Informations générales (source: ClinicalTrials.gov)
Pneumocystis Pneumonia Diagnosis in HIV- Patients: Assessment of the Real Time Polymerase Chain Reaction Quantification on Oropharyngeal Rinse (PNEUMOQUANT)
Interventional
N/A
Rennes University Hospital (Voir sur ClinicalTrials)
janvier 2016
août 2024
03 août 2024
Pneumocystis jirovecii pneumonia is a serious and frequent infection in immunocompromised
patients, whose evolution is potentially fatal if untreated. It is the most common
opportunistic infections classifying patients infected with human immunodeficiency virus
(human immunodeficiency virus +) at the stage acquired immune deficiency syndrome. Data
from the french Institute for Health Watch showed in 2011 that 31% of 1400 cases of
acquired immune deficiency syndrome were revealed by Pneumocystis jirovecii pneumonia.
Pneumocystis jirovecii pneumonia also increasingly concerns immunocompromised human
immunodeficiency virus negative patients, due to the increasing use of immunosuppressive
therapies (including corticosteroids), of anticancer cytostatics and biotherapies, in the
context of grafts, transplants, but also from autoimmune or inflammatory chronic
diseases.
Recent data show that the number of cases occurring in patients Pneumocystis jirovecii
pneumonia human immunodeficiency virus - in France is now higher than the cases occurring
in Pneumocystis jirovecii pneumonia +. The severity of the Pneumocystis jirovecii
pneumonia is increased in patients with human immunodeficiency virus -, in whom the
evolution is faster, with mechanical ventilation often required and higher mortality,
requiring a fast and early diagnosis. Routine diagnosis relies on the detection of the
fungus in the bronchoalveolar lavage, using stains (May Grunwald Giemsa or
immunofluorescence) and Polymerase Chain Reaction. Polymerase Chain Reaction provides a
diagnostic gain in immunocompromised patients not infected with human immunodeficiency
virus that may present a pejorative table quickly despite low fungal burden. However, the
deoxyribonucleic acid of the fungus can sometimes be detected in the absence of scalable
Pneumocystis jirovecii pneumonia, and then shows a pulmonary colonization by Pneumocystis
jirovecii. It is therefore important to improve the positive predictive value of
Pneumocystis Polymerase Chain Reaction, to guide the management of optimal patient.
In this work, the investigators propose to evaluate the Polymerase Chain Reaction on
oropharyngeal rinse, non-invasive sampling and therefore probably less often positive and
specific active infection. The investigators will develop a quantitative Polymerase Chain
Reaction to identify a fungal load threshold number of copies / mL for diagnosing
Pneumocystis jirovecii pneumonia with better positive predictive value.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Brest - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| CHU Rennes - 35000 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Amiens - 80000 - Amiens - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Age over 18 years
- Clinical or radiological indication for a broncho-alveolar lavage to search
infectious agents including Pneumocystis jirovecii
- Patients with risk factors for developing a Pneumocystis jirovecii pneumonia :
underlying malignancy (solid cancer, hematologic disease), organ transplant or
hematopoietic stem cells, autoimmune disease or chronic inflammatory disease
justifying immunosuppressive therapy (chemotherapy anticancer, immunomodulatory,
biotherapy, corticosteroids) or patient treated with corticosteroids for more than a
month or congenital immune deficiency or other causes of immunosuppression
(excluding human immunodeficiency virus) at the discretion of the clinician,
- Informed consent given.
- Age over 18 years
- Clinical or radiological indication for a broncho-alveolar lavage to search
infectious agents including Pneumocystis jirovecii
- Patients with risk factors for developing a Pneumocystis jirovecii pneumonia :
underlying malignancy (solid cancer, hematologic disease), organ transplant or
hematopoietic stem cells, autoimmune disease or chronic inflammatory disease
justifying immunosuppressive therapy (chemotherapy anticancer, immunomodulatory,
biotherapy, corticosteroids) or patient treated with corticosteroids for more than a
month or congenital immune deficiency or other causes of immunosuppression
(excluding human immunodeficiency virus) at the discretion of the clinician,
- Informed consent given.
- Patient human immunodeficiency virus positive
- Contraindication to the achievement of broncho-alveolar lavage,
- Contraindication to the achievement of a Oropharyngeal rinse (disorder of
consciousness, swallowing disorder),
- Prophylaxis with cotrimoxazole or aerosol pentamidine,
- Empirical curative treatment with cotrimoxazole or other curative therapeutic
alternative (pentamidine, atovaquone, dapsone, clindamycin-primaquine) started for
more than 48 hours,
- Major person under legal protection (backup justice, trusteeship, guardianship),
person deprived of liberty.