Study of Adjunctive Recombinant Human Interleukin-2 Therapy in Patients With MDR-TB
rhIL-2
Study of Adjunctive rhIL-2 Therapy in Patients With MDR-TB That Improves Efficiency and Shortens Course
1 other identifier
interventional
500
1 country
1
Brief Summary
Multidrug-resistant tuberculosis (MDR-TB) has emerged as a challenge worldwide. Few studies have prospectively reported outcomes in patients with pulmonary MDR-TB treated with adjunctive immunotherapy combined to standard chemotherapy. We aimed to assess whether immunotherapy with Interleukin(IL)-2 enhanced the clinical and immune effects of treatment on MDR-TB patients.We performed a multicentre prospective cohort study extend all over Jiangsu province in China. Two groups were generated based on the adjunctive rhIL-2 therapy during 24 months regiman. Bacteriological and imaging data were followed during 24 months with cure rates analysed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 19, 2017
CompletedFirst Posted
Study publicly available on registry
March 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedMarch 3, 2017
September 1, 2009
10 years
February 19, 2017
February 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cure rate
Completion of treatment and at least five consecutive negative sputum cultures from samples collected at least 30 days apart or one positive sputum culture followed by a minimum of three consecutive negative cultures taken at least 30 days apart during the final 12 months of treatment;
130 months
Secondary Outcomes (1)
sputum smear/culture conversion rate
24 months
Study Arms (2)
rhIL-2 Group
EXPERIMENTALThe patients in rhIL-2 Group were given consisted of four courses of low-dose rhIL-2 plus standard anti-tuberculosis chemotherapy. rhIL-2 (500，000U/m)regiman was given subcutaneously (SC) once every other day (q.o.d.) for 30 days and four courses were carried out separately during months 1, 3, 5, and 7. Standard anti-MDR-TB chemotherapy regiman was totally 24 months,including 6-month Z+KM/AM or CM + PAS/(Pa) + PTO +LFX as an intensive phase treatment, followed by an 18-month Z + LFX + PTO + PAS/(Pa) as a consolidation phase treatment.Then all the group patients were followed up for a minimum of 36 months.
Control Group
NO INTERVENTIONThe patients in Control Group were given standard anti-tuberculosis chemotherapy regiman.Standard anti-MDR-TB chemotherapy regiman was totally 24 months,including 6-month Z+KM/AM or CM + PAS/(Pa) + PTO +LFX as an intensive phase treatment, followed by an 18-month Z + LFX + PTO + PAS/(Pa) as a consolidation phase treatment.Then all the group patients were followed up for a minimum of 36 months
Interventions
RhIL-2 treatment intervention was consisted of four courses of low-dose rhIL-2 plus standard anti-tuberculosis chemotharapy. rhIL-2 (500,000 U/m)regimen was given subcutaneously (SC) once every other day (q.o.d.) for 30 days and four courses were carried out separately during months 1, 3, 5, and 7.
Eligibility Criteria
You may qualify if:
- Patients had/were:
- a confirmed case of MDR-TB;
- aged 18-70 years old;
- a chest CT showing visible lung lesions, with or without holes;
- a fasting plasma glucose of less than 7.8 mol/L and a normal fundus examination, if they were diabetic;
- voluntarily joined this study and signed an informed consent form.
You may not qualify if:
- two or more total allergies or any drug or food allergies;
- resistant to some drugs of this program;
- severe disorders of liver, kidney, or hematologic system functions;
- any metabolic diseases, autoimmune diseases, endocrine diseases, cancer, or HIV/AIDS;
- a long-term use of immunosuppressive agents;
- a blood system dysfunction;
- a history of mental illness or epilepsy;
- pregnant or lactating;
- participated in another clinical trial in the last 3 months or were currently participating in other ongoing clinical trials;
- long-term alcohol abuse\>10 years and more than two alcoholic drinks per day);
- any other factor rendering them unsuitable to participate in this project, such as a history of unreliability.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hong Wang, PH.D
the First Affiliated Hospital of Nanjing Medical University, Nanjing, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2017
First Posted
March 3, 2017
Study Start
June 1, 2009
Primary Completion
June 1, 2019
Study Completion
March 1, 2020
Last Updated
March 3, 2017
Record last verified: 2009-09