immunodeficiency diseases.
• Patients are not diagnosed as spinal tuberculosis clearly.
• Not willing to join the research

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role: collaborator

Beijing Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jing Liu

Administrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

shao fa xu, doctor

Role: STUDY_CHAIR

Beijing Chest Hospital

Locations

Beijing chest hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

shibing qin, doctor

Role: CONTACT

ly13785361227@163.com

86+10+13581557856

shi bi qin, doctor

Role: CONTACT

Facility Contacts

shibing qin, doctor

Role: primary

Other Identifiers

D141107005214002

Identifier Type: -

Identifier Source: org_study_id