Infections onPhase 4NCT00561210
Effect of Early Enteral Tube Feeding Nutrition With an Immune Enhancing Diet in Severe Burn Patients
A Phase 4 study testing Crucial and Sondalis HP in people with Infections on and Severe Burn Patients, run by Société des Produits Nestlé (SPN) at 5 sites in France.
Trial summary
Compare clinical and biological effects of two enteral tube feeding nutrition formula (immune enhancing diet versus polymeric diet)in severe burn hospitalized patients . Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Infections on, Severe Burn Patients
- What is being tested?
- Crucial and Sondalis HP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 5 sitesFrance
- Study dates
- Nov 2003to Mar 2010
- Phase
- Phase 4
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Thermic burn from 20% to 80%
- 15 < age < 70 years
- written informed consent
Who cannot join
- diabetes mellitus
- corticoid or immuno-suppressive therapy
- HIV
- evolutive cancers
- pregnancy
- abdominal lesion
- hepatic or renal failure
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Pellegrin-Unites des brules
Bordeaux, 33076
Hôpital Saint Luc - Service des brûlés
Lyon, 69009
Hôpital Edouard Herriot
Lyon, 69437
Hopital Hotel Dieu-Service des brules
Nantes, 44093
Hopital Saint Antoine- Service des Brules
Paris, 75571
About this study
Compare clinical and biological effects of two enteral tube feeding nutrition formula (immune enhancing diet versus polymeric diet)in severe burn hospitalized patients .
- Conditions
- Infections on, Severe Burn Patients
- Being tested
- Crucial, Sondalis HP
- Keywords
- infections
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrucialDietary supplement
Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.
Sondalis HPDietary supplement
Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Total enteral tube feeding Receives: Dietary Supplement: Crucial |
| II | Active comparator | Total enteral tube feeding Receives: Dietary Supplement: Sondalis HP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of infections and number of multiple organ failure
Measured: 6 months
Secondary outcomes (1)
digestive tolerance and healing
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startNov 2003
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections onStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cecile Chambrier, Study chair, Hopital Edouard Herriot - Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561210
- Sponsor's protocol ID
- NCNF 0501
- Status last verified
- Nov 2013
- First submitted
- 16 Nov 2007
- Last updated
- 19 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Enteral Tube Feeding Nutrition With an Immune Enhancing Diet in Severe Burn Patients
- ClinicalTrials.gov ID
- NCT00561210
- Acronym / sponsor ID
- NCNF 0501
- Conditions
- Infections on, Severe Burn Patients
- Keywords
- infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 20 Nov 2007 (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.
Compare clinical and biological effects of two enteral tube feeding nutrition formula (immune enhancing diet versus polymeric diet)in severe burn hospitalized patients .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Dietary Supplement: CrucialTotal enteral tube feeding |
| II | Active comparator | Dietary Supplement: Sondalis HPTotal enteral tube feeding |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Thermic burn from 20% to 80%
- 15 < age < 70 years
- written informed consent
Key exclusion criteria (7 listed)
- diabetes mellitus
- corticoid or immuno-suppressive therapy
- HIV
- evolutive cancers
- pregnancy
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 |
|---|---|---|
| CrucialTreatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI. | Dietary supplement | I |
| Sondalis HPTreatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI. | Dietary supplement | II |
Primary outcome
Number of infections and number of multiple organ failure
Time frame: 6 months
1 secondary outcome
digestive tolerance and healing
Time frame: 6 months
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 19 Nov 2013.
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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.
Cecile Chambrier study chair
Hopital Edouard Herriot - Lyon
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Crucial and Sondalis HP in people with Infections on and Severe Burn Patients, run by Société des Produits Nestlé (SPN) at 5 sites 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 7 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 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 infections and number of multiple organ failure (time frame: 6 months). 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 19 Nov 2013.