Infectious DiseaseNCT03636711
Antibiotic Stewardship in Infectious Disease Departement
An observational study of Infectious Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Consensual antibiotic protocols have been developed and validated locally by infectious disease specialists, internists and emergency physicians, in order to encourage their compliance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Disease
- What is being tested?
- antibiotic protocol, according to a syndromic approach
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2018to Jan 2022
- How long will I take part?
- 10 Days
- Phase
- Observational
- 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
Study population: Patients who present a infectious syndrom
Who may be able to join
- Patient admitted to emergency for infectious syndrome
- Patient > 18 years old.
- Patient who accept to have his medical records reviewed for research.
Who cannot join
- Patient < 18 years old.
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13005
CECILE LAVOUTE, PHD, +33 491381878, cecile.lavoute@ap-hm.fr
About this study
Official title: Adherence to Anti-infectious Treatment Protocols in Emergencies and Short-term Hospitalization at the Infectious Disease Department"
Consensual antibiotic protocols have been developed and validated locally by infectious disease specialists, internists and emergency physicians, in order to encourage their compliance. A preliminary study was conducted from June 2015 to February 2016, including 622 patients admitted to the emergency department for infectious syndrome such as /
- Pneumoniae
- Urinary tract infection
- Cellulitis
- Meningitis
- Malaria
- Febrile neutropenia
- Febrile acute diarrhea
- Fever back to the tropics
- Angina
- sexually transmitted infection This prospective study will observe and analyze the adherence of prescribers to these protocols. With description of patients who benefited or not the antibiotic protocol, according to a syndromic approach and analysis of the causes of non-adherence to the protocols. In order to limit the length of stay and reduce the cost of hospitalization..
Read the detailed description
Consensual antibiotic protocols have been developed and validated locally by infectious disease specialists, internists and emergency physicians, in order to encourage their compliance. A preliminary study was conducted from June 2015 (setting up protocols) to February 2016, including 622 patients admitted to the emergency department for infectious syndrome such as /
- Pneumoniae
- Urinary tract infection
- Cellulitis
- Meningitis
- Malaria
- Febrile neutropenia
- Febrile acute diarrhea
- Fever back to the tropics
- Angina
- sexually transmitted infection This prospective study will observe and analyze the adherence of prescribers to these protocols. With description of patients who benefited or not the antibiotic protocol, according to a syndromic approach and analysis of the causes of non-adherence to the protocols. In order to limit the length of stay and reduce the cost of hospitalization..
- Conditions
- Infectious Disease
- Being tested
- antibiotic protocol, according to a syndromic approach
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibiotic protocol, according to a syndromic approachOther
Description of patients who benefited or not the antibiotic protocol, according to a syndromic approach and analysis of the causes of non-adherence to the protocols
| Study group | Role | What they receive |
|---|---|---|
| experimental group | • Patient admitted to emergency for infectious syndrome Description of antibiotic protocol, according to a syndromic approach will be performed Receives: Other: antibiotic protocol, according to a syndromic approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
List of Antibiotic treatment
Description of the prescribed antibiotic treatment depending of infectious syndrome: name, duration for each treatment during hospitalization
Data will be collected in the medical files:
- date of introduction of antibiotic treatment
- withdrawal dates
- stop dates
- antibiotic classes
Measured: up to 12 weeks
Adverse events
Description of the cause of non adherence to antibiotic treatment initiates at hospital admission of antibiotherapy:
Data will be collected in the medical files of patients:
events leading to withdrawal or stop treatment (insufficiency renal, allergic reaction ... etc) date of events aggravation or recovery
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study startSep 2018 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- 2,000 participants (estimated)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636711
- Sponsor's protocol ID
- 2018-24
- Status last verified
- Aug 2018
- First submitted
- 9 Jul 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Anti-infectious Treatment Protocols in Emergencies and Short-term Hospitalization at the Infectious Disease Department"
- ClinicalTrials.gov ID
- NCT03636711
- Acronym / sponsor ID
- 2018-24
- Conditions
- Infectious Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 17 Aug 2018 (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.
Consensual antibiotic protocols have been developed and validated locally by infectious disease specialists, internists and emergency physicians, in order to encourage their compliance. A preliminary study was conducted from June 2015 to February 2016, including 622 patients admitted to the emergency department for infectious syndrome such as /
- Pneumoniae
- Urinary tract infection
- Cellulitis
- Meningitis
- Malaria
- Febrile neutropenia
- Febrile acute diarrhea
- Fever back to the tropics
- Angina
- sexually transmitted infection This prospective study will observe and analyze the adherence of prescribers to these protocols. With description of patients who benefited or not the antibiotic protocol, according to a syndromic approach and analysis of the causes of non-adherence to the protocols. In order to limit the length of stay and reduce the cost of hospitalization..
Detailed description
Consensual antibiotic protocols have been developed and validated locally by infectious disease specialists, internists and emergency physicians, in order to encourage their compliance. A preliminary study was conducted from June 2015 (setting up protocols) to February 2016, including 622 patients admitted to the emergency department for infectious syndrome such as /
- Pneumoniae
- Urinary tract infection
- Cellulitis
- Meningitis
- Malaria
- Febrile neutropenia
- Febrile acute diarrhea
- Fever back to the tropics
- Angina
- sexually transmitted infection This prospective study will observe and analyze the adherence of prescribers to these protocols. With description of patients who benefited or not the antibiotic protocol, according to a syndromic approach and analysis of the causes of non-adherence to the protocols. In order to limit the length of stay and reduce the cost of hospitalization..
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Other: antibiotic protocol, according to a syndromic approach• Patient admitted to emergency for infectious syndrome Description of antibiotic protocol, according to a syndromic approach will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present a infectious syndrom
Key inclusion criteria (3 listed)
- Patient admitted to emergency for infectious syndrome
- Patient > 18 years old.
- Patient who accept to have his medical records reviewed for research.
Key exclusion criteria (1 listed)
- Patient < 18 years old.
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 |
|---|---|---|
| antibiotic protocol, according to a syndromic approachDescription of patients who benefited or not the antibiotic protocol, according to a syndromic approach and analysis of the causes of non-adherence to the protocols | Other | experimental group |
Primary outcome
List of Antibiotic treatment
Time frame: up to 12 weeks
Description of the prescribed antibiotic treatment depending of infectious syndrome: name, duration for each treatment during hospitalization Data will be collected in the medical files: * date of introduction of antibiotic treatment * withdrawal dates * stop dates * antibiotic classes
Adverse events
Time frame: up to 12 weeks
Description of the cause of non adherence to antibiotic treatment initiates at hospital admission of antibiotherapy: Data will be collected in the medical files of patients: events leading to withdrawal or stop treatment (insufficiency renal, allergic reaction ... etc) date of events aggravation or recovery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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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.
EMILIE GARRIDO PRADALIE study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Disease, run by Assistance Publique Hopitaux De Marseille 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 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 17 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PHILIPPE PAROLA, MD (+33 491387235, Philippe.PAROLA@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
List of Antibiotic treatment (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. 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 17 Aug 2018.