Safety and efficacy of subcutaneous (SC) administration of Clinimix N9G15E in elderly patients at risk for malnutrition, at a dose of 1 liter infused over 12 hours for 7 to 10 consecutive days. A prospective, multicentre, randomized, open-label, non-inferiority, controlled phase III B trial carried out in parallel groups: subcutaneous versus peripheral intravenous administration.

Phase 1

• Conditions: The population studied will be the elderly population at risk for malnutrition without any predefined pathology at hospital geriatrician wards.; MedDRA version: 9.1 Level: PT Classification code 10051284 Term: Parenteral nutrition

• Registration Number: EUCTR2007-006153-31-FR
• Lead Sponsor: Baxter R and D Europe SCR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-11
• Study Completion: 2010-04-09
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

1. Both genders
2. Age superior or equal to 65 years
3. Hospitalized and at risk for malnutrition defined by their MNA SF below 12 and GNRI between 83.5 and 97.5.
4. Oral intake < 50% of appropriate intake (defined as 30 Kcal/kg/day) for an expected duration of greater than 3 days. Severe dehydrated patients must be rehydrated before enrolling into the trial
5. Dated and signed written informed consent, prior to any study-related procedures, provided by the patient or, according to the law (L. 1122-2), by his legal representative or by a personne de confiance” if any written designation or, if not, his family member or, if no family member, a close relative
6. Patients in stable condition
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Malnutrition requiring tube feeding or parenteral nutrition when admitted to study. Parenteral nutrition includes use of glucose 10% or greater and amino acid solutions
2. Severe cardiac failure or serious cardiovascular compromise
3.Patients receiving therapeutic anticoagulation
4. Patients with coagulopathies (platelet count < 100,000; Pt or PTT > 1.5 normal)
5. Severe burns or other diffuse skin diseases on site of the the infusion administration
6. Patient with decubitus ulcers greater than grade 2 (NPUAP classification)
7. Patient with an inflammatory syndrome defined by a CRP >50 mg/L
8. Severe Renal failure
9. Known hypersensitivity to components of Clinimix N9G15E
10. Unconsciousness
11. Not expected to survive for a minimum of 3 weeks
12. Known congenital abnormalities of amino acid metabolism
13. Severe uncontrolled hyperglycemia
14. Severe electrolyte disorders precluding administration of Na, K, Ca, Mg, PO4
15. Patients taking part already in this study
16. Patients taking part in any other clinical trials within 2 months
17. Patients who have received Clinimix N9G15E or any other amino acid solution within the 10 previous days by any administration routes
18. Confined persons and prisoners
19. Patients with any other clinically significant disease or clinically significant finding, which, at the discretion of the investigator, would expose the patient to an increased risk of a significant adverse event or would interfere with the assessments of efficacy or safety during the course of the study
20.Patients with a history of or physical examination findings indicative of active alcohol or drug abuse
21. Known HIV positivity
22. Patients without affiliation to the French Sécurité Sociale

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To show the non-inferiority of subcutaneously versus intravenously administered Clinimix N9G15E 1 L, upon major local side effects defined as large edema, blistering, phlebitis, cellulitis, erythema (diameter > 10 cm) and strong pain.;Secondary Objective: To assess the safety and the efficacy of Clinimix N9G15E administered subcutaneously versus intravenously upon patient nutritional parameters, clinical outcomes and hydration status.;Primary end point(s): Major local side effects defined as large edema (diameter > 10 cm), blistering(diameter > 2 cm), erythema (diameter > 10 cm), phlebitis, cellulitis, and strong pain.