Pneumonia With Hospitalized Elderly Patient
Conditions
Keywords
Pneumonia, Elderly, Ascorbic acid, Vitamin C, Hospitalized patient
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.
Interventions
DRUGVitamin C
DRUGPlacebo
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the NYHA score between d-15 and d4 after treatment initiation | 4 days after randomisation/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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The NYHA score at d2 and d7 | 2 and 7 days after randomisation/treament initiation | — |
| Dyspnea's visual analogic scale at d2, d4 and d7 | 2, 4 and 7 days after randomisation/treament initiation | — |
| Blood saturation without oxygen therapy at d2, d4 and d7 | 2, 4 and 7 days after randomisation/treament initiation | — |
| Katz's ADL (Activities Daily Living) score at d2,d4 and d7 | 2, 4 and 7 days after randomisation/treament initiation | Katz's ADL will be calculated by medical trained students or doctors at d2, d4 and d7 |
| Asthenia's evaluation at d2,d4 and d7 | 2, 4 and 7 days after randomisation/treament initiation | — |
| 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 | — |
| Morbidity-mortality at d2,d4 and d7 | 2, 4 and 7 days after randomisation/treament initiation | — |
| Blood inflammation parameters at d2,d4 and d7 | 2, 4 and 7 days after randomisation/treament initiation | Leukocytes and polynuclear neutrophil 's rates, with C-reactive protein will be measured at d2, d4 and d7 |
| Vitamin C blood level at d7 | 7 days after randomisation/treament initiation | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAurélie LAFARGUE, MD
University Hospital Bordeaux (France)
STUDY_CHAIRAntoine BENARD, MD
University Hospital Bordeaux (France)
Outcome results
None listed