Tuberculosis
Conditions
Keywords
infectious diseases, tuberculosis, clinical, social sciences, public health, Comorbidities, epidemiology, Treatment and care, Transmission, France, biobank, mycobacterial collection, cohort, prospective
Brief summary
The French Tuberculosis Cohort is a prospective, national, multicenter, low-intervention study including subjects aged 18 years and older with tuberculosis disease for which inpatient treatment is initiated. The goal of this observational study is to follow-up and anti-tuberculosis treatment will be provided according to current French recommendations. Participants will provide sociodemographic, clinical, biological, radiological and bacteriological data at various protocol visits at 2 days, 1 and 2 weeks, 2 months, at the end of treatment, 12 and 24 months. Consenting participants will have samples collected at scheduled visits for the establishment of a biobank. This will include blood, urine, breath and hair samples. The positive mycobacterial strains will constitute a specimen bank.
Detailed description
Main objectif: To describe the sociodemographic, clinical, radiologic, and bacteriologic characteristics, as well as comorbidities and their impact on treatment outcomes and relapse rate up to 24 months after the start of anti-tuberculosis treatment in people with tuberculosis disease diagnosed in France. Secondary objectives: * Evaluate the effects of immunosuppression (HIV infection, organ transplantation, immunosuppressive treatments) on tuberculosis symptomatology, complications (including immune reconstitution inflammatory syndromes (IRIS), and drug interactions), treatment response and survival. * Describe the characteristics of severe (meningeal, pericardial, miliary, etc.) or complicated forms of tuberculosis, including resistant tuberculosis, their management (treatment of resistant TB, use of anti-TNF, corticoids), their impact on treatment outcomes, relapse rates up to 24 months, sequelae and survival. * Describe representations of the disease and its care, its impact on quality of life, and the effect of social determinants, situations of precariousness, health literacy, belonging to key populations (incarcerated, migrant and/or homeless people) as well as mental health disorders and addictions on compliance, experience of the disease, follow-up, and treatment outcomes. * Describe the effect of new short-course tuberculosis treatments on adherence, disease experience, follow-up and treatment outcomes. * Describe post-tuberculosis pulmonary sequelae, study their association with immunosuppression, pharmacological dosages, other comorbidities, tobacco and alcohol consumption, and measure physiological, structural and functional disorders, their impact on quality of life and survival. * Study the potential diagnostic and prognostic value of new biomarkers in people with tuberculosis and the effect of exposure to anti-tuberculosis treatment on response to tuberculosis therapy.
Interventions
None listed
Sponsors
ANRS, Emerging Infectious Diseases
University of Bordeaux
Amiens University Hospital
Centre National de la Recherche Scientifique, France
Saint Antoine University Hospital
University of Lyon
Claude Bernard University
University Hospital, Bordeaux
Saint-Louis Hospital, Paris, France
Centre Hospitalier Universitaire, Amiens
Hôpital Jean Verdier
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Aged ≥18 years. * Diagnosis of tuberculosis by microbiological or clinical means, including on the basis of a pathological examination for extrapulmonary tuberculosis leading to a Compulsory Declaration (CD) and treated for less than 8 days. * Have signed a voluntary, informed and written consent (at the latest on the day of inclusion and before any examination carried out as part of the research), or alternatively, consent from relatives in cases of tuberculous meningitis or other serious forms of tuberculosis with impaired consciousness or confusion, until the person is able to give their consent.
