Antibiotic Resistant InfectionNCT03180983
Antibiotic Use in French Nursing Home
A study testing multimodal intervention in people with Antibiotic Resistant Infection, run by University of Paris 13.
Trial summary
CONTEXT: France is still one of the biggest consumers of antibiotics in Europe. An explanation for this increase in consumption would be aging. Thus, part of this aging population lives in nursing home, where the urinary tract infection is the second most suspected pathology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Resistant Infection
- What is being tested?
- multimodal intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 30 Mar 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- nursing home with registred nursing
- Presence of prescription registration system
- Situated in Paris and surb of Paris
Who cannot join
- n/a
About this study
Official title: Effect of a Nurse-centered Multimodal Intervention on Prescribing Antibiotics in Nursing Home: A Randomized Cluster Study
CONTEXT: France is still one of the biggest consumers of antibiotics in Europe. An explanation for this increase in consumption would be aging. Thus, part of this aging population lives in nursing home, where the urinary tract infection is the second most suspected pathology. However, it can most often be bacteriuria requiring no antibiotic therapy. In nursing home, nurses who alert prescribers when an infection is suspected by describing clinical signs.However, his propensity to perform too rapidly and systematically an examination with dipsticks leads the physician to prescribe antibiotic. This is how a program called ATOUM is set up to reduce the prescription of antibiotics in nursing home. The present ATOUM 4 study builds on this program.
OBJECTIVE: To measure the effect of a nurse-centered multimodal intervention involving training and sensitization on urinary tract infection, asymptomatic bacteriuria, antibiotic resistance and interprofessional communication on antibiotic therapy. METHODS: This will be a randomized double-arm interventional study in 40 nursing home. The intervention group of 20 nursing home will receive a blended-learning intervention.
Read the detailed description
CONTEXT: France is still one of the biggest consumers of antibiotics in Europe. An explanation for this increase in consumption would be aging. Thus, part of this aging population lives in nursing home, where the urinary tract infection is the second most suspected pathology. However, it can most often be bacteriuria requiring no antibiotic therapy. In nursing home, nurses alert prescribers when an infection is suspected by describing clinical signs. However, their propensity to perform too rapidly and systematically an examination with dipsticks leads physicians to prescribe antibiotic. This is how a program called ATOUM is set up to reduce the prescription of antibiotics in nursing home. The present ATOUM 4 study builds on this program.
OBJECTIVE: To measure the effect of a nurse-centered multimodal intervention involving training and sensitization on urinary tract infection, asymptomatic bacteriuria, antibiotic resistance and interprofessional communication on antibiotic therapy. METHODS: This will be a randomized double-arm interventional study in 40 nursing home. The intervention group of 20 nursing home will receive a blended-learning intervention.The primary outcome will be the percentage of reduction in antibiotic prescription at the end of the twelve months following the first visit to nursing home. This data, aggregated by nursing home, will be obtained from the structures concerned via their prescription registration system.
- Conditions
- Antibiotic Resistant Infection
- Being tested
- multimodal intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal interventionBehavioural
Investigators will propose an online training. In addition, investigators will make phone calls to nursing home interlocutor between two nursing home visits. The tools of this intervention will consist on posters , quiz about bacteriuria and urinary tract infection (UTI) and algorithm to help nurse's reasoning when UTI is suspected.
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTIONAL GROUP | Other | The intervention group will receive a blended-learning intervention. Receives: Behavioral: multimodal intervention |
| CONTROL GROUP | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotics prescription for UTI
The percentage of reduction in prescriptions of antibiotics for urinary tract infection
Measured: Twelve months
Secondary outcomes (1)
Total prescriptions of antibiotics
whatever the infection
Measured: Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start1 Mar 2019 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Resistant InfectionStudies of the same condition, open and under way.
- 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
- Model description
- CLUSTER RANDOMIZED STUDY
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Paris 13
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monique ROTHAN-TONDEUR, University of Paris 13
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180983
- Sponsor's protocol ID
- Prot_ATOUM4_V1
- Status last verified
- Jan 2019
- First submitted
- 1 Jun 2017
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Franchi C, Tettamanti M, Pasina L, Djignefa CD, Fortino I, Bortolotti A, Merlino L, Nobili A. Changes in drug prescribing to Italian community-dwelling elderly people: the EPIFARM-Elderly Project 2000-2010. Eur J Clin Pharmacol. 2014 Apr;70(4):437-43. doi: 10.1007/s00228-013-1621-6. Epub 2014 Jan 8.
