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A New Treatment for Primary Smear-positive Pulmonary Tuberculosis With Interleukin-2

Primary Purpose

Tuberculosis, Pulmonary

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Interleukin-2
Sponsored by
Beijing Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tuberculosis, Pulmonary focused on measuring pulmonary tuberculosis, interleukin-2, clinical trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Is willing and able to give informed consent to participate in the trial treatment and follow-up (signed or witnessed consent if the patient is illiterate).
  2. Is aged 18-65 years.
  3. Chest X-ray showed that there were active tuberculosis foci in the lungs with one of the following cases: (1) sputum specimens (or sputum and bronchial lavage fluid) were 2+ once or 1+ twice ; (2) sputum smear positive and sputum X-pert positive.
  4. Newly diagnosed cases receiving anti-TB treatment for less than one month.
  5. No other immune preparations （such as: thymosin，IFN-y，BCG-PSN，Mycobacterium vaccae，Utilins，lentinan ）were used in the past 3 months.
  6. the urine analysis of Women of childbearing age are negative and agree to use the efficient contraception during the study period.

Exclusion Criteria:

  1. Has a known allergy to any drug of treatment regimens.
  2. There are serious complications or impaired renal function (serum creatinine is 1.5 times higher than the normal limit) or impaired liver function (ALT or AST levels are 3 times higher than the normal limit); hemoglobin is less than 7.0g/dl. Platelets less than 50x109/L.
  3. Complication with Diabetic.
  4. The screening diagnosis was isoniazid resistance or rifampin resistance
  5. There are serious cardiovascular diseases, such as heart failure, hypertension, arrhythmia or post myocardial infarction state.
  6. Is known to be pregnant or breast-feeding.
  7. Karnofsky score is less than 50%.
  8. Is taking any clinical trial in the past 3 months.
  9. Is critically ill, and in the judgment of the investigator, not fit for the study or unlikely to complete the full course of study.
  10. HIV is positive or AIDS patients.
  11. Has Non tuberculous mycobacterial lung disease.
  12. Merge with extra pulmonary tuberculosis.

Sites / Locations

  • the Second hospital of FuyangRecruiting
  • Fuzhou Chest HospitalRecruiting
  • Shenzhen third people's HospitalRecruiting
  • Guiyang Public Health Treatment CenterRecruiting
  • The Infectious Hospital of HandanRecruiting
  • Hebei Chest HospitalRecruiting
  • Jiamusi Insititute For Tuberculosis ControlRecruiting
  • The Infectious Hospital of mudanjiangRecruiting
  • Zhengzhou Sixth People's HospitalRecruiting
  • the central hospital of ChangshaRecruiting
  • the people's hospital of Jiangsu provinceRecruiting
  • Jiangxi Chest HospitalRecruiting
  • Dalian Tuberculosis HospitalRecruiting
  • Qingdao Chest HospitalRecruiting
  • Taiyuan Fourth People's HospitalRecruiting
  • Xian Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

Control regimen group

Arm Description

Experimental group regimen:2H(Isoniazid)R(Rifampicin)Z(Pyrazinamide)E(Ethambutol)/4HR+Interleukin-2 （500000 units daily, subcutaneous injection in the first month） Dosage: isoniazid 300mg(given once daily),rifampin 450mg(less than 50kg,given once daily) or 600mg(more than 50kg,given once daily),pyrazinamide 1500mg(less than 50kg,given once daily) or 30mg/kg(more than 50kg,given once daily),ethambutol 750mg(less than 50kg,given once daily) or 1000mg(more than 50kg,given once daily).

The control group regimen: 2H(Isoniazid)R(Rifampicin)Z(Pyrazinamide)E(Ethambutol)/4HR Dosage: isoniazid 300mg(given once daily),rifampin 450mg(less than 50kg,given once daily) or 600mg(more than 50kg,given once daily),pyrazinamide 1500mg(less than 50kg,given once daily) or 30mg/kg(more than 50kg,given once daily),ethambutol 750mg(less than 50kg,given once daily) or 1000mg(more than 50kg,given once daily).

