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Evaluation of Tuberculosis Treatment Outcomes

Evaluation of Tuberculosis Treatment Outcomes Before, During and After COVID-19 in a Dedicated Outpatient Unit

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06942975
Acronym
CLIO-TB
Enrollment
111
Registered
2025-04-24
Start date
2023-05-08
Completion date
2023-12-12
Last updated
2025-04-24

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

Conditions

Tuberculosis

Keywords

Tuberculosis, COVID-19

Brief summary

Tuberculosis (TB) is an infectious disease caused by Mycobacterium species grouped in the Mycobacterium tuberculosis complex. TB remains a major global health problem, despite the fact that there are drugs that can eradicate the infection. The study aims to describe the clinical, microbiological, therapeutic and prognostic characteristics of TB patients afferent to the SC Infectious Diseases of A.O. SS Antonio e Biagio e Cesare Arrigo of Alexandria during 2019-2022 and, secondarily, to evaluate the treatment outcomes (as defined by the World Health Organization) of TB patients afferent to the SC Infectious Diseases of A. O. SS Antonio e Biagio e Cesare Arrigo of Alexandria considering the influence of the SARS-CoV-2 pandemic (pre-pandemic, inter-pandemic and post-pandemic period) and to evaluate the post-treatment relapse rate.

Detailed description

Tuberculosis (TB) is an infectious disease caused by Mycobacterium species grouped in the Mycobacterium tuberculosis complex. TB remains a major global health problem, despite the fact that there are drugs that can eradicate the infection. Of concern, however, are both underdiagnosis and the circulation of strains resistant to first-line therapies. Indeed, if not properly administered, TB treatment regimens are associated with unfavorable outcomes, promoting the circulation of the bacterium and the emergence of drug resistance. Monitoring the effectiveness of tuberculosis treatment is therefore of paramount importance in both clinical practice and surveillance to maximize the quality of individual patient care and the effectiveness of public health actions. The COVID-19 pandemic has created unprecedented challenges for populations, public health departments, and health facilities worldwide, and is likely to have devastating effects on global TB prevention and control programs, including a reversal of the progress achieved over the past decade.The present study aims to describe the case history of TB patients afferent to A.O. SS Antonio e Biagio and Cesare Arrigo in Alexandria and to evaluate treatment outcomes. This facility underwent a disruption of services during the pandemic period, and also initiated in the post-pandemic period a TB clinical management service with an active retention-in-care approach, generating appointments for follow-up visits and contacting patients who did not keep these appointments.

Interventions

OTHERPatients with turberculosis

The study plans to collect data from patients with microbiological confirmation of tuberculosis, notified to the SS Hospital Infection Surveillance and Control Antimicrobial Stewardship, in the period between 2019 and 2023, taken in charge by the SC Infectious Diseases of the A.O. SS Antonio e Biagio and Cesare Arrigo of Alessandria (Piedmont Region, Italy).

Sponsors

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients aged ≥18 years * Patients with tuberculosis with microbiological confirmation * Patients notified to the SS Surveillance and Control Hospital Infections Antimicrobial Stewardship of the Alexandria Hospital Company from 2019 to 2023 * Patients taken in charge by the SC Infectious Diseases of the Alexandria Hospital Company for whom MOD B has been completed * Obtaining informed consent

Design outcomes

Primary

MeasureTime frameDescription
Description of patient characteristicsBaselineDescription of the characteristics of TB patients referred to the SC Infectious Diseases of the A.O. SS Antonio e Biagio and Cesare Arrigo of Alexandria in the period 2019-2023

Secondary

MeasureTime frameDescription
Number of cured patientsBaselineNumber of patients treated at the SC Infectious Diseases who are cured as a treatment outcome
Number of deceased patientsBaselineNumber of patients treated at the SC Infectious Diseases who are dead as a treatment outcome
Number of patients lost to follow-upBaselineNumber of patients treated at the SC Infectious Diseases who are lost to follow-up as a treatment outcome
Number of post-treatment relapsesBaselineNumber of post-treatment relapses

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026