PubMed 24398968Moreira VG, Lourenco RA. Prevalence and factors associated with frailty in an older population from the city of Rio de Janeiro, Brazil: the FIBRA-RJ Study. Clinics (Sao Paulo). 2013 Jul;68(7):979-85. doi: 10.6061/clinics/2013(07)15.
PubMed 23917663Smith PW, Bennett G, Bradley S, Drinka P, Lautenbach E, Marx J, Mody L, Nicolle L, Stevenson K; Society for Healthcare Epidemiology of America (SHEA); Association for Professionals in Infection Control and Epidemiology (APIC). SHEA/APIC Guideline: Infection prevention and control in the long-term care facility. Am J Infect Control. 2008 Sep;36(7):504-35. doi: 10.1016/j.ajic.2008.06.001. No abstract available.
PubMed 18786461Smith PW, Bennett G, Bradley S, Drinka P, Lautenbach E, Marx J, Mody L, Nicolle L, Stevenson K; SHEA; APIC. SHEA/APIC guideline: infection prevention and control in the long-term care facility, July 2008. Infect Control Hosp Epidemiol. 2008 Sep;29(9):785-814. doi: 10.1086/592416. No abstract available.
PubMed 18767983Marston HD, Dixon DM, Knisely JM, Palmore TN, Fauci AS. Antimicrobial Resistance. JAMA. 2016 Sep 20;316(11):1193-1204. doi: 10.1001/jama.2016.11764.
PubMed 27654605Phillips CD, Adepoju O, Stone N, Moudouni DK, Nwaiwu O, Zhao H, Frentzel E, Mehr D, Garfinkel S. Asymptomatic bacteriuria, antibiotic use, and suspected urinary tract infections in four nursing homes. BMC Geriatr. 2012 Nov 23;12:73. doi: 10.1186/1471-2318-12-73.
PubMed 23176555Chami K, Gavazzi G, Carrat F, de Wazieres B, Lejeune B, Piette F, Rothan-Tondeur M. Burden of infections among 44,869 elderly in nursing homes: a cross-sectional cluster nationwide survey. J Hosp Infect. 2011 Nov;79(3):254-9. doi: 10.1016/j.jhin.2011.08.003. Epub 2011 Sep 6.
PubMed 21899920Inkster T, Marek A, Khanna N. Improving antimicrobial prescribing by targeting clinical nurse practitioners. J Hosp Infect. 2010 Sep;76(1):85-6. doi: 10.1016/j.jhin.2010.05.009. No abstract available.
PubMed 20663586
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nurse-centered Multimodal Intervention on Prescribing Antibiotics in Nursing Home: A Randomized Cluster Study
- ClinicalTrials.gov ID
- NCT03180983
- Acronym / sponsor ID
- Prot_ATOUM4_V1
- Conditions
- Antibiotic Resistant Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Paris 13University, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 8 Jun 2017 (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.
CONTEXT: France is still one of the biggest consumers of antibiotics in Europe. An explanation for this increase in consumption would be aging. Thus, part of this aging population lives in nursing home, where the urinary tract infection is the second most suspected pathology. However, it can most often be bacteriuria requiring no antibiotic therapy. In nursing home, nurses who alert prescribers when an infection is suspected by describing clinical signs.However, his propensity to perform too rapidly and systematically an examination with dipsticks leads the physician to prescribe antibiotic. This is how a program called ATOUM is set up to reduce the prescription of antibiotics in nursing home. The present ATOUM 4 study builds on this program.
OBJECTIVE: To measure the effect of a nurse-centered multimodal intervention involving training and sensitization on urinary tract infection, asymptomatic bacteriuria, antibiotic resistance and interprofessional communication on antibiotic therapy. METHODS: This will be a randomized double-arm interventional study in 40 nursing home. The intervention group of 20 nursing home will receive a blended-learning intervention.
Detailed description
CONTEXT: France is still one of the biggest consumers of antibiotics in Europe. An explanation for this increase in consumption would be aging. Thus, part of this aging population lives in nursing home, where the urinary tract infection is the second most suspected pathology. However, it can most often be bacteriuria requiring no antibiotic therapy. In nursing home, nurses alert prescribers when an infection is suspected by describing clinical signs. However, their propensity to perform too rapidly and systematically an examination with dipsticks leads physicians to prescribe antibiotic. This is how a program called ATOUM is set up to reduce the prescription of antibiotics in nursing home. The present ATOUM 4 study builds on this program.
