Clinical trial NCT02186158: Interest of Ascorbic Acid in the Management of Pneumonia in Elderly People Hospitalized.
Official title: Interest of Ascorbic Acid in the Management of Pneumonia in Elderly People Hospitalized.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumonia With Hospitalized Elderly Patient
Keywords: Pneumonia
Elderly
Ascorbic acid
Vitamin C
Hospitalized patient
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 9
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Difference in the NYHA score between d-15 and d4 after treatment initiation
timeFrame: 4 days after randomisation/treatment initiation
Secondary outcomes:
measure: The NYHA score at d2 and d7
timeFrame: 2 and 7 days after randomisation/treament initiation
measure: Dyspnea's visual analogic scale at d2, d4 and d7
timeFrame: 2, 4 and 7 days after randomisation/treament initiation
measure: Blood saturation without oxygen therapy at d2, d4 and d7
timeFrame: 2, 4 and 7 days after randomisation/treament initiation
measure: Katz's ADL (Activities Daily Living) score at d2,d4 and d7
timeFrame: 2, 4 and 7 days after randomisation/treament initiation
measure: Asthenia's evaluation at d2,d4 and d7
timeFrame: 2, 4 and 7 days after randomisation/treament initiation
measure: Possibility for the patient to make his or her own transfer at d2,d4 and d7
timeFrame: 2, 4 and 7 days after randomisation/treament initiation
measure: Morbidity-mortality at d2,d4 and d7
timeFrame: 2, 4 and 7 days after randomisation/treament initiation
measure: Blood inflammation parameters at d2,d4 and d7
timeFrame: 2, 4 and 7 days after randomisation/treament initiation
measure: Vitamin C blood level at d7
timeFrame: 7 days after randomisation/treament initiation
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux, Hôpital Saint André
Study officials:
affiliation: University Hospital Bordeaux (France)
name: Aurélie LAFARGUE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Bordeaux (France)
name: Antoine BENARD, MD
role: STUDY_CHAIR
References: