Clinical trial NCT02648256: Pneumocystis Pneumonia Diagnosis in HIV- Patients
Official title: Pneumocystis Pneumonia Diagnosis in HIV- Patients: Assessment of the Real Time Polymerase Chain Reaction Quantification on Oropharyngeal Rinse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pneumonia, Pneumocystis
Keywords: Pneumocystis jirovecii
Polymerase Chain Reaction
Oropharyngeal Rinse
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 1250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Positive Predictive Value of Polymerase Chain Reaction on oropharyngeal rinse
timeFrame: At the end of inclusion period (24 months)
Secondary outcomes:
measure: Broncho-alveolar lavage Standardization
timeFrame: At the end of inclusion period (24 months)
measure: Evaluation of serum dosage of β-1,3-D glucan
timeFrame: At the end of inclusion period (24 months)
measure: Prevalence of genetic mutations of pneumocystis jirovecii
timeFrame: At the end of inclusion period (24 months)
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Brest
country: France
facility: CHU Brest
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: CHU Rennes
name: Florence Robert-Gangneux, Md, PhD
role: STUDY_DIRECTOR
References: