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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 : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.


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)
Primary Purpose: Diagnostic
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 : January 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Pneumonia

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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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


Contacts
Contact: Florence Robert-Gangneux, Md, PhD florence.robertgangneux@chu-rennes.fr
Contact: Anne Ganivet anne.ganivet@chu-rennes.fr

Locations
France
CHU Amiens Recruiting
Amiens, France, 80000
Principal Investigator: Anne Totet, MD, PhD         
Sub-Investigator: Vincent Jounieaux, MD, PhD         
Sub-Investigator: Jean-Luc Schmit, MD, PhD         
CHU Brest Recruiting
Brest, France, 29200
Principal Investigator: Gilles Nevez, MD-PhD         
Sub-Investigator: Francis Couturaud, MD-PhD         
Sub-Investigator: Séverine Ansart, MD-PhD         
CHU Rennes Recruiting
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         
Sponsors and Collaborators
Rennes University Hospital
Investigators
Study Director: Florence Robert-Gangneux, Md, PhD CHU Rennes

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02648256     History of Changes
Other Study ID Numbers: 2015-A00408-41
35RC14_9890 ( Other Identifier: Other Identifier )
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by Rennes University Hospital:
Pneumocystis jirovecii
Polymerase Chain Reaction
Oropharyngeal Rinse

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Pneumocystis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections