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

Sponsor

Beijing Chest Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02477852

Collaborator

Beijing Municipal Science & Technology Commission (Other)

400

Enrollment

Location

Arms

Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis, Spinal	Drug: Isoniazid Drug: Rifampicin Drug: Ethambutol Drug: Pyrazinamide	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Study of Standardized Preoperative Anti-tuberculosis Treatment of Surgical Treatment of Spinal Tuberculosis Patients

Study Start Date :

Apr 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Isoniazid preoperative treatment of spinal tuberculosis with Isoniazid Drug: Rifampicin preoperative treatment of spinal tuberculosis with Rifampicin Drug: Ethambutol preoperative treatment of spinal tuberculosis with Ethambutol Drug: Pyrazinamide preoperative treatment of spinal tuberculosis with Pyrazinamide
Experimental: 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.	Drug: Isoniazid preoperative treatment of spinal tuberculosis with Isoniazid Drug: Rifampicin preoperative treatment of spinal tuberculosis with Rifampicin Drug: Ethambutol preoperative treatment of spinal tuberculosis with Ethambutol Drug: Pyrazinamide preoperative treatment of spinal tuberculosis with Pyrazinamide

Arm

Intervention/Treatment

Experimental: 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.

Drug: Isoniazid

preoperative treatment of spinal tuberculosis with Isoniazid

Drug: Rifampicin

preoperative treatment of spinal tuberculosis with Rifampicin

Drug: Ethambutol

preoperative treatment of spinal tuberculosis with Ethambutol

Drug: Pyrazinamide

preoperative treatment of spinal tuberculosis with Pyrazinamide

Experimental: anti-tuberculosis treatment four weeks

Drug: Isoniazid

preoperative treatment of spinal tuberculosis with Isoniazid

Drug: Rifampicin

preoperative treatment of spinal tuberculosis with Rifampicin

Drug: Ethambutol

preoperative treatment of spinal tuberculosis with Ethambutol

Drug: Pyrazinamide

preoperative treatment of spinal tuberculosis with Pyrazinamide

Outcome Measures

Primary Outcome Measures

Vertebral side width of soft tissue is measured by CT after operation. [up to 3 months]

Secondary Outcome Measures

Amount of bone trabecula between bone graft surfaces is measured by X-ray after operation. [up to 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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