Clinical Trial: Pneumocystis Pneumonia Diagnosis in HIV- Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pneumocystis Pneumonia Diagnosis in HIV- Patients: Assessment of the Real Time Polymerase Chain Reaction Quantification on Oropharyngeal Rinse

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,

Detailed Summary:
Sponsor: Rennes University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)


Original Secondary Outcome:

  • 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 PJP, 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 regions


Information By: Rennes University Hospital

Dates:
Date Received: January 5, 2016
Date Started: January 2016
Date Completion: January 2019
Last Updated: December 6, 2016
Last Verified: December 2016