NCT02477852

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Beijing Chest Hospital · Academic / Other
• Sex: All
• Age: 15 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Tuberculosis, Spinal

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-06-23
• Last updated: 2015-06-23

Locations

1 site across 1 country: China