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

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

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

Study Overview

• Status: Unknown
• Conditions: Tuberculosis, Spinal
• Intervention / Treatment: Drug: Isoniazid; Drug: Rifampicin; Drug: Ethambutol; Drug: Pyrazinamide

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: shibing qin, doctor; Phone Number: 86+10+13581557856; Email: ly13785361227@163.com
• Study Contact Backup: Name: shi bi qin, doctor

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 101149
      • Recruiting
      • Beijing Chest Hospital
      • Contact: shibing qin, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Vertebral side width of soft tissue is measured by CT after operation.	up to 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Amount of bone trabecula between bone graft surfaces is measured by X-ray after operation.	up to 6 months

Collaborators and Investigators

• Sponsor: Beijing Chest Hospital
• Collaborators: Beijing Municipal Science & Technology Commission
• Investigators: Study Chair: shao fa xu, doctor, Beijing Chest Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: May 23, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimate): June 23, 2015

Study Record Updates

• Last Update Posted (Estimate): June 23, 2015
• Last Update Submitted That Met QC Criteria: June 22, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: drug; tuberculosis; therapy; spinal; operation; general
• Additional Relevant MeSH Terms: Infections; Musculoskeletal Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Spinal Diseases; Bone Diseases; Mycobacterium Infections; Spondylitis; Bone Diseases, Infectious; Tuberculosis, Osteoarticular; Tuberculosis; Tuberculosis, Spinal; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Anti-Bacterial Agents; Leprostatic Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Fatty Acid Synthesis Inhibitors; Rifampin; Isoniazid; Pyrazinamide; Ethambutol
• Other Study ID Numbers: D141107005214002