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

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ClinicalTrials.gov Identifier: NCT02477852
Recruitment Status : Unknown
Verified June 2015 by Jing Liu, Beijing Chest Hospital.
Recruitment status was:  Recruiting
First Posted : June 23, 2015
Last Update Posted : June 23, 2015
Sponsor:
Collaborator:
Beijing Municipal Science & Technology Commission
Information provided by (Responsible Party):
Jing Liu, Beijing Chest Hospital

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

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




Primary Outcome Measures :
  1. Vertebral side width of soft tissue is measured by CT after operation. [ Time Frame: up to 3 months ]

Secondary Outcome Measures :
  1. Amount of bone trabecula between bone graft surfaces is measured by X-ray after operation. [ Time Frame: up to 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477852


Contacts
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Contact: shibing qin, doctor 86+10+13581557856 ly13785361227@163.com
Contact: shi bi qin, doctor

Locations
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China, Beijing
Beijing chest hospital Recruiting
Beijing, Beijing, China, 101149
Contact: shibing qin, doctor         
Sponsors and Collaborators
Beijing Chest Hospital
Beijing Municipal Science & Technology Commission
Investigators
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Study Chair: shao fa xu, doctor Beijing Chest Hospital

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Responsible Party: Jing Liu, Administrator, Beijing Chest Hospital
ClinicalTrials.gov Identifier: NCT02477852     History of Changes
Other Study ID Numbers: D141107005214002
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015
Keywords provided by Jing Liu, Beijing Chest Hospital:
tuberculosis
spinal
general
operation
drug
therapy
Additional relevant MeSH terms:
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Spinal Diseases
Isoniazid
Tuberculosis
Tuberculosis, Spinal
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Tuberculosis, Osteoarticular
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spondylitis
Rifampin
Pyrazinamide
Ethambutol
Antitubercular Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers