Pneumocystis Pneumonia Diagnosis in HIV- Patients (PNEUMOQUANT)
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|ClinicalTrials.gov Identifier: NCT02648256|
Recruitment Status : Recruiting
First Posted : January 7, 2016
Last Update Posted : June 9, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia, Pneumocystis||Other: Polymerase Chain Reaction on Oropharyngeal rinse||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pneumocystis Pneumonia Diagnosis in HIV- Patients: Assessment of the Real Time Polymerase Chain Reaction Quantification on Oropharyngeal Rinse|
|Actual Study Start Date :||January 2016|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||August 2021|
Experimental: Oropharyngeal rinse
Polymerase Chain Reaction on Oropharyngeal rinse:
Dosage of Pneumocystis jiroveci will be performed on the broncho-alveolar lavage following the usual routine diagnosis.
Polymerase Chain Reaction will be performed on the broncho-alveolar lavage and the oropharyngeal rinse (not communicated to the clinician result) in the same series, in order to compare the results of the fungal quantification.
Other: Polymerase Chain Reaction on Oropharyngeal rinse
- Positive Predictive Value of Polymerase Chain Reaction on oropharyngeal rinse [ Time Frame: At the end of inclusion period (24 months) ]Definition of a numerical threshold from a multivariate analysis, for positioning the result of this test in combination with other clinical or laboratory parameters.
- Broncho-alveolar lavage Standardization [ Time Frame: At the end of inclusion period (24 months) ]Definition of a quantitative threshold (number of copies / mL) for the interpretation of the Polymerase Chain Reaction on the broncho-alveolar lavage to estimate at best positive predictive value of Pneumocystis Polymerase Chain Reaction
- Evaluation of serum dosage of β-1,3-D glucan [ Time Frame: At the end of inclusion period (24 months) ]Definition of a positivity threshold to evoke a certain Pneumocystis jirovecii pneumonia, alone or in combination with Polymerase Chain Reaction.
- Prevalence of genetic mutations of pneumocystis jirovecii [ Time Frame: At the end of inclusion period (24 months) ]Analysis of the prevalence of mutations in the gene encoding the synthase dihydropteroate Pneumocystis jirovecii in patients with Pneumocystis jirovecii pneumonia or colonized and comparison with previous calculations Brittany and Picardy régions using a parametric test (t test) or nonparametric (Mann-test Whitney)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648256
|Contact: Florence Robert-Gangneux, Md, PhDfirstname.lastname@example.org|
|Contact: Anne Ganivetemail@example.com|
|Amiens, France, 80000|
|Principal Investigator: Anne Totet, MD, PhD|
|Sub-Investigator: Vincent Jounieaux, MD, PhD|
|Sub-Investigator: Jean-Luc Schmit, MD, PhD|
|Brest, France, 29200|
|Principal Investigator: Gilles Nevez, MD-PhD|
|Sub-Investigator: Francis Couturaud, MD-PhD|
|Sub-Investigator: Séverine Ansart, MD-PhD|
|Rennes, France, 35000|
|Sub-Investigator: Jean-Pierre Gangneux, MD, PhD|
|Sub-Investigator: Yves Le Tulzo, MD, PhD|
|Sub-Investigator: Stéphane Jouneau, MD, PhD|
|Sub-Investigator: Pierre Tattevin, MD, PhD|
|Study Director:||Florence Robert-Gangneux, Md, PhD||CHU Rennes|