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Pneumocystis Pneumonia Diagnosis in HIV- Patients (PNEUMOQUANT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02648256
Recruitment Status : Recruiting
First Posted : January 7, 2016
Last Update Posted : June 9, 2020
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1250 participants
Allocation: N/A
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 : July 2020
Estimated Study Completion Date : August 2021

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

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02648256

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Contact: Florence Robert-Gangneux, Md, PhD
Contact: Anne Ganivet

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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
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Study Director: Florence Robert-Gangneux, Md, PhD CHU Rennes
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Responsible Party: Rennes University Hospital Identifier: NCT02648256    
Other Study ID Numbers: 2015-A00408-41
35RC14_9890 ( Other Identifier: Other Identifier )
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Keywords provided by Rennes University Hospital:
Pneumocystis jirovecii
Polymerase Chain Reaction
Oropharyngeal Rinse
Additional relevant MeSH terms:
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Pneumonia, Pneumocystis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Fungal
Pneumocystis Infections