Pneumocystis Pneumonia Diagnosis in HIV- Patients

NCT02648256 | Unknown DMC

• 2 other identifiers: 2015-A00408-4135RC14_9890
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 3

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.

Conditions

Pneumonia, Pneumocystis

Keywords

Pneumocystis jirovecii; Polymerase Chain Reaction; Oropharyngeal Rinse

Outcome Measures

Primary Outcomes (1)

• Positive Predictive Value of Polymerase Chain Reaction on oropharyngeal rinse

  Definition of a numerical threshold from a multivariate analysis, for positioning the result of this test in combination with other clinical or laboratory parameters.

  At the end of inclusion period (24 months)

Secondary Outcomes (3)

• Broncho-alveolar lavage Standardization

  At the end of inclusion period (24 months)

• Evaluation of serum dosage of β-1,3-D glucan

  At the end of inclusion period (24 months)

• Prevalence of genetic mutations of pneumocystis jirovecii

  At the end of inclusion period (24 months)

Study Arms (1)

Oropharyngeal rinse

EXPERIMENTAL

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

Interventions

Polymerase Chain Reaction on Oropharyngeal rinse OTHER

Oropharyngeal rinse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (3)

CHU Amiens

Amiens, 80000, France

RECRUITING

CHU Brest

Brest, 29200, France

RECRUITING

CHU Rennes

Rennes, 35000, France

RECRUITING

MeSH Terms

Conditions

Pneumonia, Pneumocystis

Condition Hierarchy (Ancestors)

Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Infections; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Florence Robert-Gangneux, Md, PhD

  CHU Rennes

  STUDY DIRECTOR

Central Study Contacts

Florence Robert-Gangneux, Md, PhD

CONTACT

florence.robertgangneux@chu-rennes.fr

Anne Ganivet

CONTACT

anne.ganivet@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 7, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2024
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

FR (3)