Outcomes

Primary Outcome Measures

The primary study endpoint was the proportion of subjects who had converted their sputum cultures to negative at the end of treatment.
A cure was defined as who was smear- or culture-negative in the last month of treatment and on at least one previous occasion. Treatment completion was defined as patients who completed treatment but who does not have a negative sputum smear or culture result in the last month of treatment and on at least one previous occasion. Treatment failure was defined as patients whose sputum smear or culture is positive at 5 months or later during treatment.

Secondary Outcome Measures

Full Information

First Posted
December 20, 2017
Last Updated
February 20, 2021
Sponsor
Beijing Chest Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04766307
Brief Title
A New Treatment for Primary Smear-positive Pulmonary Tuberculosis With Interleukin-2
Official Title
A Randomized Multicenter Clinical Trial of a New Treatment for Primary Smear- Positive Pulmonary Tuberculosis With Interleukin-2
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 20, 2016 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chest Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to compare the efficacy and safety of standard chemotherapy regimen 2HRZE/4HR plus IL-2 and standard regimen 2HRZE/4HR for newly diagnosed smear positive pulmonary tuberculosis.
Detailed Description
Design:The study is a multi-center, randomized, controlled, open clinical trial. Population:Initial smear positive pulmonary tuberculosis patients who fulfill the inclusion and exclusion criteria. Investigational regimens: Experimental group regimen:2HRZE/4HR+Interleukin-2 （500000 units daily, subcutaneous injection in the first month） The control group regimen: 2HRZE/4HR Dosage: isoniazid 300mg(given once daily),rifampin 450mg(less than 50kg,given once daily) or 600mg(more than 50kg,given once daily),pyrazinamide 1500mg(less than 50kg,given once daily) or 30mg/kg(more than 50kg,given once daily),ethambutol 750mg(less than 50kg,given once daily) or 1000mg(more than 50kg,given once daily). Primary and Secondary outcome measures: primary efficacy outcome measures:(a)Negative conversion rate of sputum bacteria. (b)Sputum smear conversion proportion at the treatment completion . secondary efficacy outcome measure:Recurrence rate after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Pulmonary
Keywords
pulmonary tuberculosis, interleukin-2, clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
Experimental group regimen:2H(Isoniazid)R(Rifampicin)Z(Pyrazinamide)E(Ethambutol)/4HR+Interleukin-2 （500000 units daily, subcutaneous injection in the first month） Dosage: isoniazid 300mg(given once daily),rifampin 450mg(less than 50kg,given once daily) or 600mg(more than 50kg,given once daily),pyrazinamide 1500mg(less than 50kg,given once daily) or 30mg/kg(more than 50kg,given once daily),ethambutol 750mg(less than 50kg,given once daily) or 1000mg(more than 50kg,given once daily).
Arm Title
Control regimen group
Arm Type
Active Comparator
Arm Description
The control group regimen: 2H(Isoniazid)R(Rifampicin)Z(Pyrazinamide)E(Ethambutol)/4HR Dosage: isoniazid 300mg(given once daily),rifampin 450mg(less than 50kg,given once daily) or 600mg(more than 50kg,given once daily),pyrazinamide 1500mg(less than 50kg,given once daily) or 30mg/kg(more than 50kg,given once daily),ethambutol 750mg(less than 50kg,given once daily) or 1000mg(more than 50kg,given once daily).
Intervention Type
Drug
Intervention Name(s)
Interleukin-2
Other Intervention Name(s)
IL-2
Intervention Description
Interleukin 2 (IL-2) is a pleiotropic cytokine that is produced after antigen activation and plays crucial roles in the immune response. IL-2 secreted by activated T cells is central to the development of an immune response to infection, promoting the differentiation and proliferation of lymphoid cells. This hydrophobic molecule and the various cytokines that it elicits regulates the behavior of T and B lymphocytes, monocytes/macrophages, natural killer (NK) cells, and neutrophils. IL-2 therapy regimens are expected to limit mycobacterial replication. Early clinical trials with IL-2 demonstrated that IL-2 immunotherapy may be useful in controlling infectious disease.
Primary Outcome Measure Information:
Title
The primary study endpoint was the proportion of subjects who had converted their sputum cultures to negative at the end of treatment.
Description
A cure was defined as who was smear- or culture-negative in the last month of treatment and on at least one previous occasion. Treatment completion was defined as patients who completed treatment but who does not have a negative sputum smear or culture result in the last month of treatment and on at least one previous occasion. Treatment failure was defined as patients whose sputum smear or culture is positive at 5 months or later during treatment.
