Pneumonia, PneumocystisPNEUMOQUANTNCT02648256
Pneumocystis Pneumonia Diagnosis in HIV- Patients
A study testing Polymerase Chain Reaction on Oropharyngeal rinse in people with Pneumonia, Pneumocystis, run by Rennes University Hospital at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Pneumocystis
- What is being tested?
- Polymerase Chain Reaction on Oropharyngeal rinse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2016to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Amiens
Amiens, 80000
CHU Brest
Brest, 29200
CHU Rennes
Rennes, 35000
About this study
Official title: Pneumocystis Pneumonia Diagnosis in HIV- Patients: Assessment of the Real Time Polymerase Chain Reaction Quantification on Oropharyngeal Rinse
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.
Read more
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
- Being tested
- Polymerase Chain Reaction on Oropharyngeal rinse
- Keywords
- Pneumocystis jirovecii, Polymerase Chain Reaction, Oropharyngeal Rinse
- Medical subject headings
- Pneumonia, Pneumocystis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymerase Chain Reaction on Oropharyngeal rinseOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Polymerase Chain Reaction on Oropharyngeal rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of inclusion period (24 months)
Secondary outcomes (3)
Broncho-alveolar lavage Standardization
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
Measured: At the end of inclusion period (24 months)
Evaluation of serum dosage of β-1,3-D glucan
Definition of a positivity threshold to evoke a certain Pneumocystis jirovecii pneumonia, alone or in combination with Polymerase Chain Reaction.
Measured: At the end of inclusion period (24 months)
Prevalence of genetic mutations of pneumocystis jirovecii
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)
Measured: At the end of inclusion period (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2023
- Study completionAug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, PneumocystisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Robert-Gangneux, Md, PhD, Study director, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648256
- Sponsor's protocol ID
- 2015-A00408-41
- Other IDs
- 35RC14_9890
- Acronym
- PNEUMOQUANT
- Status last verified
- Jun 2026
- First submitted
- 5 Jan 2016
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Robert-Gangneux F, Nevez G, Damiani C, Le Guen Y, Gut-Gobert C, Bazire A, Totet A, Jounieaux V, Le Berre R, Thepault F, Tattevin P, Barnier A, Jouneau S, Reizine F, Kerjouan M, Chauvin P, Rousseau C, Garlantezec R, Gangneux JP, Camus C, Le Gal S. Oral Wash Polymerase Chain Reaction Improves the Diagnosis of Pneumocystis Pneumonia in Immunocompromised Patients Without HIV: A Prospective Multicenter Study. Clin Infect Dis. 2026 Oct 28;83(4):e769-e776. doi: 10.1093/cid/ciag356.
PubMed 42272071
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumocystis Pneumonia Diagnosis in HIV- Patients: Assessment of the Real Time Polymerase Chain Reaction Quantification on Oropharyngeal Rinse
- ClinicalTrials.gov ID
- NCT02648256
- Acronym / sponsor ID
- PNEUMOQUANT / 2015-A00408-41
- Conditions
- Pneumonia, Pneumocystis
- Keywords
- Pneumocystis jirovecii, Polymerase Chain Reaction, Oropharyngeal Rinse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jul 2023 (actual)
- Study completion
- Aug 2024 (actual)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oropharyngeal rinse | Experimental | Other: Polymerase Chain Reaction on Oropharyngeal rinsePolymerase 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polymerase Chain Reaction on Oropharyngeal rinse | Other | Oropharyngeal rinse |
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.
3 secondary outcomes
Broncho-alveolar lavage Standardization
Time frame: At the end of inclusion period (24 months)
Evaluation of serum dosage of β-1,3-D glucan
Time frame: At the end of inclusion period (24 months)
Prevalence of genetic mutations of pneumocystis jirovecii
Time frame: At the end of inclusion period (24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Derived from this study: PubMed 42272071Robert-Gangneux F, Nevez G, Damiani C, Le Guen Y, Gut-Gobert C, Bazire A, Totet A, Jounieaux V, Le Berre R, Thepault F, Tattevin P, Barnier A, Jouneau S, Reizine F, Kerjouan M, Chauvin P, Rousseau C, Garlantezec R, Gangneux JP, Camus C, Le Gal S. Oral Wash Polymerase Chain Reaction Improves the Diagnosis of Pneumocystis Pneumonia in Immunocompromised Patients Without HIV: A Prospective Multicenter Study. Clin Infect Dis. 2026 Oct 28;83(4):e769-e776. doi: 10.1093/cid/ciag356.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Robert-Gangneux, Md, PhD study director
Rennes University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polymerase Chain Reaction on Oropharyngeal rinse in people with Pneumonia, Pneumocystis, run by Rennes University Hospital at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Predictive Value of Polymerase Chain Reaction on oropharyngeal rinse (time frame: At the end of inclusion period (24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02648256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.