Pneumocystis Pneumonia Diagnosis in HIV- Patients

  • STATUS
    Recruiting
  • days left to enroll
    21
  • participants needed
    1250
  • sponsor
    Rennes University Hospital
Updated on 24 January 2021
Investigator
Florence Robert-Gangneux, Md, PhD
Primary Contact
CHU Brest (0.6 mi away) Contact
+2 other location
early diagnosis
pneumonia
bronchoalveolar lavage
cancer
corticosteroids
mechanical ventilation
immunodeficiency
HIV Infection
deficiency
AIDS
opportunistic infection
cytostatics

Summary

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.

Details
Condition Pneumocystosis
Treatment Polymerase Chain Reaction on Oropharyngeal rinse
Clinical Study IdentifierNCT02648256
SponsorRennes University Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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

Exclusion Criteria

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
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