NCT00561210

Brief Summary

Compare clinical and biological effects of two enteral tube feeding nutrition formula (immune enhancing diet versus polymeric diet)in severe burn hospitalized patients .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2003

Longer than P75 for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

6.3 years

First QC Date

November 16, 2007

Last Update Submit

November 18, 2013

Conditions

Infections onSevere Burn Patients

Keywords

infections

Outcome Measures

Primary Outcomes (1)

  • Number of infections and number of multiple organ failure

    6 months

Secondary Outcomes (1)

  • digestive tolerance and healing

    6 months

Study Arms (2)

I

EXPERIMENTAL

Total enteral tube feeding

Dietary Supplement: Crucial

II

ACTIVE COMPARATOR

Total enteral tube feeding

Dietary Supplement: Sondalis HP

Interventions

CrucialDIETARY_SUPPLEMENT

Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.

I
Sondalis HPDIETARY_SUPPLEMENT

Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.

II

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Thermic burn from 20% to 80%
  • \< age \< 70 years
  • written informed consent

You may not qualify if:

  • diabetes mellitus
  • corticoid or immuno-suppressive therapy
  • HIV
  • evolutive cancers
  • pregnancy
  • abdominal lesion
  • hepatic or renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU Pellegrin-Unites des brules

Bordeaux, 33076, France

Location

Hôpital Saint Luc - Service des brûlés

Lyon, 69009, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

Hopital Hotel Dieu-Service des brules

Nantes, 44093, France

Location

Hopital Saint Antoine- Service des Brules

Paris, 75571, France

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Cecile Chambrier

    Hopital Edouard Herriot - Lyon

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2007

First Posted

November 20, 2007

Study Start

November 1, 2003

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations

FR(5)