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

NCT ID: NCT02186158

Last Updated: 2016-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-05-31

Brief 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.

Detailed 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.

Conditions

Pneumonia With Hospitalized Elderly Patient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vitamin C

Each patient of this group will be received a direct intravenous injection of 2,5 ml ascorbic acid twice a day (at the morning and the lunchtime) from d1 to d2 included. From d3 to d7 included, ascorbic acid's capsules produced by the University Hospital Bordeaux's central pharmacy to keep the double blind way of this study will be given at patient at the morning and at the lunchtime.

Group Type: EXPERIMENTAL

Vitamin C

Intervention Type: DRUG

Placebo

Each patient of this group will be received a direct intravenous injection of 2,5 ml NaCl 9% twice a day (at the morning and the lunchtime) from d1 to d2 included. From d3 to d7 included, mannitol's capsules produced by the University Hospital Bordeaux's central pharmacy will be given at patient at the morning and at the lunchtime.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Vitamin C

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurélie LAFARGUE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bordeaux (France)

Antoine BENARD, MD

Role: STUDY_CHAIR

University Hospital Bordeaux (France)

Locations

CHU de Bordeaux, Hôpital Saint André

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2013/09

Identifier Type: -

Identifier Source: org_study_id