PneumocystisOPTIJIROVECNCT06890078
Optimizing the Diagnosis of Pneumocystis in Immunocompromised Patients
An observational study of Pneumocystis and Immunocompromised Patients, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
Evaluate new diagnostic methods using qPCR on non-invasive samples, compared with reference techniques for the positive diagnosis of pneumocystis (PcP) in immunocompromised patients Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumocystis, Immunocompromised Patients
- What is being tested?
- Biological sampling
- How many people
- 240 participants
- Where
- 4 sitesFrance
- Study dates
- 8 Jul 2025to 8 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with suspected pneumocystis
Who may be able to join
- adult patients with suspected pneumocystis
- with an indication for bronchial fibroscopy for BAL or induced sputum
- no opposition to the research from the adult patient or his or her next of kin research for patients unable to express their non-opposition
Who cannot join
- Pneumocystis treated for more than 72 hours
- pregnancy/breast-feeding
- adult patients deprived of liberty, protected
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Hôpital Lariboisière AP-HP Maladies infectieuses
Paris
Agathe Vigouroux, +33 142499066 ext. +33, agathelaure.vigouroux@aphp.fr
- Recruiting
Hôpital Saint Louis AP-HP Maladies infectieuses
Paris
Blandine Denis, +331 42 49 46 83 ext. +33, blandine.denis@aphp.fr
- Recruiting
Hôpital Saint Louis AP-HP Réanimation
Paris
Virginie Lemiale, +331 42 49 91 02 ext. +33, virginie.lemiale@aphp.fr
- Recruiting
Hôpital Saint-Louis AP-HP Pneumologie
Paris
Amira Benattia, +331 42 49 91 65 ext. +33, amira.benattia@aphp.fr
About this study
Official title: Optimisation du Diagnostic de Pneumocystose Chez Les Patients Immunodéprimés
Evaluate new diagnostic methods using qPCR on non-invasive samples, compared with reference techniques for the positive diagnosis of pneumocystis (PcP) in immunocompromised patients
- Conditions
- Pneumocystis, Immunocompromised Patients
- Being tested
- Biological sampling
- Keywords
- immunocompromised patients, pneumocystis
- Medical subject headings
- Pneumonia, Pneumocystis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplingOther
Mouthwash, nasopharyngeal swab, blood sampling
| Study group | Role | What they receive |
|---|---|---|
| Adults with suspicion of pneumocystis | Not described Receives: Other: Biological sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pearson correlation coefficient
Pearson correlation coefficient between the fungal load obtained by PCR on nasopharyngeal swabs nasopharyngeal swab and buccal lavage and that obtained by reference samples (induced sputum or BAL) in patients with confirmed PcP.
Measured: At inclusion
Secondary outcomes (3)
Fungal load by qPCR
Quantitative fungal load results obtained by qPCR on nasopharyngeal swab, mouthwash, induced sputum, BAL
Measured: At inclusion
Fungal load by serum PCR
Quantitative fungal load results obtained by serum PCR
Measured: At inclusion
Beta D glucan blood levels
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start8 Jul 2025
- Primary completion8 Jul 2027 (estimated)
- Study completion8 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumocystisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890078
- Sponsor's protocol ID
- APHP231319
- Acronym
- OPTIJIROVEC
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation du Diagnostic de Pneumocystose Chez Les Patients Immunodéprimés
- ClinicalTrials.gov ID
- NCT06890078
- Acronym / sponsor ID
- OPTIJIROVEC / APHP231319
- Conditions
- Pneumocystis, Immunocompromised Patients
- Keywords
- immunocompromised patients, pneumocystis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 8 Jul 2027 (estimated)
- Study completion
- 8 Jul 2027 (estimated)
- First posted
- 21 Mar 2025 (actual)
- 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.
Evaluate new diagnostic methods using qPCR on non-invasive samples, compared with reference techniques for the positive diagnosis of pneumocystis (PcP) in immunocompromised patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with suspicion of pneumocystis | – | Other: Biological sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with suspected pneumocystis
Key inclusion criteria (3 listed)
- adult patients with suspected pneumocystis
- with an indication for bronchial fibroscopy for BAL or induced sputum
- no opposition to the research from the adult patient or his or her next of kin research for patients unable to express their non-opposition
Key exclusion criteria (3 listed)
- Pneumocystis treated for more than 72 hours
- pregnancy/breast-feeding
- adult patients deprived of liberty, protected
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 |
|---|---|---|
| Biological samplingMouthwash, nasopharyngeal swab, blood sampling | Other | Adults with suspicion of pneumocystis |
Primary outcome
Pearson correlation coefficient
Time frame: At inclusion
Pearson correlation coefficient between the fungal load obtained by PCR on nasopharyngeal swabs nasopharyngeal swab and buccal lavage and that obtained by reference samples (induced sputum or BAL) in patients with confirmed PcP.
3 secondary outcomes
Fungal load by qPCR
Time frame: At inclusion
Fungal load by serum PCR
Time frame: At inclusion
Beta D glucan blood levels
Time frame: At inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumocystis and Immunocompromised Patients, run by Assistance Publique - Hôpitaux de Paris at 4 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agathe Vigouroux, MD (0142494683 ext. +33, agathelaure.vigouroux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pearson correlation coefficient (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026.