Community-acquired PneumoniaCLINPCTNCT01723644
Clinical Reassessment Versus Procalcitonin in Order to Shorten Antibiotic Duration in Community-acquired Pneumonia
A study testing the clinical reassessment arm and the procalcitonin arm in people with Community-acquired Pneumonia, run by Nantes University Hospital at 15 sites in France.
Trial summary
CLINPCT study is a prospective, randomized, controlled, open intervention clinical trial including adult patients admitted in the emergency department with community-acquired pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- the clinical reassessment arm and the procalcitonin arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 15 sitesFrance
- Study dates
- Oct 2012to May 2017
- 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
- written informed consent
- age ≥ 18 years
- admittance from the community or a nursing home with the main diagnosis of community-acquired pneumonia justifying urgent antibiotherapy prescription, hospitalization for at least 6 hours after randomization and chest radiograph compatible with the diagnosis of CAP( Community acquired pneumonia )
Who cannot join
- the inability to give written informed consent
- hospitalization >24 hours
- aspiration pneumonia
- nosocomial pneumonia
- purulent pleurisy
- exacerbation of COPD (chronic obstructive pulmonary disease)
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- neutropenia (<1G/L cells)
- chronic infection with current antibiotherapy
- antibiotherapy before admission for the current infection
- immunosuppression (including prolonged corticotherapy (10 mg of prednisone per day for at least one month)
- active neoplastic disease, organ transplant, pregnancy, HIV diagnosis with a CD4 count<200 cells/μL.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
University hospital of Agen
Agen
University Hospital of Angers
Angers
University Hospital of Brest
Brest
University Hospital of Clermont-Ferrand
Clermont-Ferrand
University Hospital of Grenoble
Grenoble
CHD Vendée
La Roche-sur-Yon
University Hospital of Lille
Lille
CHU de Nantes
Nantes
University Hospital of Bichat Paris
Paris
University Hospital of Bobigny Paris
Paris
University Hospital of Hôtel-Dieu Paris
Paris
University Hospital of Saint Antoine Paris
Paris
University Hospital of Rennes
Rennes
University Hospital of Strasbourg
Strasbourg
University Hospital of Tours
Tours
About this study
Official title: CLINPCT Study: Clinical Reassessment Versus Procalcitonin-guided Algorithm in Order to Reduce Antibiotic Consumption in Community-acquired Pneumonia
CLINPCT study is a prospective, randomized, controlled, open intervention clinical trial including adult patients admitted in the emergency department with community-acquired pneumonia. The objective of this clinical trial is to compare two strategies: clinical reassessment and procalcitonin guided diagnostic and therapeutic strategy in patients with community-acquired pneumonia. In the clinical reassessment arm, antibiotherapy is systematically started in the emergency department. The continuation, the discontinuation or the modification of the antibiotherapy initially prescribed in the ED were made at Day 1 and Day 5 based on clinical assessment. On Day 1, the aim of the clinical reassessment is diagnosis reassessment: to confirm or not the diagnosis of community-acquired pneumonia and to confirm or not the antibiotherapy. On Day 5, the aim of the clinical reassessment is to evaluate the possibility to stop the current antibiotherapy based on criteria for clinical stability defined by the Infectious Diseases Society of America (Temperature ≤37.8°C, Heart rate ≤100 beats/min, Respiratory rate ≤24 breaths/min, Systolic blood pressure ≥90 mm Hg, Arterial oxygen saturation ≥90% or pO2 ≥60 mm Hg on room air). In the procalcitonin arm, initiation and discontinuation of the antibiotherapy is based on the antibiotic stewardship based on procalcitonin (PCT) cut-off ranges previously published. Re-evaluation of the clinical status and measurement of serum PCT levels is mandatory after 6-24 h in all persistently sick and hospitalized patients in who antibiotic are withheld. The PCT algorithm can be overruled by pre-specified criteria, e.g. in patients with immediately life-threatening disease. If the algorithm is overruled and antibiotics are given, an early discontinuation of antibiotic therapy after 3, 5 or 7 days is more or less endorsed based on PCT levels. In hospitalized patients with ongoing antibiotic therapy PCT levels are reassessed on days 3, 5 and 7 and antibiotics will be discontinued using the PCT cut-offs defined above.
