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Completed

NCT Number: NCT06942975

Evaluation of Tuberculosis Treatment Outcomes

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patients with turberculosis

Other

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).

Primary outcomes

  1. Description of patient characteristics

    Time frame: Baseline

    Description 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 outcomes

  1. Number of cured patients

    Time frame: Baseline

    Number of patients treated at the SC Infectious Diseases who are "cured" as a treatment outcome

  2. Number of deceased patients

    Time frame: Baseline

    Number of patients treated at the SC Infectious Diseases who are "dead" as a treatment outcome

  3. Number of patients lost to follow-up

    Time frame: Baseline

    Number of patients treated at the SC Infectious Diseases who are "lost to follow-up" as a treatment outcome

  4. Number of post-treatment relapses

    Time frame: Baseline

    Number of post-treatment relapses

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: CLIO-TB

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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