Barriers and enablers of successful TB treatment outcomes in Saxony

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00037154

Enrollment

Registered

2025-10-15

Start date

2025-10-15

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A15 A16 A17 A18 A19

Interventions

Group 1: Study component A: All tuberculosis notifications reported to the State Institute for Health and Veterinary Affairs of Saxony via the relevant local health authorities in accordance with Arti

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: No recruitment will take place for study components A and B. For component C (interviews with stakeholders and affected individuals), the following groups will be recruited using different recruitment approaches: •A total of 4–6 clinicians and allied health professionals •2 representatives from each participating health authority (a total of 6 individuals) •3–4 patients participating health authority (a total of 9–12 individuals)

Exclusion criteria

Exclusion criteria: For each group of participants the following exclusion criteria apply: •Age less than 18 years •Inability to provide informed consent

Design outcomes

Primary

Measure	Time frame
Primary endpoint of the study (study component A) is the final documented outcome of tuberculosis treatment, categorised as a binary outcome based on the standardised classification options included in the notification data: Successful treatment: cure or completion of treatment. No evidence of successful treatment (in short: unsuccessful treatment): treatment discontinuation, treatment failure, continuation of treatment beyond an appropriate time period, unknown treatment outcome without documentation of a transfer of care to another public health authority having occurred. Excluded from the primary analysis: death due to or with tuberculosis before or during treatment, unknown treatment outcome with documentation of a transfer of care to another public health authority having occurred.	—

Measure

Time frame

Primary endpoint of the study (study component A) is the final documented outcome of tuberculosis treatment, categorised as a binary outcome based on the standardised classification options included in the notification data: Successful treatment: cure or completion of treatment. No evidence of successful treatment (in short: unsuccessful treatment): treatment discontinuation, treatment failure, continuation of treatment beyond an appropriate time period, unknown treatment outcome without documentation of a transfer of care to another public health authority having occurred. Excluded from the primary analysis: death due to or with tuberculosis before or during treatment, unknown treatment outcome with documentation of a transfer of care to another public health authority having occurred.

—

Secondary

Measure	Time frame
Secondary endpoints are examined in two separate study components, which are based on different data sources (component B: contextual, non-reportable surveillance case management data in free-text format; component C: interviews with stakeholders and affected individuals): Documented or reported case management structures and operating procedures Documented or reported structural or systemic challenges and gaps in care Documented or reported personal or social barriers to treatment completion among patients Documented or reported examples of existing good practice	—

Measure

Time frame

Secondary endpoints are examined in two separate study components, which are based on different data sources (component B: contextual, non-reportable surveillance case management data in free-text format; component C: interviews with stakeholders and affected individuals): Documented or reported case management structures and operating procedures Documented or reported structural or systemic challenges and gaps in care Documented or reported personal or social barriers to treatment completion among patients Documented or reported examples of existing good practice

—

Countries

Germany

Contacts

Public ContactAnna Kuehne

Professur Öffentliche Gesundheit, Zentrum für Evidenzbasierte Gesundheitsversorgung, (ZEGV) Universitätsklinikum und Medizinische Fakultät Carl Gustav Carus der TU Dresden

anna.kuehne@ukdd.de+49 351 458 649

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026