CatheterizationSepti-PICCNCT02899546
Study of Peripherally Inserted Central Catheter (PICC)-Related Infections in a Tropical Area
An observational study of Catheterization and Peripheral, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial summary
Septi-PICC study aims at assessing incidence of Peripherally Inserted Central Catheter (PICC)-related infections among patients managed in the University Hospital of La Reunion for PICC setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheterization, Peripheral, Infection
- How many people
- 283 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2015to 30 Oct 2016
- 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: All patients managed for a PICC setting in the tertiary care hospital
Who may be able to join
- all patients managed for a PICC setting in the tertiary care hospital
Who cannot join
- known pregnancy
- minor
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de La Réunion
Saint-Pierre, 97448
About this study
Official title: Suivi Prospectif Des Complications Infectieuses liées Aux PICC Lines en Milieu Tropical
Septi-PICC study aims at assessing incidence of Peripherally Inserted Central Catheter (PICC)-related infections among patients managed in the University Hospital of La Reunion for PICC setting.
Read the detailed description
Septi-PICC is a prospective single-center study of infections related to PICCs setting at the South tertiary site of the University Hospital of La Reunion over one year with a follow-up of 6 months per patient.
All the complications such as thromboembolic, are collected during the follow-up.
It is planned a convenience sample of 400 patients over 18 years of age, except pregnant women.
- Conditions
- Catheterization, Peripheral, Infection
- Keywords
- Peripherally Inserted Central Catheter, Infections, Radiology
- Medical subject headings
- Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PICC-related infections
Measured: 1 year with 6 months follow-up
Secondary outcomes (2)
Incidence of other complications following the PICC setting
Measured: 6 months follow-up
Incidence of hospitalizations following the PICC setting
Measured: 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start1 Nov 2015
- Primary completion30 Oct 2016
- Study completion30 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CatheterizationStudies 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
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899546
- Sponsor's protocol ID
- 2014/CHU/Septi-PICC
- Acronym
- Septi-PICC
- Status last verified
- Sep 2018
- First submitted
- 7 Sep 2016
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suivi Prospectif Des Complications Infectieuses liées Aux PICC Lines en Milieu Tropical
- ClinicalTrials.gov ID
- NCT02899546
- Acronym / sponsor ID
- Septi-PICC / 2014/CHU/Septi-PICC
- Conditions
- Catheterization, Peripheral, Infection
- Keywords
- Peripherally Inserted Central Catheter, Infections, Radiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 30 Oct 2016 (actual)
- First posted
- 14 Sep 2016 (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.
Septi-PICC study aims at assessing incidence of Peripherally Inserted Central Catheter (PICC)-related infections among patients managed in the University Hospital of La Reunion for PICC setting.
Detailed description
Septi-PICC is a prospective single-center study of infections related to PICCs setting at the South tertiary site of the University Hospital of La Reunion over one year with a follow-up of 6 months per patient.
All the complications such as thromboembolic, are collected during the follow-up.
It is planned a convenience sample of 400 patients over 18 years of age, except pregnant women.
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
- All patients managed for a PICC setting in the tertiary care hospital
Key inclusion criteria (1 listed)
- all patients managed for a PICC setting in the tertiary care hospital
Key exclusion criteria (2 listed)
- known pregnancy
- minor
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
Incidence of PICC-related infections
Time frame: 1 year with 6 months follow-up
2 secondary outcomes
Incidence of other complications following the PICC setting
Time frame: 6 months follow-up
Incidence of hospitalizations following the PICC setting
Time frame: 6 months follow-up
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 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Catheterization and Peripheral, run by Centre Hospitalier Universitaire de la Réunion 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 1 inclusion and 2 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 Sep 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?
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?
Incidence of PICC-related infections (time frame: 1 year with 6 months follow-up). 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 Sep 2018.