Tuberculosis, SpinalPhase 4NCT02477852
The Optimal Duration of Preoperative Anti-tuberculosis Treatment of Spinal Tuberculosis
A Phase 4 study testing Isoniazid, Rifampicin and Ethambutol in people with Tuberculosis, Spinal, run by Beijing Chest Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine the better preoperative anti-tuberculosis treatment period of patients with spinal tuberculosis. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Tuberculosis, Spinal
- What is being tested?
- Isoniazid, Rifampicin and Ethambutol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
shi bi qin, doctor contact
China1 site, 1 recruiting
- Recruiting
Beijing chest hospital
Beijing, Beijing Municipality, 101149
shibing qin, doctor
About this study
Official title: 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.
Read the 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
- Being tested
- Isoniazid, Rifampicin, Ethambutol, Pyrazinamide
- Keywords
- tuberculosis, spinal, general, operation, drug, therapy
- Medical subject headings
- Tuberculosis, Spinal, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoniazidDrug
preoperative treatment of spinal tuberculosis with Isoniazid
RifampicinDrug
preoperative treatment of spinal tuberculosis with Rifampicin
EthambutolDrug
preoperative treatment of spinal tuberculosis with Ethambutol
PyrazinamideDrug
preoperative treatment of spinal tuberculosis with Pyrazinamide
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Isoniazid; Drug: Rifampicin; Drug: Ethambutol; Drug: Pyrazinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertebral side width of soft tissue is measured by CT after operation.
Measured: up to 3 months
Secondary outcomes (1)
Amount of bone trabecula between bone graft surfaces is measured by X-ray after operation.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, SpinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Responsible party
- Principal investigator, Jing Liu, Beijing Chest Hospital
- Investigators
- shao fa xu, doctor, Study chair, Beijing Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477852
- Sponsor's protocol ID
- D141107005214002
- Status last verified
- Jun 2015
- First submitted
- 23 May 2015
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Standardized Preoperative Anti-tuberculosis Treatment of Surgical Treatment of Spinal Tuberculosis Patients
- ClinicalTrials.gov ID
- NCT02477852
- Acronym / sponsor ID
- D141107005214002
- Conditions
- Tuberculosis, Spinal
- Keywords
- tuberculosis, spinal, general, operation, drug, therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Beijing Chest HospitalUniversity, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- Apr 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anti-tuberculosis treatment two weeks | Experimental | Drug: Isoniazid, Drug: Rifampicin, Drug: Ethambutol, Drug: Pyrazinamideanti-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: Pyrazinamideanti-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. |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isoniazidpreoperative treatment of spinal tuberculosis with Isoniazid | Drug | anti-tuberculosis treatment four weeks, anti-tuberculosis treatment two weeks |
| Rifampicinpreoperative treatment of spinal tuberculosis with Rifampicin | Drug | anti-tuberculosis treatment four weeks, anti-tuberculosis treatment two weeks |
| Ethambutolpreoperative treatment of spinal tuberculosis with Ethambutol | Drug | anti-tuberculosis treatment four weeks, anti-tuberculosis treatment two weeks |
| Pyrazinamidepreoperative treatment of spinal tuberculosis with Pyrazinamide | Drug | anti-tuberculosis treatment four weeks, anti-tuberculosis treatment two weeks |
Primary outcome
Vertebral side width of soft tissue is measured by CT after operation.
Time frame: up to 3 months
1 secondary outcome
Amount of bone trabecula between bone graft surfaces is measured by X-ray after operation.
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shi bi qin, doctor contact
shao fa xu, doctor study chair
Beijing Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Isoniazid, Rifampicin and Ethambutol in people with Tuberculosis, Spinal, run by Beijing Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shibing qin, doctor (86+10+13581557856, ly13785361227@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertebral side width of soft tissue is measured by CT after operation. (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.