Status:
COMPLETED
Paradoxical Reactions in Non Immuno-compromized Patients With Extrapulmonary Tuberculosis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Extrapulmonary Tuberculosis
Eligibility:
All Genders
18+ years
Brief Summary
Tuberculous paradoxical reactions (PR) are immune reactions occurring during the course of antituberculous treatment and leading to a worsening of tuberculous symptoms after an initial improvement. Th...
Detailed Description
Primary objective : Search for predictive factors of tuberculous paradoxical reaction (PR), with assessment of clinical, radiological and biological factors. Secondary objectives : * Descriptive st...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 14 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 21 2018
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT01252992
Start Date
March 14 2011
End Date
February 21 2018
Last Update
May 28 2021
Active Locations (1)
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1
Georges Pompidou Hospital
Paris, France, 75015