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

NCT02477852 — Phase 4, Unknown, 400 participants, Beijing Chest Hospital

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

Registry	NCT02477852
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	400 (Estimated)
Sponsor	Beijing Chest Hospital (Other); collaborators: Beijing Municipal Science & Technology Commission
Conditions	Tuberculosis, Spinal
Interventions	Isoniazid, Rifampicin, Ethambutol, Pyrazinamide (Drug)
Dates	start 2015-04-01, primary completion 2017-12-01 (estimated), completion 2017-12-01 (estimated), first posted 2015-06-23, last updated 2015-06-23
Locations	1 site in China

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
anti-tuberculosis treatment two weeks	Experimental	Drug: Isoniazid; Drug: Rifampicin; Drug: Ethambutol; Drug: Pyrazinamide	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.
anti-tuberculosis treatment four weeks	Experimental	Drug: Isoniazid; Drug: Rifampicin; Drug: Ethambutol; Drug: Pyrazinamide	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.

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

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

+Eligibility

Sex: All, ages: 15 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
Beijing chest hospital	Beijing, Beijing Municipality	China	Recruiting

+Investigators

shao fa xu, doctor, Study chair, Beijing Chest Hospital