- Conditions
- Community-acquired Pneumonia
- Being tested
- the clinical reassessment arm, the procalcitonin arm
- Keywords
- antibiotherapy, community acquired pneumonia, procalcitonin guided guidelines, clinical reassessment
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the clinical reassessment armOther
In the clinical reassessment arm, antibiotherapy is systematically started in the emergency department. The continuation, the discontinuation or the modification of the antibiotherapy initially prescribed in the ED were made at Day 1 and Day 5 based on clinical assessment. On Day 1, the aim of the clinical reassessment is diagnosis reassessment: to confirm or not the diagnosis of community-acquired pneumonia and to confirm or not the antibiotherapy. On Day 5, the aim of the clinical reassessment is to evaluate the possibility to stop the current antibiotherapy based on criteria for clinical stability defined by the Infectious Diseases Society of America
the procalcitonin armOther
In the procalcitonin arm, initiation and discontinuation of the antibiotherapy is based on the antibiotic stewardship based on procalcitonin (PCT) cut-off ranges previously published. Re-evaluation of the clinical status and measurement of serum PCT levels is mandatory after 6-24 h in all persistently sick and hospitalized patients in who antibiotic are withheld. The PCT algorithm can be overruled by pre-specified criteria, e.g. in patients with immediately life-threatening disease. If the algorithm is overruled and antibiotics are given, an early discontinuation of antibiotic therapy after 3, 5 or 7 days is more or less endorsed based on PCT levels. In hospitalized patients with ongoing antibiotic therapy PCT levels are reassessed on days 3, 5 and 7 and antibiotics will be discontinued using the PCT cut-offs defined above.
| Study group | Role | What they receive |
|---|---|---|
| PCT guidance | Other | Group of patient " Procalcitonin " where the initiation and the stop of the antibiotic treatment are made according to a strategy guided by the PCT Receives: Other: the procalcitonin arm |
| clinical reassessment | Other | Group of patient where the initiation and the stop of the antibiotic treatment make following on clinical criteria and paraclinic not including the PCT. Receives: Other: the clinical reassessment arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of antibiotic therapy expressed in days of therapy
antibiotic duration is defined as all antibiotherapy prescribed for a community acquired pneumonia during the 30 day following period Safety Issue: Yes
Measured: Between Day 1 and Day 30
Secondary outcomes (1)
clinical success at Day 30
clinical success is defined as cure of the pneumonia at Day 30 Safety Issue: Clinical cure was defined as either the return to the pre-infection state (i.e. all pneumonia-related signs and symptoms had disappeared and chest X-ray findings had shown improvement) or improvement in related post-infectious stigmata, such that residual symptoms if any did not require additional treatment and were accompanied by improvement or lack of progression based on chest X-ray.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2015
- Study completionMay 2017
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 Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Nantes 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Montassier, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723644
- Sponsor's protocol ID
- RC12_0151
- Acronym
- CLINPCT
- Status last verified
- May 2017
- First submitted
- 6 Nov 2012
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Montassier E, Javaudin F, Moustafa F, Nandjou D, Maignan M, Hardouin JB, Annoot C, Ogielska M, Orer PL, Schotte T, Bouget J, Agha Babaei S, Raynal PA, Eche A, Duc AT, Cojocaru RA, Benaouicha N, Potel G, Batard E, Talan DA. Guideline-Based Clinical Assessment Versus Procalcitonin-Guided Antibiotic Use in Pneumonia: A Pragmatic Randomized Trial. Ann Emerg Med. 2019 Oct;74(4):580-591. doi: 10.1016/j.annemergmed.2019.02.025. Epub 2019 Apr 11.
PubMed 30982631
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINPCT Study: Clinical Reassessment Versus Procalcitonin-guided Algorithm in Order to Reduce Antibiotic Consumption in Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT01723644
- Acronym / sponsor ID
- CLINPCT / RC12_0151
- Conditions
- Community-acquired Pneumonia
- Keywords
- antibiotherapy, community acquired pneumonia, procalcitonin guided guidelines, clinical reassessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 8 Nov 2012 (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.