Time Frame
two-month course intensive phase treatment, followed by a four-month consolidation phase treatment.Some TB patients with cavity should receive 9 total months (7 months of continuation therapy after the initial 2-month intensive phase).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is willing and able to give informed consent to participate in the trial treatment and follow-up (signed or witnessed consent if the patient is illiterate). Is aged 18-65 years. Chest X-ray showed that there were active tuberculosis foci in the lungs with one of the following cases: (1) sputum specimens (or sputum and bronchial lavage fluid) were 2+ once or 1+ twice ; (2) sputum smear positive and sputum X-pert positive. Newly diagnosed cases receiving anti-TB treatment for less than one month. No other immune preparations （such as: thymosin，IFN-y，BCG-PSN，Mycobacterium vaccae，Utilins，lentinan ）were used in the past 3 months. the urine analysis of Women of childbearing age are negative and agree to use the efficient contraception during the study period. Exclusion Criteria: Has a known allergy to any drug of treatment regimens. There are serious complications or impaired renal function (serum creatinine is 1.5 times higher than the normal limit) or impaired liver function (ALT or AST levels are 3 times higher than the normal limit); hemoglobin is less than 7.0g/dl. Platelets less than 50x109/L. Complication with Diabetic. The screening diagnosis was isoniazid resistance or rifampin resistance There are serious cardiovascular diseases, such as heart failure, hypertension, arrhythmia or post myocardial infarction state. Is known to be pregnant or breast-feeding. Karnofsky score is less than 50%. Is taking any clinical trial in the past 3 months. Is critically ill, and in the judgment of the investigator, not fit for the study or unlikely to complete the full course of study. HIV is positive or AIDS patients. Has Non tuberculous mycobacterial lung disease. Merge with extra pulmonary tuberculosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naihui Chu, PhD
Email
dongchu1994@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naihui Chu, PhD
Organizational Affiliation
Beijing Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Second hospital of Fuyang
City
Fuyang
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
haiqing Liu
Phone
13855894607
Facility Name
Fuzhou Chest Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaohong Chen
Phone
13275013012
Facility Name
Shenzhen third people's Hospital
City
Shenzhen
State/Province
Guangzhou
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qunyi Deng
Phone
13823145706
Facility Name
Guiyang Public Health Treatment Center
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jing Chen
Phone
13985410691
Facility Name
The Infectious Hospital of Handan
City
Handan
State/Province
Hebei
ZIP/Postal Code
056000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chunyan Zhang
Phone
15803200615
Facility Name
Hebei Chest Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhihui Li
Phone
13833465658
Email
lzhihui2011@126.com
Facility Name
Jiamusi Insititute For Tuberculosis Control
City
Jiamusi
State/Province
Heilongjiang
ZIP/Postal Code
154000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chao Qiu
Phone
13039651567
Facility Name
The Infectious Hospital of mudanjiang
City
Mudanjiang
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lixiang Chu
Phone
18645753107
Facility Name
Zhengzhou Sixth People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yu Chen
Phone
13823145706
Facility Name
the central hospital of Changsha
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chunxiang Li
Phone
13055161267
Facility Name
the people's hospital of Jiangsu province
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hong Wang
Facility Name
Jiangxi Chest Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
aihua Deng
Phone
13307096301
Facility Name
Dalian Tuberculosis Hospital
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qing Ji
Phone
13009482267
Facility Name
Qingdao Chest Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yufeng Liu
Phone
13863985511
Facility Name
Taiyuan Fourth People's Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
quanhong Wang
Phone
13934242762
Facility Name
Xian Chest Hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
liyun Dang
Phone
18091888085

12. IPD Sharing Statement

Learn more about this trial

A New Treatment for Primary Smear-positive Pulmonary Tuberculosis With Interleukin-2

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