Lung InfectionPROPAGENCT02173613
Reduction the Duration of Antibiotic Therapy in the Elderly (PROPAGE)
A study testing procalcitonine in people with Lung Infection, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The main objective is to evaluate the interest of the repeated measurement of procalcitonin in patients with pulmonary infection to reduce the duration of antibiotic therapy in comparison with a conventional clinical strategy. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Lung Infection
- What is being tested?
- procalcitonine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2012to Mar 2016
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 80 years
- Started antibiotics for a chest infection
- Procalcitonin performed J0 antibiotic treatment
- Person affiliated to the social security
Who cannot join
- Patients with a documented infection with germs after Listeria spp, Legionella pneumophilia, Mycobacterium tuberculosis
- Patients with a documented infection with a virus or parasite (eg hemorrhagic fever, malaria)
- Patients with endovascular infection associated (endocarditis, pacemaker. Intravascular catheter)
- Patients with lung abscess associated upon entry Patients with a chronic infection associated
- Patients with severe immunosuppression (HIV or transplant)
- Palliative patient
Show all 10Show fewer
- Death within 24 hours of admission to nursing units.
- Presence of antibiotic treatment for chronic infection.
- Patient under guardianship, curatorship or any other administrative or judicial action or deprivation of the right or freedom
- Patients hospitalized without their consent
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital Grenoble
Grenoble, Auvergne-Rhône-Alpes, 38000
About this study
Official title: Reduction of the Duration of Antibiotic Guided by Procalcitonin in Infections Lungs of Hospitalized Elderly: a Randomized
The main objective is to evaluate the interest of the repeated measurement of procalcitonin in patients with pulmonary infection to reduce the duration of antibiotic therapy in comparison with a conventional clinical strategy.
- Conditions
- Lung Infection
- Being tested
- procalcitonine
- Keywords
- infection lung elderly patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procalcitonineOther
The recommendations will be based on the level of PCT: 4 levels of advice will be given:
- It is highly recommended to stop antibiotics if PCT <0.1ng/ml, and the recommended stop if 0.1ng/ml <PCT <0.25 ng / ml.
- It is recommended to continue treatment if 0.25 ng / ml <PCT ng / ml.
- Finally, if the initial PCT greater than 10 ng / ml, a stop will be advised in case of reduction to less than 10% of baseline level.
| Study group | Role | What they receive |
|---|---|---|
| Procalcitonine | Experimental | every 2 days, they will receive the dose of PCT and decide to stop antibiotic treatment according to the algorithm 2. They will notify the results of clinical evaluations in the electronics and all adverse event report forms. Receives: Other: procalcitonine |
| contrôle | No intervention | Only clinical reassessments will be conducted and documented. Data on antibiotic will be listed and all adverse events. Data on the PCT from D2 to D4, D6, D8 and D15 output or will not be available to the prescriber. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of antibiotic therapy
Measured: Success of antibiotic therapy within 45 days of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startAug 2012
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for Lung InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaetan Gavazzi, Principal investigator, University Clinic of Geriatrics Medicine, Division of Medicine multidisciplinary CHU de Grenoble,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173613
- Sponsor's protocol ID
- 1120
- Acronym
- PROPAGE
- Status last verified
- Feb 2016
- First submitted
- 20 Jun 2013
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Polton D, Sermet C. Le vieillissement de la population va-t-il submerger le système de santé ? Bulletin Epidémiologique Hebdomadaire. 2006; 5-6:49-52.
Gaymu J. Aspects démographiques du vieillissement; Bulletin Epidémiologique Hebdomadaire. 2006; 5-6:38-9.
Fein AM. Pneumonia in the elderly: overview of diagnostic and therapeutic approaches. Clin Infect Dis. 1999 Apr;28(4):726-9. doi: 10.1086/515218.
PubMed 10825027van der Steen JT, Ooms ME, van der Wal G, Ribbe MW. Withholding or starting antibiotic treatment in patients with dementia and pneumonia: prediction of mortality with physicians' judgment of illness severity and with specific prognostic models. Med Decis Making. 2005 Mar-Apr;25(2):210-21. doi: 10.1177/0272989X05275400.
PubMed 15800305High KP. Infection as a cause of age-related morbidity and mortality. Ageing Res Rev. 2004 Jan;3(1):1-14. doi: 10.1016/j.arr.2003.08.001. No abstract available.
PubMed 15163100El Solh AA, Aquilina AT, Gunen H, Ramadan F. Radiographic resolution of community-acquired bacterial pneumonia in the elderly. J Am Geriatr Soc. 2004 Feb;52(2):224-9. doi: 10.1111/j.1532-5415.2004.52059.x.
PubMed 14728631Torres OH, Munoz J, Ruiz D, Ris J, Gich I, Coma E, Gurgui M, Vazquez G. Outcome predictors of pneumonia in elderly patients: importance of functional assessment. J Am Geriatr Soc. 2004 Oct;52(10):1603-9. doi: 10.1111/j.1532-5415.2004.52492.x.
PubMed 15450034Bula CJ, Ghilardi G, Wietlisbach V, Petignat C, Francioli P. Infections and functional impairment in nursing home residents: a reciprocal relationship. J Am Geriatr Soc. 2004 May;52(5):700-6. doi: 10.1111/j.1532-5415.2004.52205.x.
PubMed 15086648Harbarth S. Nosocomial transmission of antibiotic-resistant microorganisms. Curr Opin Infect Dis. 2001 Aug;14(4):437-42. doi: 10.1097/00001432-200108000-00007.
PubMed 11964862Fischer JE, Harbarth S, Agthe AG, Benn A, Ringer SA, Goldmann DA, Fanconi S. Quantifying uncertainty: physicians' estimates of infection in critically ill neonates and children. Clin Infect Dis. 2004 May 15;38(10):1383-90. doi: 10.1086/420741. Epub 2004 Apr 29.
PubMed 15156475Christ-Crain M, Stolz D, Bingisser R, Muller C, Miedinger D, Huber PR, Zimmerli W, Harbarth S, Tamm M, Muller B. Procalcitonin guidance of antibiotic therapy in community-acquired pneumonia: a randomized trial. Am J Respir Crit Care Med. 2006 Jul 1;174(1):84-93. doi: 10.1164/rccm.200512-1922OC. Epub 2006 Apr 7.
PubMed 16603606Yoshikawa TT. Antimicrobial resistance and aging: beginning of the end of the antibiotic era? J Am Geriatr Soc. 2002 Jul;50(7 Suppl):S226-9. doi: 10.1046/j.1532-5415.50.7s.2.x.
PubMed 12121517Bonomo RA. Multiple antibiotic-resistant bacteria in long-term-care facilities: An emerging problem in the practice of infectious diseases. Clin Infect Dis. 2000 Dec;31(6):1414-22. doi: 10.1086/317489. Epub 2000 Nov 29.
PubMed 11096012Rooney PJ, O'Leary MC, Loughrey AC, McCalmont M, Smyth B, Donaghy P, Badri M, Woodford N, Karisik E, Livermore DM. Nursing homes as a reservoir of extended-spectrum beta-lactamase (ESBL)-producing ciprofloxacin-resistant Escherichia coli. J Antimicrob Chemother. 2009 Sep;64(3):635-41. doi: 10.1093/jac/dkp220. Epub 2009 Jun 23.
PubMed 19549667Chastre J, Wolff M, Fagon JY, Chevret S, Thomas F, Wermert D, Clementi E, Gonzalez J, Jusserand D, Asfar P, Perrin D, Fieux F, Aubas S; PneumA Trial Group. Comparison of 8 vs 15 days of antibiotic therapy for ventilator-associated pneumonia in adults: a randomized trial. JAMA. 2003 Nov 19;290(19):2588-98. doi: 10.1001/jama.290.19.2588.
PubMed 14625336
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of the Duration of Antibiotic Guided by Procalcitonin in Infections Lungs of Hospitalized Elderly: a Randomized
- ClinicalTrials.gov ID
- NCT02173613
- Acronym / sponsor ID
- PROPAGE / 1120
- Conditions
- Lung Infection
- Keywords
- infection lung elderly patients
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 25 Jun 2014 (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.
The main objective is to evaluate the interest of the repeated measurement of procalcitonin in patients with pulmonary infection to reduce the duration of antibiotic therapy in comparison with a conventional clinical strategy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procalcitonine | Experimental | Other: procalcitonineevery 2 days, they will receive the dose of PCT and decide to stop antibiotic treatment according to the algorithm 2. They will notify the results of clinical evaluations in the electronics and all adverse event report forms. |
| contrôle | No intervention | –Only clinical reassessments will be conducted and documented. Data on antibiotic will be listed and all adverse events. Data on the PCT from D2 to D4, D6, D8 and D15 output or will not be available to the prescriber. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥ 80 years
- Started antibiotics for a chest infection
- Procalcitonin performed J0 antibiotic treatment
- Person affiliated to the social security
Key exclusion criteria (10 listed)
- Patients with a documented infection with germs after Listeria spp, Legionella pneumophilia, Mycobacterium tuberculosis
- Patients with a documented infection with a virus or parasite (eg hemorrhagic fever, malaria)
- Patients with endovascular infection associated (endocarditis, pacemaker. Intravascular catheter)
- Patients with lung abscess associated upon entry Patients with a chronic infection associated
- Patients with severe immunosuppression (HIV or transplant)
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 |
|---|---|---|
| procalcitonineThe recommendations will be based on the level of PCT: 4 levels of advice will be given: * It is highly recommended to stop antibiotics if PCT <0.1ng/ml, and the recommended stop if 0.1ng/ml <PCT <0.25 ng / ml. * It is recommended to continue treatment if 0.25 ng / ml <PCT ng / ml. * Finally, if the initial PCT greater than 10 ng / ml, a stop will be advised in case of reduction to less than 10% of baseline level. | Other | Procalcitonine |
Primary outcome
Duration of antibiotic therapy
Time frame: Success of antibiotic therapy within 45 days of inclusion
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- BackgroundPolton D, Sermet C. Le vieillissement de la population va-t-il submerger le système de santé ? Bulletin Epidémiologique Hebdomadaire. 2006; 5-6:49-52.