CLINPCT study is a prospective, randomized, controlled, open intervention clinical trial including adult patients admitted in the emergency department with community-acquired pneumonia. The objective of this clinical trial is to compare two strategies: clinical reassessment and procalcitonin guided diagnostic and therapeutic strategy in patients with community-acquired pneumonia. In the clinical reassessment arm, antibiotherapy is systematically started in the emergency department. The continuation, the discontinuation or the modification of the antibiotherapy initially prescribed in the ED were made at Day 1 and Day 5 based on clinical assessment. On Day 1, the aim of the clinical reassessment is diagnosis reassessment: to confirm or not the diagnosis of community-acquired pneumonia and to confirm or not the antibiotherapy. On Day 5, the aim of the clinical reassessment is to evaluate the possibility to stop the current antibiotherapy based on criteria for clinical stability defined by the Infectious Diseases Society of America (Temperature ≤37.8°C, Heart rate ≤100 beats/min, Respiratory rate ≤24 breaths/min, Systolic blood pressure ≥90 mm Hg, Arterial oxygen saturation ≥90% or pO2 ≥60 mm Hg on room air). In the procalcitonin arm, initiation and discontinuation of the antibiotherapy is based on the antibiotic stewardship based on procalcitonin (PCT) cut-off ranges previously published. Re-evaluation of the clinical status and measurement of serum PCT levels is mandatory after 6-24 h in all persistently sick and hospitalized patients in who antibiotic are withheld. The PCT algorithm can be overruled by pre-specified criteria, e.g. in patients with immediately life-threatening disease. If the algorithm is overruled and antibiotics are given, an early discontinuation of antibiotic therapy after 3, 5 or 7 days is more or less endorsed based on PCT levels. In hospitalized patients with ongoing antibiotic therapy PCT levels are reassessed on days 3, 5 and 7 and antibiotics will be discontinued using the PCT cut-offs defined above.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCT guidance | Other | Other: the procalcitonin armGroup of patient " Procalcitonin " where the initiation and the stop of the antibiotic treatment are made according to a strategy guided by the PCT |
| clinical reassessment | Other | Other: the clinical reassessment armGroup of patient where the initiation and the stop of the antibiotic treatment make following on clinical criteria and paraclinic not including the PCT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- written informed consent
- age ≥ 18 years
- admittance from the community or a nursing home with the main diagnosis of community-acquired pneumonia justifying urgent antibiotherapy prescription, hospitalization for at least 6 hours after randomization and chest radiograph compatible with the diagnosis of CAP( Community acquired pneumonia )
Key exclusion criteria (11 listed)
- the inability to give written informed consent
- hospitalization >24 hours
- aspiration pneumonia
- nosocomial pneumonia
- purulent pleurisy
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 |
|---|---|---|
| the clinical reassessment armIn the clinical reassessment arm, antibiotherapy is systematically started in the emergency department. The continuation, the discontinuation or the modification of the antibiotherapy initially prescribed in the ED were made at Day 1 and Day 5 based on clinical assessment. On Day 1, the aim of the clinical reassessment is diagnosis reassessment: to confirm or not the diagnosis of community-acquired pneumonia and to confirm or not the antibiotherapy. On Day 5, the aim of the clinical reassessment is to evaluate the possibility to stop the current antibiotherapy based on criteria for clinical stability defined by the Infectious Diseases Society of America | Other | clinical reassessment |
| the procalcitonin armIn the procalcitonin arm, initiation and discontinuation of the antibiotherapy is based on the antibiotic stewardship based on procalcitonin (PCT) cut-off ranges previously published. Re-evaluation of the clinical status and measurement of serum PCT levels is mandatory after 6-24 h in all persistently sick and hospitalized patients in who antibiotic are withheld. The PCT algorithm can be overruled by pre-specified criteria, e.g. in patients with immediately life-threatening disease. If the algorithm is overruled and antibiotics are given, an early discontinuation of antibiotic therapy after 3, 5 or 7 days is more or less endorsed based on PCT levels. In hospitalized patients with ongoing antibiotic therapy PCT levels are reassessed on days 3, 5 and 7 and antibiotics will be discontinued using the PCT cut-offs defined above. | Other | PCT guidance |
Primary outcome
duration of antibiotic therapy expressed in days of therapy
Time frame: Between Day 1 and Day 30
antibiotic duration is defined as all antibiotherapy prescribed for a community acquired pneumonia during the 30 day following period Safety Issue: Yes
1 secondary outcome
clinical success at Day 30
Time frame: Day 30
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 14 Sep 2026.
- Results publication: PubMed 30982631Montassier E, Javaudin F, Moustafa F, Nandjou D, Maignan M, Hardouin JB, Annoot C, Ogielska M, Orer PL, Schotte T, Bouget J, Agha Babaei S, Raynal PA, Eche A, Duc AT, Cojocaru RA, Benaouicha N, Potel G, Batard E, Talan DA. Guideline-Based Clinical Assessment Versus Procalcitonin-Guided Antibiotic Use in Pneumonia: A Pragmatic Randomized Trial. Ann Emerg Med. 2019 Oct;74(4):580-591. doi: 10.1016/j.annemergmed.2019.02.025. Epub 2019 Apr 11.
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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.
Emmanuel Montassier principal investigator
Nantes University Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the clinical reassessment arm and the procalcitonin arm in people with Community-acquired Pneumonia, run by Nantes University Hospital at 15 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 11 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
duration of antibiotic therapy expressed in days of therapy (time frame: Between Day 1 and Day 30). 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 NCT01723644, 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 14 Sep 2026.