Paradoxical Reactions in Non Immuno-compromized Patients With Extrapulmonary Tuberculosis
Mots clés
Abstrait
La description
Primary objective :
Search for predictive factors of tuberculous paradoxical reaction (PR), with assessment of clinical, radiological and biological factors.
Secondary objectives :
- Descriptive study of PR : incidence, clinical and radiological presentation, clinical course ; characterization of mycobacteria strains- Search for genetic predictive factors of PR
- Characterization of the specific immune antigene response during PR et analysis of different cell subsets implicated in peripheral blood and locally- Characterization of the anti-bacterial immune response before and after antituberculous treatment
- Preliminary search for new diagnosis criteria including clinical, biological (immune and genetic) and radiological factors.Methodology : Multicentric cohort study for a total of 5 years (4 years of enrolment and one year of follow-up, with biological collection for scientific purpose
Inclusion Status of patients (determined by a validation comity at M6)
- PR+ : PR with clinical symptoms
- rPR : pure radiological PR
- PR- : absence of RP after 6 months of treatment Development of the study
Primary outcome :
- Association between PR+ occurrence and clinical, biological and radiological factors harvested at the diagnosis of tuberculosis..
Secondary outcomes :
- Association between PR+ and rPR
- occurrence and the above quoted factors.- Descriptive study : clinical, biological, and radiological presentation of PR+ and rPR, characterization of isolated BK strains in PR+ patients
- Immunological study in 20 PR+ patients and 20 RP- : 20 patients per group will allow a 80% power to detect, by means of bilateral Mann-Whitney test with alpha=5%, any difference in the count of specific cells corresponding to at least one standard deviation of the primary immunological outcome
- controls: variation between tuberculosis diagnostic and either PR time or M2 (in absence of PR), of the specific cells, macrophages, dendritic cells, gamma-delta lymphocytes, NK et CD4 cells counts
- Preliminary search for diagnostic criteria that can be used at the time of PR occurrence: variation between D0 and the PR of clinical, biological, radiological immunological et genomic of PR+ patients.
- Evolution specific and non specific immune response of mycobacterial antigen at tuberculosis diagnosis during tuberculosis treatment and after. Sample size calculation
- prognostic study : Patients will be recruited and followed until the achievement of a 20 PR+ sample. The investigators will have to analyze 200 patients.
Rendez-vous
| Dernière vérification: | 11/30/2019 |
| Première soumission: | 11/26/2010 |
| Inscription estimée soumise: | 12/01/2010 |
| Première publication: | 12/02/2010 |
| Dernière mise à jour soumise: | 12/03/2019 |
| Dernière mise à jour publiée: | 12/04/2019 |
| Date de début réelle de l'étude: | 03/13/2011 |
| Date d'achèvement primaire estimée: | 02/20/2018 |
| Date estimée d'achèvement de l'étude: | 02/20/2018 |
Condition ou maladie
Intervention / traitement
Genetic: Genetic analysis
Radiation: Body scan (CERVICO THORACO ABDOMINAL) + Cranian IRM
Other: Immunologic analysis
Other: 1:paradoxical reaction negative (RP+)
Phase
Groupes d'armes
| Bras | Intervention / traitement |
|---|---|
| 1:paradoxical reaction negative (RP-) control group with tuberculosis but without paradoxical reaction | |
| 1:paradoxical reaction negative (RP+) group with tuberculosis and paradoxical reaction | Other: 1:paradoxical reaction negative (RP+) at M0, M2, M6 and in case of PR+. |
Critère d'éligibilité
| Âges éligibles aux études | 18 Years À 18 Years |
| Sexes éligibles à l'étude | All |
| Méthode d'échantillonnage | Non-Probability Sample |
| Accepte les bénévoles en santé | Oui |
| Critères | Inclusion Criteria: - Extrapulmonary tuberculosis, with associated pulmonary localization or not - Treatment started less than 5 days ago - Negative HIV serology - Social insurance - Age >= 18- Foreseeable follow-up of at last one year - Signed Free Inform Consent Exclusion Criteria: - HIV infection - immuno-suppressive treatment (including corticosteroids > 10 mg /d prednisone equivalent, however patients with corticotherapy could be included during the phase 2 of the study) - central neurological system tuberculosis and tuberculous pericarditis - pure pulmonary tuberculosis - multiresistant tuberculosis - pregnancy or breast feeding |
Résultat
Mesures des résultats primaires
1. Risk factors of paradoxical reaction [at 6 months]
Mesures des résultats secondaires
1. Incidence and natural history of paradoxical reactions [during the first 6 months]
2. Immune description of paradoxical reactions [during the first 6 months]
3. Preliminary study of Diagnosis factors of paradoxical reaction [during the first 6 months]
