Pneumocystis Pneumonia Diagnosis in HIV- Patients

NCT ID: NCT02648256

Last Updated: 2022-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2024-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Polymerase Chain Reaction on Oropharyngeal rinse

Intervention Type: OTHER

Interventions

Polymerase Chain Reaction on Oropharyngeal rinse

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florence Robert-Gangneux, Md, PhD

Role: STUDY_DIRECTOR

CHU Rennes

Locations

CHU Amiens

Amiens, , France

Site Status: RECRUITING

CHU Brest

Brest, , France

Site Status: RECRUITING

CHU Rennes

Rennes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Florence Robert-Gangneux, Md, PhD

Role: CONTACT

florence.robertgangneux@chu-rennes.fr

Anne Ganivet

Role: CONTACT

anne.ganivet@chu-rennes.fr

Other Identifiers

35RC14_9890

Identifier Type: OTHER

Identifier Source: secondary_id

2015-A00408-41

Identifier Type: -

Identifier Source: org_study_id