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

NCT02477852 | Unknown Phase 4

• 1 other identifier: D141107005214002
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tuberculosis, Spinal

Keywords

tuberculosis; spinal; general; operation; drug; therapy

Outcome Measures

Primary Outcomes (1)

• Vertebral side width of soft tissue is measured by CT after operation.

  up to 3 months

Secondary Outcomes (1)

• Amount of bone trabecula between bone graft surfaces is measured by X-ray after operation.

  up to 6 months

Study Arms (2)

anti-tuberculosis treatment two weeks

EXPERIMENTAL

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; Drug: Rifampicin; Drug: Ethambutol; Drug: Pyrazinamide

anti-tuberculosis treatment four weeks

EXPERIMENTAL

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; Drug: Rifampicin; Drug: Ethambutol; Drug: Pyrazinamide

Interventions

Isoniazid DRUG

preoperative treatment of spinal tuberculosis with Isoniazid

anti-tuberculosis treatment four weeks; anti-tuberculosis treatment two weeks

Rifampicin DRUG

preoperative treatment of spinal tuberculosis with Rifampicin

anti-tuberculosis treatment four weeks; anti-tuberculosis treatment two weeks

Ethambutol DRUG

preoperative treatment of spinal tuberculosis with Ethambutol

anti-tuberculosis treatment four weeks; anti-tuberculosis treatment two weeks

Pyrazinamide DRUG

preoperative treatment of spinal tuberculosis with Pyrazinamide

anti-tuberculosis treatment four weeks; anti-tuberculosis treatment two weeks

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Chest Hospital: lead
• Beijing Municipal Science & Technology Commission: collaborator

Study Sites (1)

Beijing chest hospital

Beijing, Beijing Municipality, 101149, China

RECRUITING

MeSH Terms

Conditions

Tuberculosis, Spinal; Tuberculosis

Interventions

Isoniazid; Rifampin; Ethambutol; Pyrazinamide

Condition Hierarchy (Ancestors)

Tuberculosis, Osteoarticular; Tuberculosis, Extrapulmonary; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Bone Diseases, Infectious; Bone Diseases; Musculoskeletal Diseases; Spondylitis; Spinal Diseases

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Ethylenediamines; Diamines; Polyamines; Amines; Pyrazines

Study Officials

• shao fa xu, doctor

  Beijing Chest Hospital

  STUDY CHAIR

Central Study Contacts

shibing qin, doctor

CONTACT

86+10+13581557856; ly13785361227@163.com

shi bi qin, doctor

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Administrator

Study Record Dates

• First Submitted: May 23, 2015
• First Posted: June 23, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

CN (1)