Delayed Diagnosis of Bacteriologically Positive Pulmonary Tuberculosis and Relative Optimized Suggestions in China

Fudan University

Status: Completed

Conditions: Tuberculosis; Pulmonary, Confirmed, Unspecified Means

Study type: Observational

Funder types: Other

Identifiers

NCT04434976

KY-2019TB-20

Details and patient eligibility

About

The purpose of the study is to collect health-seeking pathways, sociodemographic characteristics and symptoms of 400 newly diagnosed patients with bacteriologically confirmed pulmonary tuberculosis(TB).

Full description

This research is a retrospective, multicenter, case-control study. The purpose of this study is to collect and assess health-seeking pathways, sociodemographic characteristics and symptoms of 400 newly diagnosed patients with bacteriologically confirmed pulmonary tuberculosis(TB).

According to inclusion criteria and exclusion criteria, a total of 400 participants with bacteriologically confirmed TB will be recruited and acquired their health-seeking pathways in different clinical institutions of pulmonary tuberculosis. Totally, 20 TB-designated medical institutions will be conducted in depth, covering the eastern region (7), the central region (8) and the western region (5), each hospital will enroll 20 eligible patients on the basis of convenience.

The cohorts are divided into delayed diagnosis and undelayed diagnosis. The former is defined if The length from the first clinical visit date to the diagnosis confirmed date is more than 14 days. Diagnosis is confirmed by any positive result of anti fast bacteria smear, culture, histological test, and molecular detection such as GeneXpert. By offline or online interview, we aim to collect basic sociodemographic characteristics, symptoms, health-seeking pathway, including: hospital name, the date of each visit, laboratory tests and radiology evaluation results, diagnosis, treatment, medical and transportation costs. Then list the hospitals of previous consultations and trace their classification through the official website of the Health and Medical Commission. Determine whether these hospital are designated institution based on the CDC's publicity. Consult the laboratory facilities by phone.

The primary objective is to gain the median time of pulmonary tuberculosis diagnosis confirmed and the correlation between the classification of the first-visit-institution and the diagnosis delay of the pulmonary tuberculosis.

The secondary objective is to gain the bacteriology examination coverage rate: anti fast bacteria smear, tuberculosis culture, and GeneXpert; the correlation between the use of fluoroquinolones as anti-infection treatment before tuberculosis diagnosis confirmed and the diagnosis delay of the pulmonary tuberculosis; the sociodemographic characteristics of patients with or without pulmonary tuberculosis diagnosis delay; The rates of onset symptoms and its correlation to diagnosis delayed of pulmonary tuberculosis diagnosis confirmed patients.

Enrollment: 400 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Bacteriological positive: including positive AFB smear/ culture / molecular test;
• Agree to accept this survey;

Exclusion criteria

• HIV antibody positive and AIDS patients;
• Combined with extrapulmonary TB;
• Critically ill patients, and according to the judgment of the research physician, it is impossible to survive for more than 16 weeks;

Trial design

400 participants in 2 patient groups

delayed diagnosis

Description:

The length from the first clinical visit date to the diagnosis confirmed date is more than 14 days. Diagnosis is confirmed by any positive result of anti fast bacteria smear, culture, histological test, and molecular detection such as GeneXpert.

undelayed diagnosis

Description:

The length from the first clinical visit date to the diagnosis confirmed date is equal or less than 14 days. Diagnosis is confirmed by any positive result of anti fast bacteria smear, culture, histological test, and molecular detection such as GeneXpert.