OBJECTIVE: To measure the effect of a nurse-centered multimodal intervention involving training and sensitization on urinary tract infection, asymptomatic bacteriuria, antibiotic resistance and interprofessional communication on antibiotic therapy. METHODS: This will be a randomized double-arm interventional study in 40 nursing home. The intervention group of 20 nursing home will receive a blended-learning intervention.The primary outcome will be the percentage of reduction in antibiotic prescription at the end of the twelve months following the first visit to nursing home. This data, aggregated by nursing home, will be obtained from the structures concerned via their prescription registration system.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- CLUSTER RANDOMIZED STUDY
| Arm | Type | Receives |
|---|---|---|
| INTERVENTIONAL GROUP | Other | Behavioral: multimodal interventionThe intervention group will receive a blended-learning intervention. |
| CONTROL GROUP | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- nursing home with registred nursing
- Presence of prescription registration system
- Situated in Paris and surb of Paris
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| multimodal interventionInvestigators will propose an online training. In addition, investigators will make phone calls to nursing home interlocutor between two nursing home visits. The tools of this intervention will consist on posters , quiz about bacteriuria and urinary tract infection (UTI) and algorithm to help nurse's reasoning when UTI is suspected. | Behavioural | INTERVENTIONAL GROUP |
Primary outcome
Antibiotics prescription for UTI
Time frame: Twelve months
The percentage of reduction in prescriptions of antibiotics for urinary tract infection
1 secondary outcome
Total prescriptions of antibiotics
Time frame: Twelve months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Background: PubMed 24398968Franchi C, Tettamanti M, Pasina L, Djignefa CD, Fortino I, Bortolotti A, Merlino L, Nobili A. Changes in drug prescribing to Italian community-dwelling elderly people: the EPIFARM-Elderly Project 2000-2010. Eur J Clin Pharmacol. 2014 Apr;70(4):437-43. doi: 10.1007/s00228-013-1621-6. Epub 2014 Jan 8.
- Background: PubMed 23917663Moreira VG, Lourenco RA. Prevalence and factors associated with frailty in an older population from the city of Rio de Janeiro, Brazil: the FIBRA-RJ Study. Clinics (Sao Paulo). 2013 Jul;68(7):979-85. doi: 10.6061/clinics/2013(07)15.
- Background: PubMed 18786461Smith PW, Bennett G, Bradley S, Drinka P, Lautenbach E, Marx J, Mody L, Nicolle L, Stevenson K; Society for Healthcare Epidemiology of America (SHEA); Association for Professionals in Infection Control and Epidemiology (APIC). SHEA/APIC Guideline: Infection prevention and control in the long-term care facility. Am J Infect Control. 2008 Sep;36(7):504-35. doi: 10.1016/j.ajic.2008.06.001. No abstract available.
- Background: PubMed 18767983Smith PW, Bennett G, Bradley S, Drinka P, Lautenbach E, Marx J, Mody L, Nicolle L, Stevenson K; SHEA; APIC. SHEA/APIC guideline: infection prevention and control in the long-term care facility, July 2008. Infect Control Hosp Epidemiol. 2008 Sep;29(9):785-814. doi: 10.1086/592416. No abstract available.
- Background: PubMed 27654605Marston HD, Dixon DM, Knisely JM, Palmore TN, Fauci AS. Antimicrobial Resistance. JAMA. 2016 Sep 20;316(11):1193-1204. doi: 10.1001/jama.2016.11764.
- Background: PubMed 23176555Phillips CD, Adepoju O, Stone N, Moudouni DK, Nwaiwu O, Zhao H, Frentzel E, Mehr D, Garfinkel S. Asymptomatic bacteriuria, antibiotic use, and suspected urinary tract infections in four nursing homes. BMC Geriatr. 2012 Nov 23;12:73. doi: 10.1186/1471-2318-12-73.
- Background: PubMed 21899920Chami K, Gavazzi G, Carrat F, de Wazieres B, Lejeune B, Piette F, Rothan-Tondeur M. Burden of infections among 44,869 elderly in nursing homes: a cross-sectional cluster nationwide survey. J Hosp Infect. 2011 Nov;79(3):254-9. doi: 10.1016/j.jhin.2011.08.003. Epub 2011 Sep 6.
- Background: PubMed 20663586Inkster T, Marek A, Khanna N. Improving antimicrobial prescribing by targeting clinical nurse practitioners. J Hosp Infect. 2010 Sep;76(1):85-6. doi: 10.1016/j.jhin.2010.05.009. No abstract available.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing multimodal intervention in people with Antibiotic Resistant Infection, run by University of Paris 13.
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 1 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: status not confirmed, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Antibiotics prescription for UTI (time frame: Twelve 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 NCT03180983, which also lists 8 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 8 Jan 2019; AzTrials last refreshed its copy on 31 Oct 2026.