Clinical trial NCT04766307: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Tuberculosis, Pulmonary
Keywords: pulmonary tuberculosis
interleukin-2
clinical trial
Lead sponsor: Beijing Chest Hospital
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 1100
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: 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: 1. Design:The study is a multi-center, randomized, controlled, open clinical trial.
2. Population:Initial smear positive pulmonary tuberculosis patients who fulfill the inclusion and exclusion criteria.
3. 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).
4. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary study endpoint was the proportion of subjects who had converted their sputum cultures to negative at the end of treatment.
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Fuyang
country: China
facility: the Second hospital of Fuyang
state: Anhui
city: Fuzhou
country: China
facility: Fuzhou Chest Hospital
state: Fujian
city: Shenzhen
country: China
facility: Shenzhen third people's Hospital
state: Guangzhou
city: Guiyang
country: China
facility: Guiyang Public Health Treatment Center
state: Guizhou
city: Handan
country: China
facility: The Infectious Hospital of Handan
state: Hebei
city: Shijiazhuang
country: China
facility: Hebei Chest Hospital
state: Hebei
city: Jiamusi
country: China
facility: Jiamusi Insititute For Tuberculosis Control
state: Heilongjiang
city: Mudanjiang
country: China
facility: The Infectious Hospital of mudanjiang
state: Heilongjiang
city: Zhengzhou
country: China
facility: Zhengzhou Sixth People's Hospital
state: Henan
city: Changsha
country: China
facility: the central hospital of Changsha
state: Hunan
city: Nanjing
country: China
facility: the people's hospital of Jiangsu province
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Chest Hospital
state: Jiangxi
city: Dalian
country: China
facility: Dalian Tuberculosis Hospital
state: Liaoning
city: Qingdao
country: China
facility: Qingdao Chest Hospital
state: Shandong
city: Taiyuan
country: China
facility: Taiyuan Fourth People's Hospital
state: Shanxi
city: Xi'an
country: China
facility: Xian Chest Hospital
state: Shanxi
Study officials:
affiliation: Beijing Chest Hospital
name: Naihui Chu, PhD
role: PRINCIPAL_INVESTIGATOR
References: