Clinical trial NCT02331823: Research on New Regimens for Retreatment Pulmonary Tuberculosis
Official title: New Super-short Course Regimen for Retreatment Pulmonary Tuberculosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Reinfection Pulmonary Tuberculosis
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
Collaborators: name: Shanghai Center for Disease Control and Prevention
name: Jiangsu Province Centers for Disease Control and Prevention
name: Zhejiang University
name: Centers for Disease Control and Prevention
First posted: 2015-01-06
Enrollment: 864
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multi-center, prospective study is performed to investigate the efficacy of new short-course regimen for retreatment pulmonary tuberculosis patients.

To obtain optimized short-course regimen, decrease treatment cost and improve success rate.

Detailed description: China is the country with the second highest Tuberculosis (TB) burden in the world. Most of the retreatment TB patients may develop multi-drug resistant. The resistant rate of any of the anti-TB drug is 35.9%, and the multi-drug resistant rate is 15.4%. Retreatment TB becomes one of the factors which inhibit the decrease of morbidity and mortality of TB. It is also a tuff work in TB control. At present the standardized regimen for retreatment TB is 2SHREZ/6HRE or 3HREZ/6HRE. The drugs in the regimen are all first-line anti-TB drugs which are unsuitable for the high drug resistance prevalence, because the cure rate of this regimen is low and the adverse reaction is severe.

Our study is a national multi-center, prospective trail to investigate the efficacy of a new super-short regimen for retreatment TB patients. The new regimen consists of 5 drugs lasting 5 months. The cure rate and success rate of the new regimen is compared with standardized regimen usually 8-9 months in order to obtain the optimized regimen.

Eligibility criteria: Inclusion Criteria:

* Sputum confirmed diagnosis of retreatment pulmonary tuberculosis
* Must be able to swallow tablets
* Must be able to sign written informed consent form

Exclusion Criteria:

* Extra-pulmonary tuberculosis
* Diabetes
* Allergy to any of the medications in the regimen or pregnancy
* Liver disease
* Renal disease
* Metabolic disease
* Immune system disease
* Hematological disease
* Nervous system and mental disease
* Endocrine disease
* Malignant disease
* Receiving immunosuppressive therapy
* HIV/AIDS
* Alcohol addiction

Primary outcomes:
measure: success rate
timeFrame: for arm A,the point is 5 month after treatment. For arm B,the time point is at the end of the 8 or 9 month's treatment.
Secondary outcomes:
measure: adverse reaction rate
timeFrame: for arm A,the point is 5 month after treatment. For arm B,the time point is at the end of the 8 or 9 month's treatment.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital,China
name: Heping Xiao, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yan L, Kan X, Zhu L, Xu K, Yin J, Jie L, Li Y, Yue J, Cui W, Du J, Wang L, Tan S, Jiang X, Zeng Z, Xu S, Wang L, Chen Y, He W, Gao X, Bai D, Zhao C, Yan X, Zhu Y, Fan Y, Xie L, Deng A, Zhang Q, Xiao H. Short-course Regimen for Subsequent Treatment of Pulmonary Tuberculosis: A Prospective, Randomized, Controlled Multicenter Clinical Trial in China. Clin Ther. 2018 Mar;40(3):440-449. doi: 10.1016/j.clinthera.2018.01.013. Epub 2018 Mar 6.