An interventional study of Antibiotic therapy according to the result of mPCR (device) in Community-acquired Pneumonia, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 40 studies in Community-Acquired Pneumonia with a site in France — 11 open to participants now, 11 under way, 5 of them phase 3. Community-Acquired Pneumonia · France.
Among the 40 studies in Community-Acquired Pneumonia with a site in France, this one is the 11th largest by enrollment of the 26 interventional ones that give a count, is one of 2 that started in 2018, is one of 11 with no phase, and was the 18th registered.
325 studies on the registry are indexed under Community-Acquired Pneumonia; 78 are open to participants now.
Browse Community-Acquired Pneumonia studies →11 of the 40 studies in Community-Acquired Pneumonia with a site in France are open now. Recruiting first, the newest first:
University Hospital, Caen · Sites in France
University Hospital, Tours · Sites in France
Ages 18+
Nantes University Hospital · Sites in France
Ages 65+
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+
Biotest · Sites in France, United States, Argentina and 15 more countries
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 41 Community-Acquired Pneumonia studies recruiting now, 29 (71%) set no upper age limit and 9 (22%) stop at 75 or younger; 13 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
40 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 411 is above the median of 246 across 196 interventional studies indexed under Community-Acquired Pneumonia.
Median enrollment 327 across the 26 interventional studies, 365 across the 14 observational. Of the 27 that completed or were terminated, 2 (7%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 40 have an industry lead sponsor. The 10 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.
Assistance Publique - Hôpitaux de Paris has 6 studies filed under Community-Acquired Pneumonia — fewer than ten, so there is no comparison to draw.
4 of the studies in Community-Acquired Pneumonia with a site in France that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05903352Phase 3Assistance Publique - Hôpitaux de ParisCustomized Antibiotic Treatment Duration Among Hospitalized Patients With Moderately Severe Community-Acquired Pneumonia | 2027-05 |
| NCT06229288Phase 3Nantes University HospitalAmoxicillin Alone Versus Amoxicillin/Clavulanate for Community-acquired Pneumonia in Patients Aged 65 Years or Older, and Hospitalized in a Non-intensive Care Unit Ward | 2027-05-25 |
| NCT07070284Joan Sabater-RieraESCAPE10: Epidemiology, Risk Factors, and Outcomes of Severe Community-acquired Pneumonia in Elderly Patients Acquired Pneumonia in Elderly Patients | 2026-11-30 |
| NCT06291012University Hospital, MontpellierStopping Pneumonia Antibiotherapy Regimen Early | 2027-05-01 |
Add all 4 to your calendar (.ics) → With an account.
Among the 40 studies in Community-Acquired Pneumonia with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To assess the effectiveness of a management strategy combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin (intervention) in severe CAP, as compared to a conventional strategy (control).
A multicentre, parallel-group, open-label, randomized controlled trial. The primary assessment criterion est the number of antibiotic-free days at 28 days
Randomization is performed immediately after the inclusion.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Combined use of a respiratory broad panel Multiplex polymerase chain reaction (mPCR) (performed on a lower respiratory tract sample : bronchoalveolar lavage fluid or tracheal aspirate, otherwise sputum) and procalcitonin.
Device: Antibiotic therapy according to the result of mPCR (device)
Antibiotic therapy at discretion of ICU physicians
* Phone call at D28 and D90, unless the patient is still hospitalized; * Collection of a respiratory tract sample (either distal, i.e. tracheal aspirate or bronchoalveolar lavage, or proximal, i.e. sputum) for broad panel respiratory mPCR in the intervention arm. * Collection of an additional respiratory tract sample for biological banking in both arms.
Also known as: Antibiotic therapy to be adapted according to the result of mPCR (device)
The effectiveness of a management combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin in severe CAP, as compared to a conventional strategy
the number of antibiotic free days at D28, which corresponds to the number of days alive without any at Day 28.
Time frame: Day 28
Mortality at 28 (D28) and 90 days (D90);
Mortality rate at D28 and D90
Time frame: Day 28 and day 90
Number of defined daily dose (DDD) per 100 patient days of broad- and narrow-spectrum antibiotics
Number of defined daily dose (DDD) per 100 patient days of broad- and narrow-spectrum antibiotics
Time frame: Day 28
Antibiotics duration at D28
Antibiotics duration at D28
Time frame: Day 28
Number of organ-failure free days (based on SOFA) at D28
Number of organ-failure free days (based on SOFA) at D28
Time frame: Day 28
Incidence rates of bacterial superinfections at D28
Incidence rates of bacterial superinfections at D28
Time frame: Day 28
Incidence rates of colonization/infection with multidrug resistant bacteria and Clostridium difficile infections at D28
Incidence rates of colonization/infection with multidrug resistant bacteria and Clostridium difficile infections at D28
Time frame: Day 28
Incidence rates of relapse (same pathogen) or reinfection (another pathogen) at D28
Incidence rates of relapse (same pathogen) or reinfection (another pathogen) at D28
Time frame: Day 28
Duration of ICU and hospital stay
Duration of ICU and hospital stay
Time frame: Day 90
Cost of the total hospital admissions (including 90-day repeated admissions), ICU costs, cost of the microbiological diagnostic workup;
Cost of the total hospital admissions (including 90-day repeated admissions), ICU costs, cost of the microbiological diagnostic workup;
Time frame: Day 90
Incremental / decremental cost effectiveness ratio in cost per treatment success (90-day composite of all-cause death and infection recurrence).
Incremental / decremental cost effectiveness ratio in cost per treatment success (90-day composite of all-cause death and infection recurrence).
Time frame: Day 90
Sensitivity, specificity, and likelihood ratios of the broad panel mPCR Film Array for the diagnosis of pneumonia, taking the conventional microbiological tests as reference
Sensitivity, specificity, and likelihood ratios of the broad panel mPCR Film Array for the diagnosis of pneumonia, taking the conventional microbiological tests as reference
Time frame: Day 28
Euroquol questionary (EQ-5D-3L)
Euroquol questionary (EQ-5D-3L)
Time frame: Day 90
To assess the operational values of the broad panel mPCR Film Array for the diagnosis of ventilator associated pneumonia (in the intervention group only).
Sensitivity, specificity, and likelihood ratios of the broad panel mPCR Film Array for the diagnosis of ventilator associated pneumonia (in the intervention group only), taking the conventional microbiological tests as reference.
Time frame: Day 28
Ran from Oct 2018 to primary completion in Aug 2022, 46 months.
Of 42 non-industry interventional studies with no phase under Community-Acquired Pneumonia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 38. This study's 46 months is above that.
Counting every sponsor, half of 43 studies reached it within 24 months; a quarter within 14 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Community-Acquired Pneumonia →
Assistance Publique - Hôpitaux de Paris →