- BackgroundGaymu J. Aspects démographiques du vieillissement; Bulletin Epidémiologique Hebdomadaire. 2006; 5-6:38-9.
- Background: PubMed 10825027Fein AM. Pneumonia in the elderly: overview of diagnostic and therapeutic approaches. Clin Infect Dis. 1999 Apr;28(4):726-9. doi: 10.1086/515218.
- Background: PubMed 15800305van der Steen JT, Ooms ME, van der Wal G, Ribbe MW. Withholding or starting antibiotic treatment in patients with dementia and pneumonia: prediction of mortality with physicians' judgment of illness severity and with specific prognostic models. Med Decis Making. 2005 Mar-Apr;25(2):210-21. doi: 10.1177/0272989X05275400.
- Background: PubMed 15163100High KP. Infection as a cause of age-related morbidity and mortality. Ageing Res Rev. 2004 Jan;3(1):1-14. doi: 10.1016/j.arr.2003.08.001. No abstract available.
- Background: PubMed 14728631El Solh AA, Aquilina AT, Gunen H, Ramadan F. Radiographic resolution of community-acquired bacterial pneumonia in the elderly. J Am Geriatr Soc. 2004 Feb;52(2):224-9. doi: 10.1111/j.1532-5415.2004.52059.x.
- Background: PubMed 15450034Torres OH, Munoz J, Ruiz D, Ris J, Gich I, Coma E, Gurgui M, Vazquez G. Outcome predictors of pneumonia in elderly patients: importance of functional assessment. J Am Geriatr Soc. 2004 Oct;52(10):1603-9. doi: 10.1111/j.1532-5415.2004.52492.x.
- Background: PubMed 15086648Bula CJ, Ghilardi G, Wietlisbach V, Petignat C, Francioli P. Infections and functional impairment in nursing home residents: a reciprocal relationship. J Am Geriatr Soc. 2004 May;52(5):700-6. doi: 10.1111/j.1532-5415.2004.52205.x.
- Background: PubMed 11964862Harbarth S. Nosocomial transmission of antibiotic-resistant microorganisms. Curr Opin Infect Dis. 2001 Aug;14(4):437-42. doi: 10.1097/00001432-200108000-00007.
- Background: PubMed 15156475Fischer JE, Harbarth S, Agthe AG, Benn A, Ringer SA, Goldmann DA, Fanconi S. Quantifying uncertainty: physicians' estimates of infection in critically ill neonates and children. Clin Infect Dis. 2004 May 15;38(10):1383-90. doi: 10.1086/420741. Epub 2004 Apr 29.
- Background: PubMed 16603606Christ-Crain M, Stolz D, Bingisser R, Muller C, Miedinger D, Huber PR, Zimmerli W, Harbarth S, Tamm M, Muller B. Procalcitonin guidance of antibiotic therapy in community-acquired pneumonia: a randomized trial. Am J Respir Crit Care Med. 2006 Jul 1;174(1):84-93. doi: 10.1164/rccm.200512-1922OC. Epub 2006 Apr 7.
- Background: PubMed 12121517Yoshikawa TT. Antimicrobial resistance and aging: beginning of the end of the antibiotic era? J Am Geriatr Soc. 2002 Jul;50(7 Suppl):S226-9. doi: 10.1046/j.1532-5415.50.7s.2.x.
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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.
Gaetan Gavazzi principal investigator
University Clinic of Geriatrics Medicine, Division of Medicine multidisciplinary CHU de Grenoble,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing procalcitonine in people with Lung Infection, run by University Hospital, Grenoble at 1 site 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 10 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: stopped early, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early. Results are not available in the source record.
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 (time frame: Success of antibiotic therapy within 45 days of inclusion). 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 NCT02173613, which also lists 46 linked publications.
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 2 May 2022.