Patients Receiving Antimicrobial TherapyATBREFSURMEDNCT01136200
Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Surgical and Medical Wards
A study testing Infectious disease specialist advice in people with Patients Receiving Antimicrobial Therapy, run by Henri Mondor University Hospital at 1 site in France.
Trial summary
CONTEXT: Antibiotics are frequently used in hospital but the appropriateness of prescriptions ranged between 25-50%. The intervention of infectious disease specialists (IDS) could improve the appropriateness of prescriptions and reduce their use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Receiving Antimicrobial Therapy
- What is being tested?
- Infectious disease specialist advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Oct 2011
- 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
- Adults
- Hospitalized in surgical or medical wards
- Receiving antimicrobial therapy for active infection or prolonged surgical prophylaxis
- Therapy prescribed by the attending ward physician
Who cannot join
- Patients receiving antimicrobial therapy not prescribed by the attending ward physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Surgical and Medical Wards: a Multicenter Randomized Controlled Trial.
CONTEXT: Antibiotics are frequently used in hospital but the appropriateness of prescriptions ranged between 25-50%. The intervention of infectious disease specialists (IDS) could improve the appropriateness of prescriptions and reduce their use. The impact of IDS has not been yet fully estimated using a randomized trial to compare the quality of care of patients who will benefit of the intervention.
OBJECTIVES: To show using a randomized trial that patients with IDS advice will receive more appropriate antimicrobial therapy but less exposure to antibiotics, as compared to patients who will not receive IDS advice.
Read more
METHODS: Prospective randomized trial comparing antibiotic exposure and appropriateness of prescriptions in two groups of patients:
- Control group: antibiotic prescriptions will be initiated and managed by the attending physicians
- Intervention group: antibiotic prescriptions will be systematically evaluated by the IDS and changed if judged necessary by the attending physicians, following IDS' advice.
STUDY PROCESS: The study will took place in 4 university hospitals. Two medical or surgical wards will participate by hospital. For each ward, the period of the study will be 2 x 4 weeks.Total duration of the study: 12 months.
- Conditions
- Patients Receiving Antimicrobial Therapy
- Being tested
- Infectious disease specialist advice
- Keywords
- Surgical and medical wards, Adults, Antimicrobial therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infectious disease specialist adviceOther
Indication, choice, dosing and duration of antimicrobial therapy
| Study group | Role | What they receive |
|---|---|---|
| Infectious disease specialist advice | Experimental | Patients receiving the intervention (infectious disease specialist advice) Receives: Other: Infectious disease specialist advice |
| Control | No intervention | Patients not receiving infectious disease specialist advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriateness of antimicrobial therapy
Appropriateness of antimicrobial therapy will be evaluated at the start, between days 3 and 5, and at the end of therapy (between days 7 and 10).
Measured: Between days 7 and 10 after starting antimicrobial therapy
Secondary outcomes (2)
Clinical impact
Length of hospitalization;clinical outcome: resolution of infection; in hospital mortality
Measured: Between days 7 and 10 after starting antimicrobial therapy
Antibiotic exposure
Antibiotic exposure will be evaluated using the following parameters:
number of days of therapy/numbers of days of hospitalization; defined daily doses of antibiotic/number of days of hospitalization
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2011
- Study completionOct 2011
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 Patients Receiving Antimicrobial TherapyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henri Mondor University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe LESPRIT, Henri Mondor University Hospital
- Investigators
- Philippe Lesprit, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136200
- Sponsor's protocol ID
- PREQHOS 08023
- Acronym
- ATBREFSURMED
- Status last verified
- Jul 2014
- First submitted
- 28 May 2010
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lesprit P, de Pontfarcy A, Esposito-Farese M, Ferrand H, Mainardi JL, Lafaurie M, Parize P, Rioux C, Tubach F, Lucet JC. Postprescription review improves in-hospital antibiotic use: a multicenter randomized controlled trial. Clin Microbiol Infect. 2015 Feb;21(2):180.e1-7. doi: 10.1016/j.cmi.2014.08.015. Epub 2014 Oct 14.
PubMed 25658564
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Surgical and Medical Wards: a Multicenter Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01136200
- Acronym / sponsor ID
- ATBREFSURMED / PREQHOS 08023
- Conditions
- Patients Receiving Antimicrobial Therapy
- Keywords
- Surgical and medical wards, Adults, Antimicrobial therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Henri Mondor University HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 3 Jun 2010 (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.
CONTEXT: Antibiotics are frequently used in hospital but the appropriateness of prescriptions ranged between 25-50%. The intervention of infectious disease specialists (IDS) could improve the appropriateness of prescriptions and reduce their use. The impact of IDS has not been yet fully estimated using a randomized trial to compare the quality of care of patients who will benefit of the intervention.
OBJECTIVES: To show using a randomized trial that patients with IDS advice will receive more appropriate antimicrobial therapy but less exposure to antibiotics, as compared to patients who will not receive IDS advice.
METHODS: Prospective randomized trial comparing antibiotic exposure and appropriateness of prescriptions in two groups of patients:
- Control group: antibiotic prescriptions will be initiated and managed by the attending physicians
- Intervention group: antibiotic prescriptions will be systematically evaluated by the IDS and changed if judged necessary by the attending physicians, following IDS' advice.
STUDY PROCESS: The study will took place in 4 university hospitals. Two medical or surgical wards will participate by hospital. For each ward, the period of the study will be 2 x 4 weeks.Total duration of the study: 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infectious disease specialist advice | Experimental | Other: Infectious disease specialist advicePatients receiving the intervention (infectious disease specialist advice) |
| Control | No intervention | –Patients not receiving infectious disease specialist advice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults
- Hospitalized in surgical or medical wards
- Receiving antimicrobial therapy for active infection or prolonged surgical prophylaxis
- Therapy prescribed by the attending ward physician
Key exclusion criteria (1 listed)
- Patients receiving antimicrobial therapy not prescribed by the attending ward physician
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 |
|---|---|---|
| Infectious disease specialist adviceIndication, choice, dosing and duration of antimicrobial therapy | Other | Infectious disease specialist advice |
Primary outcome
Appropriateness of antimicrobial therapy
Time frame: Between days 7 and 10 after starting antimicrobial therapy
Appropriateness of antimicrobial therapy will be evaluated at the start, between days 3 and 5, and at the end of therapy (between days 7 and 10).
2 secondary outcomes
Clinical impact
Time frame: Between days 7 and 10 after starting antimicrobial therapy
Antibiotic exposure
Time frame: 14 days
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 29 Jul 2014.
- Derived from this study: PubMed 25658564Lesprit P, de Pontfarcy A, Esposito-Farese M, Ferrand H, Mainardi JL, Lafaurie M, Parize P, Rioux C, Tubach F, Lucet JC. Postprescription review improves in-hospital antibiotic use: a multicenter randomized controlled trial. Clin Microbiol Infect. 2015 Feb;21(2):180.e1-7. doi: 10.1016/j.cmi.2014.08.015. Epub 2014 Oct 14.
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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.
Philippe Lesprit, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infectious disease specialist advice in people with Patients Receiving Antimicrobial Therapy, run by Henri Mondor University Hospital 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 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: finished, as of the sponsor's last update on 29 Jul 2014. 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 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?
Appropriateness of antimicrobial therapy (time frame: Between days 7 and 10 after starting antimicrobial therapy). 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 NCT01136200, 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 29 Jul 2014.