Acute Infectious DiseasesNCT03329768
Evaluation of Medical Device
An observational study of Acute Infectious Diseases, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
A preliminary study was conducted from 01/26/2015 to 10/26/2015 on 605 patients admitted to MIA with an intravenous and/or a urinary catheter. the investigators analyzed: the demographic characteristics of the patient the final diagnosis the patient's severity and the patient outcome after discharge from MIA the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Infectious Diseases
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- 28 Sep 2016to 2 Jun 2023
- 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: Patient with an intravenous and/or urinary catheter on admission in the department of "Maladies infectieuses aigues" (MIA) Hopital de la Timone AP-HM.
Who may be able to join
- Patient with an intravenous catheter and/or a urinary catheter.
- Patient is more than 18 years old.
- Patient who accepts to have his medical records reviewed for research.
- Patient with health insurance
Who cannot join
- Refusal of participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Peripheral Intravenous Catheter and Urinary Catheters Present on Admission to the "Maladies Infectieuses aiguës" Department.
A preliminary study was conducted from 01/26/2015 to 10/26/2015 on 605 patients admitted to MIA with an intravenous and/or a urinary catheter.
the investigators analyzed:
Read more
- the demographic characteristics of the patient
- the final diagnosis
- the patient's severity and the patient outcome after discharge from MIA
- the justification of the venous and or a urinary catheter
- the duration of the prescription of the device Evaluation on admission of the need to maintain an intravenous or urinary catheter. Adjusting the prescription in terms of duration or withdrawal of the device in order to limit their complications (lymphangitis, superficial thrombophlebitis, bacteremia related to health care, urinary tract infection).
Hypothesis:
Limit the length of stay and reduce the cost of hospitalization.
- Conditions
- Acute Infectious Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with intravenous catheter
Measured: 3 YEARS
number of patients with urinary catheter
Measured: 3 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start28 Sep 2016
- Primary completion25 Jan 2020
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Infectious DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jean-olivier ARNAUD, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329768
- Sponsor's protocol ID
- 2016-15
- Other IDs
- 2016-A00673-48
- Status last verified
- Jun 2023
- First submitted
- 25 Oct 2017
- Last updated
- 5 Jun 2023
- 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 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Peripheral Intravenous Catheter and Urinary Catheters Present on Admission to the "Maladies Infectieuses aiguës" Department.
- ClinicalTrials.gov ID
- NCT03329768
- Acronym / sponsor ID
- 2016-15
- Conditions
- Acute Infectious Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 28 Sep 2016 (actual)
- Primary completion
- 25 Jan 2020 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 6 Nov 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.
A preliminary study was conducted from 01/26/2015 to 10/26/2015 on 605 patients admitted to MIA with an intravenous and/or a urinary catheter.
the investigators analyzed:
- the demographic characteristics of the patient
- the final diagnosis
- the patient's severity and the patient outcome after discharge from MIA
- the justification of the venous and or a urinary catheter
- the duration of the prescription of the device Evaluation on admission of the need to maintain an intravenous or urinary catheter. Adjusting the prescription in terms of duration or withdrawal of the device in order to limit their complications (lymphangitis, superficial thrombophlebitis, bacteremia related to health care, urinary tract infection).
Hypothesis:
Limit the length of stay and reduce the cost of hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with an intravenous and/or urinary catheter on admission in the department of "Maladies infectieuses aigues" (MIA) Hopital de la Timone AP-HM.
Key inclusion criteria (4 listed)
- Patient with an intravenous catheter and/or a urinary catheter.
- Patient is more than 18 years old.
- Patient who accepts to have his medical records reviewed for research.
- Patient with health insurance
Key exclusion criteria (1 listed)
- Refusal of participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of patients with intravenous catheter
Time frame: 3 YEARS
number of patients with urinary catheter
Time frame: 3 YEARS
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 5 Jun 2023.
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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.
jean-olivier ARNAUD study director
Assistance Publique Hopitaux De Marseille
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 Acute Infectious Diseases, 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 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 5 Jun 2023. 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?
number of patients with intravenous catheter (time frame: 3 YEARS). 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 5 Jun 2023.