Tokyo, May 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061743) titled 'A real-world study on gradually increasing the dose (incremental reintroduction and desensitization) after side effects from anti-tuberculosis drugs' on May 29.

Study Type: Observational

Primary Sponsor: Institute - NHO Tokyo National Hospital

Condition: Condition - Tuberculosis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To clarify the real-world practice of planned low-dose incremental reintroduction (low-dose incremental reintroduction and desensitization therapy) after the onset of adverse reactions to anti-tuberculosis drugs, using electronic medical record data from NHO Tokyo National Hospital and large-scale medical receipt databases. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Single-center data: Patients aged 18 years or older who visited our hospital between April 1, 2014, and March 31, 2026, with a first-time definitive diagnosis of ICD-10 codes A15-A19, and a history of same-day prescription of 3 or more groups among first-line anti-tuberculosis drugs (INH, RFP/RBT, PZA, EMB/SM). 2) JMDC and DeSC databases: Patients aged 18 years or older with a first-time definitive diagnosis of ICD-10 codes A15-A19, and a history of same-day prescription of 3 or more groups among first-line anti-tuberculosis drugs. Key exclusion criteria - 1) Patients for whom anti-tuberculosis drugs were used for purposes other than active tuberculosis treatment (e.g., non-tuberculous mycobacterial infection, latent tuberculosis infection, prophylactic use). 2) Patients for whom the purpose of anti-tuberculosis drug administration is indeterminate. 3) Patients whose minimum necessary medical records are missing, making it extremely difficult to evaluate the implementation of low-dose incremental reintroduction or desensitization therapy (for single-center data). 4) Patients who refuse to participate in the study. Target Size - 700

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 26 Day Date of IRB - 2026 Year 05 Month 26 Day Anticipated trial start date - 2026 Year 05 Month 29 Day Last follow-up date - 2029 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070659

Disclaimer: Curated by HT Syndication.