A Multicentre, EU-wide, Non-Interventional Post-Authorisation Study to Assess the Safety and Usage of Delamanid In Routine Medical Practice in Multidrug-Resistant Tuberculosis Patients.

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other

  Safety study (incl. comparative)
• If ‘other’, further details on the scope of the study:
  The study is a key element to generate data on usage of Deltyba in patients with MDR-TB treated in routine medical practice in order to add to the product safety profile.
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Post-authorisation safety study (PASS)

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J04AK06) delamanid

  delamanid
• Medical condition to be studied:
  Pulmonary tuberculosis

Population studied

• Short description of the study population:
  Patients with pulmonary multidrug-resistant tuberculosis prescribed Deltyba from 6 European countries identified between August 2016 and 30 September 2021.; Inclusion criteria:; • Deltyba must be part of an ACR, ; • for pulmonary multi-drug resistant TB, ; • when an effective treatment regimen could not otherwise be composed for reasons of resistance or tolerability.; ; Exclusion criteria:; • Age < 18 years; • Concomitant use of drugs that were strong inducers of CYP3A4; • Serum albumin < 2.8 g/dL; • Hypersensitivity to the active substance or to any of the excipients
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with pulmonary tuberculosis
• Estimated number of subjects:
  250

Study design details

• Main study objective:
  Primary Objective: To monitor usage of Deltyba in a real-life setting when prescibed as part of an appropriate combination regimen (ACR) designed by the treating physician.
• Outcomes:
  Usage incl. dosage, compliance and treatment duration of Deltyba, 1. AEs (seriuos / non-serious) 2. Treatment outcomes at the end of observation period (cured, treatment completed, failed, lost to follow-up, died, not evaluated, treatment success)
• Data analysis plan:
  No formal hypothesis are to be tested in this study. Data will be summarised by assessment and visit (where applicable) and dsiplayed by enrolled patients. Descriptive summary statistics for continues variables will include the number of patients (N), mean, SD, median and range. Extent of exposure to Deltyba Number of days patients were exposed to Deltyba will be summarized by duration categories using counts and frequencies.