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NCT01252992: PARATB
Paradoxical Reactions in Non Immuno-compromized Patients With Extrapulmonary Tuberculosis
trial testing Genetic analysis in Extrapulmonary Tuberculosis in 135 participants. Completed in 21 February 2018.
21 February 2018
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 135 |
| Start date | 14 March 2011 |
| Primary completion | 21 February 2018 |
| Estimated completion | 21 February 2018 |
| Sites | 1 location across France |
Drugs / interventions tested
- Genetic analysis
- Body scan (CERVICO THORACO ABDOMINAL) + Cranian IRM
- Immunologic analysis
- QuantiferonTB Gold test
Conditions studied
- Extrapulmonary Tuberculosis — all drugs for Extrapulmonary Tuberculosis →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
18 and older, any sex, with Extrapulmonary Tuberculosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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. This phenomenon has very extensively studied in HIV infected patients where it corresponds to the so called IRIS (immune reconstitution syndrome). However, it laso occurs in non immuno-compromized patients, especially those with extra-pulmonary localization of tuberculosis. The aim of the study is to look for risk factors of paradoxical reaction in non immuno-compromized patients with extra-pulmonary tuberculosis. The investigators will consider clinical, radiological and biological variables, including specific immune and genetic markers. Our secondary goals are to estimate the incidence of PR, describe their natural history; characterize the type of immune response they correspond to, and look for better diagnostic tools.The immunological characterization and the finding of predictive factors of PR, especially the genetic ones will allow a better understanding of biological mechanisms that lead to their occurrence during extra-pulmonary tuberculosis treatment. The establishment of predictive criteria could permit a better surveillance of at risk patients for a rapid treatment, or even a prevention of PR. The establishment of new diagnostic criteria at the time of PR could avoid numerous invasive diagnostic procedures, surgery and/or useless prolongation of antibiotic treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01252992
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Extrapulmonary Tuberculosis
Currently open trials in the same condition.
- NCT06875336 — A Multicentric Cohort and Biomarker Study for Improved Care of Patients with Extrapulmonary Tuberculosis · recruiting
Other Assistance Publique - Hôpitaux de Paris trials
Trials by the same sponsor.
- NCT07443436 — Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants · Phase 2 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01252992 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 28 May 2021
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing