Interest of Ascorbic Acid in the Management of Pneumonia in Elderly People Hospitalized.

Pneumonia With Hospitalized Elderly Patient Clinical Trial

— PNEUMO-VITA-C  

Official title:

Interest of Ascorbic Acid in the Management of Pneumonia in Elderly People Hospitalized.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186158
• Other study ID #: CHUBX 2013/09
• Status: Completed
• Phase: Phase 2
• First received: July 4, 2014
• Last updated: September 14, 2016
• Start date: February 2015
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Pneumonia is the second common infection and its risk increases for elderly. In this population, it is the first cause of mortality by infections, and source of many complications. Geriatric studies had shown the high prevalence of ascorbic acid 's deficiency, especially in older hospitalized people. It is well known that vitamin C is one of the key of the immune system, it has a scavenger's role in case of aggression like sepsis. A Cochrane database published in 2013 analyzed the impact of vitamin C for preventing and treating pneumonia. Two randomized studies showed a benefit on respiratory symptoms for patients treated by vitamin C, and for one of those studies it was noted a significant reduction of mortality. The main objective of our study is first to determine the impact on respiratory symptoms of an adjuvant treatment by vitamin C for the management of pneumonia in older people hospitalized, and then evaluate its impact on functional status.

Description:

This study is French non-comparative phase II clinical trial, double-blind randomized, with placebo, single-center. One group would be treated the placebo group, and another would receive an adjuvant treatment by vitamin C : 500 mg twice a day by intra-venous way from the first day to the second included, and then 500 mg twice a day by oral way from the third day to the seventh. For each patient, the study's duration is 7 days, which is the mean stay of hospitalization. During those 7 days, we will make clinical exams and blood tests at d0, d2, d4 and d7. The vitamin C blood level will be measured at d0 and d7.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• people aged = 75 years old

• pneumonia's symptoms according to the SPILF (Société de Pathologie Infectieuse de Langue Française) :

• cough

• at least one respiratory sign : dyspnea, chest pain, wheezing, and local signs at the auscultation

• at least one general sign suggesting an infection : fever, sweat, headache, sore joints, common cold

• pneumonia's symptoms developed between the admission's date in the unit care and the seventh day included

Exclusion Criteria:

• palliative care's patients

• patients with deglutition's disorders

• patients who can't be on a drip

• antibiotherapy since more one day

• other concomitant infection(s)

• patients who can't make their own transfer 15 days ago

• patients who have a NYHA score at IV 15 days ago

• patients with contraindication to a vitamin C treatment : hemochromatosis, oxalo-calcic lithiasis antecedent, G6PD deficit (Glucose 6 Phosphate Dehydrogenase), and treatment by Deferoxamine

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia With Hospitalized Elderly Patient

Intervention

Drug:
• Vitamin C

• Placebo

Locations

Country	Name	City	State
France	CHU de Bordeaux, Hôpital Saint André	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the NYHA score between d-15 and d4 after treatment initiation	The NYHA score d-15 would be noted by medical staff at the inclusion by calling the patient's general practitioner. The NYHA score at d4 will be noted by investigators treating the patient.	4 days after randomisation/treatment initiation	No
Secondary	The NYHA score at d2 and d7		2 and 7 days after randomisation/treament initiation	No
Secondary	Dyspnea's visual analogic scale at d2, d4 and d7		2, 4 and 7 days after randomisation/treament initiation	No
Secondary	Blood saturation without oxygen therapy at d2, d4 and d7		2, 4 and 7 days after randomisation/treament initiation	No
Secondary	Katz's ADL (Activities Daily Living) score at d2,d4 and d7	Katz's ADL will be calculated by medical trained students or doctors at d2, d4 and d7	2, 4 and 7 days after randomisation/treament initiation	No
Secondary	Asthenia's evaluation at d2,d4 and d7		2, 4 and 7 days after randomisation/treament initiation	No
Secondary	Possibility for the patient to make his or her own transfer at d2,d4 and d7		2, 4 and 7 days after randomisation/treament initiation	No
Secondary	Morbidity-mortality at d2,d4 and d7		2, 4 and 7 days after randomisation/treament initiation	Yes
Secondary	Blood inflammation parameters at d2,d4 and d7	Leukocytes and polynuclear neutrophil 's rates, with C-reactive protein will be measured at d2, d4 and d7	2, 4 and 7 days after randomisation/treament initiation	No
Secondary	Vitamin C blood level at d7		7 days after randomisation/treament initiation	No