Exclusion criteria
* Presence of significant cognitive impairment that, in the opinion of the site investigator or designated person, may affect the ability to give reliable informed consent (except in the specific case of meningeal tuberculosis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with successful anti-tuberculosis treatment outcome, defined as definite or probable cure, by Month 12 | through treatment completion; Month 12 | Definite cure (microbiological): negative cultures (or direct examination) of respiratory specimens on two occasions during follow-up, in the last month of treatment and on an intermediate specimen, in a participant who has completed treatment and has never met the definition of treatment failure. |
| Success of the anti-tuberculosis treatment | through treatment completion; Month 12 | Probable cure: clinical and radiological improvement of tuberculosis-related symptoms in a participant who has completed treatment and never met the definition of treatment failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early microbiological response | Month 2 | Assessed by the conversion (negativation) of cultures specimens on two occasions during follow-up, in the last month of treatment and on an intermediate specimen, in a participant who has completed treatment and has never met the definition of treatment failure. |
| Positive culture | Month 5 | Number of Positive culture after 5 months of treatment |
| Tuberculosis-related death | Month 5 | Number of deaths directly related to tuberculosis in the year following diagnosis |
| Premature treatment interruption without resumption | Month 5 | Number of interrupted treatments before the end of the planned duration and not resumed (for a reason other than a rejected tuberculosis diagnosis |
| Ongoing treatment at Month 12 due to interruption, resistance, adverse events, or initial failure | Month 12 | Number of treatment ongoing at 12 months because interrupted for more than two months or modified for resistance, side effects/intolerance, initial failure |
| Transfer or loss to follow-up | Month 5 | Number of transfers or loss of follow-up |
| All-cause mortality | Until Month 24 | Occurrence and causes of death after tuberculosis diagnosis after inclusion and causes |
| Tuberculosis relapse | Between end of treatment and Month 24 | Recurrence of positive culture of respiratory samples after the end of treatment and after cultures become negative during treatment |
| Clinical and radiological post-tuberculosis respiratory sequelae and not related to another pulmonary pathology | treatment completion until Month 24 | Rate of persistent respiratory symptoms such as coughing, dyspnoea, chest pain and/or wheezing |
| Clinical and radiological post-tuberculosis respiratory sequelae and not related to another pulmonary pathology and/or hypoxaemia | treatment completion until Month 24 | Oxygen saturation 88% or lower and PaO2 lower 60 mmHg in ambient air at a distance from an acute episode |
| Clinical and radiological post-tuberculosis respiratory sequelae and not related to another Pulmonary pathology | Baseline, completion or failure treatment (up to 12 months) | and/or impaired lung function as measured by spirometry (FEV1 or FVC \<80% of the theoretical value or FEV1/FVC ratio \<0.70) iv) and/or radiological sequelae defined as the persistence of pulmonary parenchymal abnormalities (nodules, cavities, reticulations, etc.). The anomalies should not be linked to an obvious cause unrelated to tuberculosis (COPD). |
| Functional impact and repercussions of respiratory sequelae | Baseline, Month 12, completion or failure treatment | The 3 components of the St Georges's Respiratory Questionnaire (SGRQ): symptoms (frequency and severity), activity (effects on and adjustment of everyday activities), and psychosocial impact. The total score has a maximum of 100 points, with values ranging from 0 to 100. |
| Quality of life and mental health | Baseline, During anti-tuberculosis treatment up to Month 12 | Psycho-trauma screening (PC-PTSD-5) - 20-item questionnaire, corresponding to the DSM-5 symptom criteria for PTSD. The self-report rating scale is 0-4 for each symptom, reflecting a change from 1-5 in the DSM-IV version. |
| Adherence to tuberculosis treatment | Week 2, Month 2, completion of treatment | Psychoactive substances questionnaire (CAGE-AID) - Item responses on the CAGE are scored 0 or 1, with a higher score an indication of alcohol problems. A total score of 2 or greater is considered clinically significant. A score of 2 to 3 indicates a high index of suspicion and a score of 4 is virtually diagnostic for alcoholism. |
| Health literacy | Baseline, Day 3, Day 7 | Questionnaire |
| Screening for precariousness | Baseline, Day 3, Day 7, Month 2, Month 12 | PRECAR score |
| Complementary support for medical follow-up to compliance with treatment | Month 2, completion of treatment, Month 12 | Questionnaire |
| Only in case of TB meningitis | Baseline, Month 2, completion or failure of treatment (up to 12 months) | Neurocognitive scores - Rankin (MR,) - Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. |
Countries
France
Contacts
CONTACTOlivier MARCY, MD PHD
PRINCIPAL_INVESTIGATORNathalie DE CASTRO, MD PHD
Hôpital Saint Louis Paris
Outcome results
None listed