Clinical Trial Center
Alessandria, Italy, 15121
NCT Number: NCT06942975
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Alessandria, Italy, 15121
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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).
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
Time frame: Baseline
Number of patients treated at the SC Infectious Diseases who are "cured" as a treatment outcome
Time frame: Baseline
Number of patients treated at the SC Infectious Diseases who are "dead" as a treatment outcome
Time frame: Baseline
Number of patients treated at the SC Infectious Diseases who are "lost to follow-up" as a treatment outcome
Time frame: Baseline
Number of post-treatment relapses
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Other
Evaluation of Tuberculosis Treatment Outcomes Before, During and After COVID-19 in a Dedicated Outpatient Unit
Acronym: CLIO-TB
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.
Published trials that share one or more normalized conditions with this study.
NCT03831906
Actinomycetales Infections, Bacterial Infections
Kampong Cham, Cambodia
View Trial DetailsNCT04826809
Actinomycetales Infections, Bacterial Infections
Mankato, Minnesota, United States
View Trial DetailsNCT05643781
Actinomycetales Infections, Bacterial Infections
Johannesburg, Gauteng, South Africa
View Trial DetailsNCT05220163
Actinomycetales Infections, Bacterial Infections
Cape Town, Western Cape, South Africa
View Trial Details