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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01834-43 | Other Identifier | ID RCB |
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| Name | Class |
|---|---|
| University of Bordeaux | OTHER |
| Amiens University Hospital | OTHER |
| Centre National de la Recherche Scientifique, France | OTHER |
| Saint Antoine University Hospital |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Intervention | People starting treatment for tuberculosis disease |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with successful anti-tuberculosis treatment outcome, defined as definite or probable cure, by 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. | through treatment completion; Month 12 |
| Success of the anti-tuberculosis treatment | 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. | through treatment completion; Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Early microbiological response | 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. | Month 2 |
| Positive culture |
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Inclusion Criteria:
Exclusion Criteria:
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All persons included in the cohort will be followed up as part of routine care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivier MARCY, MD PHD | Contact | +33 5 57 57 17 67 | olivier.marcy@u-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nathalie DE CASTRO, MD PHD | Hôpital Saint Louis Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP Hôpital Saint Louis - Service des Maladies Infectieuses et Tropicales | Not yet recruiting | Paris | 75010 | France |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| OTHER |
| University of Lyon | OTHER |
| Claude Bernard University | OTHER |
| University Hospital, Bordeaux | OTHER |
| Saint-Louis Hospital, Paris, France | OTHER |
| Centre Hospitalier Universitaire, Amiens | OTHER |
| Hôpital Jean Verdier | OTHER |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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Number of Positive culture after 5 months of treatment |
| Month 5 |
| Tuberculosis-related death | Number of deaths directly related to tuberculosis in the year following diagnosis | Month 5 |
| Premature treatment interruption without resumption | Number of interrupted treatments before the end of the planned duration and not resumed (for a reason other than a rejected tuberculosis diagnosis | Month 5 |
| Ongoing treatment at Month 12 due to interruption, resistance, adverse events, or initial failure | Number of treatment ongoing at 12 months because interrupted for more than two months or modified for resistance, side effects/intolerance, initial failure | Month 12 |
| Transfer or loss to follow-up | Number of transfers or loss of follow-up | Month 5 |
| All-cause mortality | Occurrence and causes of death after tuberculosis diagnosis after inclusion and causes | Until Month 24 |
| Tuberculosis relapse | Recurrence of positive culture of respiratory samples after the end of treatment and after cultures become negative during treatment | Between end of treatment and Month 24 |
| Clinical and radiological post-tuberculosis respiratory sequelae and not related to another pulmonary pathology | Rate of persistent respiratory symptoms such as coughing, dyspnoea, chest pain and/or wheezing | treatment completion until Month 24 |
| Clinical and radiological post-tuberculosis respiratory sequelae and not related to another pulmonary pathology and/or hypoxaemia | Oxygen saturation 88% or lower and PaO2 lower 60 mmHg in ambient air at a distance from an acute episode | treatment completion until Month 24 |
| Clinical and radiological post-tuberculosis respiratory sequelae and not related to another Pulmonary pathology | 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). | Baseline, completion or failure treatment (up to 12 months) |
| Functional impact and repercussions of respiratory sequelae | 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. | Baseline, Month 12, completion or failure treatment |
| Functional impact and repercussions of respiratory sequelae | Functional evaluation measured by the 6-minute walk test | Completion treatment, Month 24 |
| Functional impact and repercussions of respiratory sequelae | Spirometry - FEV1/FVC ratio of greater than 0.70 and both FEV1 and FVC above 80% of the predicted value | Completion treatment (up to 12 months), Month 24 |
| Functional impact and repercussions of respiratory sequelae | Pulse oximetry | Baseline, week 2, Month 12, completion or failure of treatment (up to 12 months), Month 24 |
| Functional impact and repercussions of respiratory sequelae | Imaging (scanner) | Baseline, Month 2, completion or failure of treatment, Month 24 |
| Functional impact and repercussions of respiratory sequelae | Chest X-ray2.Other imaging for extrapulmonary involvement | Baseline, Month 2, completion or failure of treatment (up to 12 months) |
| Quality of life and mental health | 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. | Baseline, During anti-tuberculosis treatment up to Month 12 |
| Quality of life and mental health | Anxiety questionnaire (GAD-7) - Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety. EQ-5D-5L - The UI is calculated from patient scoring of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). For each dimension, participants are asked to mark between 1: 'no problems' to 5: 'unable to/extreme problems'. Depression (PHQ-9) -Total scores of 5, 10, 15 and 20 represent the thresholds for mild, moderate, moderately severe and severe depression, respectively. Note: Question 9 is a single screening question on suicide risk. | Baseline, Month 2, completion or failure of treatment (up to 12 months) |
| Quality of life and mental health | 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.Hunger scale (HHS) - rating scale from 0 to 10, where 0 is painful hunger and 10 is painful fullness. | Baseline, Day 3, Day 7 |
| Quality of life and mental health | Stigma scale - Responses to each item are measured on a five-point scale (ranging from zero 'strongly disagree' to four 'strongly agree'). Higher scores indicate higher levels of depression stigma. | Completion of treatment (up to 12 months) |
| Quality of life and mental health | Alcohol questionnaire (AUDIT-C) - scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety. Tobacco questionnaire (Fagerström) - Test for Nicotine Dependence, the three yes/no items are scored 0 (no) and 1 (yes). The three multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. | Baseline to Month 24 |
| Adherence to tuberculosis 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. | Week 2, Month 2, completion of treatment |
| Health literacy | Questionnaire | Baseline, Day 3, Day 7 |
| Screening for precariousness | PRECAR score | Baseline, Day 3, Day 7, Month 2, Month 12 |
| Complementary support for medical follow-up to compliance with treatment | Questionnaire | Month 2, completion of treatment, Month 12 |
| Only in case of TB meningitis | 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. | Baseline, Month 2, completion or failure of treatment (up to 12 months) |
| Service de pneumologie et maladies infectieuses, Centre hospitalier Delafontaine | Recruiting | Saint-Denis | France |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |