Evaluation of Tuberculosis Treatment Outcomes

NCT06942975 | Completed

• 1 other identifier: ASO.MInf.23.01
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

Tuberculosis; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of cured patients

  Baseline

• Number of deceased patients

  Baseline

• Number of patients lost to follow-up

  Baseline

• Number of post-treatment relapses

  Baseline

Interventions

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Clinical Trial Center

Alessandria, Italy, 15121, Italy

Location

MeSH Terms

Conditions

Tuberculosis; COVID-19

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 24, 2025
• Study Start: May 8, 2023
• Primary Completion: November 9, 2023
• Study Completion: December 12, 2023
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)