MDR TB Clinical Trial
Official title:
Study of Adjunctive rhIL-2 Therapy in Patients With MDR-TB That Improves Efficiency and Shortens Course
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.
IL-2 therapy regimans are expected to restore the immune response or to change the
immunologic status,thus allowing the host to more efficiently contain and eradicate immune
responses, primarily those against cancers and infectious diseases.To address this, we
performed a prospective randomized controlled multicenter cohort study of 8-month adjunctive
immunotherapy with rhIL-2 for MDR-TB patients compared with the standard chemotherapy.
This multicenter prospective clinical study was conducted at 13 tuberculosis centers
(coordinating hospital specialized in tuberculosis) across Jiangsu province, China. Joined
by the network system of The First Affiliated Hospital of Nanjing Medical University and CDC
of Jiangsu province, participants were enrolled from 2009 to 2018. This study protocol was
approved by the ethics committee of the First Affiliated Hospital of Nanjing Medical
University and was performed adhering to the ethical principles of the Declaration of
Helsinki. All patients provided written informed consent before enrollment. The independent
data and safety of the study were monitored by the hospital monitoring committee.
Patients enrollment
Eligible MDR-TB participants were identified by triplicate-spot sputum smears that were
positive for acid-fast bacilli and a positive sputum culture with resistance to both
isoniazid and rifampin, as determined by susceptibility tests and rapid screening tests .
The results of these assays were confirmed using an L-G medium base modified in the Jiangsu
province Centers for Disease Control and Prevention（CDC）.
Treatment plan for the two cohorts: The patients in rhIL-2 group were given consisted of
four courses of low-dose rhIL-2 (500，000 U/m) given subcutaneously (SC) once every other day
(q.o.d.) for 30 days. Four courses were carried out separately during months 1, 3, 5, and 7.
All enrolled patients with pulmonary MDR-TB received a 24-month standard anti-MDR-TB
chemotherapy regimen: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.
(Z: Pyrazinamide; KM: Kanamycin; AM: Amikacin; CM: Capreomycin; LFX: Levofloxacin; PTO:
Prothionamide; PAS: Para-aminosalicylicacid; Pa:Pasiniazid); After finishing treatment
regimen patients were followed up for a minimum of 36- months or until discontinuation of
regimen, withdrawal of consent, loss to follow-up, death, or end of study.
For all of the participants demographic measurements were recorded on the first clinical
visit. Patient data were collected at enrollment and quarterly intervals. Sputum smear
conversion, sputum culture conversion and chest CT scan improvement were followed up at 3,
6, 12, 18, and 24 months for bacteriological and imaging data collected. Cure rates analysed
and compared in both groups.
The proportions of MDR-TB patients in the two groups achieving sputum smear/culture
conversion, lung lesions absorption were assessed and compared.
Safety assessment included clinical symptom observation, Incidences of adverse event （AE ）in
two groups were assessed and compared. blood routine test, hematologic profile, blood
biochemical examination including hepatic aminotransferase and blood ureantrogen/creatinine,
blood electrolyte test (potassium, magnesium, calcium), serum thyroid stimulating
hormone(TSH), audiology examinations, visual field and color examination.
Cure rate was defined as first outcome. Sputum conversion rate was defined as second
outcome.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02758236 -
Tuberculosis Research of INA-RESPOND On Drug Resistance
|