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

Tuberculosis, Spinal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02477852
• Other study ID #: D141107005214002
• Status: Recruiting
• Phase: Phase 4
• First received: May 23, 2015
• Last updated: June 22, 2015
• Start date: April 2015
• Est. completion date: December 2017

Study information

• Verified date: June 2015
• Source: Beijing Chest Hospital
• Contact: shibing qin, doctor
• Phone: 86+10+13581557856
• Email: ly13785361227[@]163.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Spinal

Intervention

Drug:
• Isoniazid
preoperative treatment of spinal tuberculosis with Isoniazid
• Rifampicin
preoperative treatment of spinal tuberculosis with Rifampicin
• Ethambutol
preoperative treatment of spinal tuberculosis with Ethambutol
• Pyrazinamide
preoperative treatment of spinal tuberculosis with Pyrazinamide

Locations

Country	Name	City	State
China	Beijing chest hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Chest Hospital	Beijing Municipal Science & Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vertebral side width of soft tissue is measured by CT after operation.		up to 3 months	Yes
Secondary	Amount of bone trabecula between bone graft surfaces is measured by X-ray after operation.		up to 6 months	Yes