Evaluation of Tuberculosis Treatment Outcomes (CLIO-TB)

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

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.

Study Overview

• Status: Completed
• Conditions: Tuberculosis
• Intervention / Treatment: Other: Patients with turberculosis

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.

• Study Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• Italy
  • Alessandria, Italy, 15121
    • Clinical Trial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study plans to enroll patients with microbiological confirmation of tuberculosis, notified to the SS Surveillance and Control of Hospital Infections Antimicrobial Stewardship, during the period between 2019 and 2022, taken over by the Infectious Diseases SC of the A.O. SS Antonio e Biagio and Cesare Arrigo of Alessandria, Italy.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of patient characteristics	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	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of cured patients	Number of patients treated at the SC Infectious Diseases who are "cured" as a treatment outcome	Baseline
Number of deceased patients	Number of patients treated at the SC Infectious Diseases who are "dead" as a treatment outcome	Baseline
Number of patients lost to follow-up	Number of patients treated at the SC Infectious Diseases who are "lost to follow-up" as a treatment outcome	Baseline
Number of post-treatment relapses	Number of post-treatment relapses	Baseline

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Actual): November 9, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: April 17, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: COVID-19; Tuberculosis
• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: ASO.MInf.23.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No