<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02186158</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2013/09</org_study_id>
    <nct_id>NCT02186158</nct_id>
  </id_info>
  <brief_title>Interest of Ascorbic Acid in the Management of Pneumonia in Elderly People Hospitalized.</brief_title>
  <acronym>PNEUMO-VITA-C</acronym>
  <official_title>Interest of Ascorbic Acid in the Management of Pneumonia in Elderly People Hospitalized.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pneumonia is the second common infection and its risk increases for elderly. In this&#xD;
      population, it is the first cause of mortality by infections, and source of many&#xD;
      complications. Geriatric studies had shown the high prevalence of ascorbic acid 's&#xD;
      deficiency, especially in older hospitalized people. It is well known that vitamin C is one&#xD;
      of the key of the immune system, it has a scavenger's role in case of aggression like sepsis.&#xD;
      A Cochrane database published in 2013 analyzed the impact of vitamin C for preventing and&#xD;
      treating pneumonia. Two randomized studies showed a benefit on respiratory symptoms for&#xD;
      patients treated by vitamin C, and for one of those studies it was noted a significant&#xD;
      reduction of mortality. The main objective of our study is first to determine the impact on&#xD;
      respiratory symptoms of an adjuvant treatment by vitamin C for the management of pneumonia in&#xD;
      older people hospitalized, and then evaluate its impact on functional status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is French non-comparative phase II clinical trial, double-blind randomized, with&#xD;
      placebo, single-center. One group would be treated the placebo group, and another would&#xD;
      receive an adjuvant treatment by vitamin C : 500 mg twice a day by intra-venous way from the&#xD;
      first day to the second included, and then 500 mg twice a day by oral way from the third day&#xD;
      to the seventh. For each patient, the study's duration is 7 days, which is the mean stay of&#xD;
      hospitalization. During those 7 days, we will make clinical exams and blood tests at d0, d2,&#xD;
      d4 and d7. The vitamin C blood level will be measured at d0 and d7.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in the NYHA score between d-15 and d4 after treatment initiation</measure>
    <time_frame>4 days after randomisation/treatment initiation</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The NYHA score at d2 and d7</measure>
    <time_frame>2 and 7 days after randomisation/treament initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnea's visual analogic scale at d2, d4 and d7</measure>
    <time_frame>2, 4 and 7 days after randomisation/treament initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood saturation without oxygen therapy at d2, d4 and d7</measure>
    <time_frame>2, 4 and 7 days after randomisation/treament initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Katz's ADL (Activities Daily Living) score at d2,d4 and d7</measure>
    <time_frame>2, 4 and 7 days after randomisation/treament initiation</time_frame>
    <description>Katz's ADL will be calculated by medical trained students or doctors at d2, d4 and d7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthenia's evaluation at d2,d4 and d7</measure>
    <time_frame>2, 4 and 7 days after randomisation/treament initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Possibility for the patient to make his or her own transfer at d2,d4 and d7</measure>
    <time_frame>2, 4 and 7 days after randomisation/treament initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity-mortality at d2,d4 and d7</measure>
    <time_frame>2, 4 and 7 days after randomisation/treament initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood inflammation parameters at d2,d4 and d7</measure>
    <time_frame>2, 4 and 7 days after randomisation/treament initiation</time_frame>
    <description>Leukocytes and polynuclear neutrophil 's rates, with C-reactive protein will be measured at d2, d4 and d7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin C blood level at d7</measure>
    <time_frame>7 days after randomisation/treament initiation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Pneumonia With Hospitalized Elderly Patient</condition>
  <arm_group>
    <arm_group_label>Vitamin C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin C</intervention_name>
    <arm_group_label>Vitamin C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  people aged ≥ 75 years old&#xD;
&#xD;
          -  pneumonia's symptoms according to the SPILF (Société de Pathologie Infectieuse de&#xD;
             Langue Française) :&#xD;
&#xD;
               -  cough&#xD;
&#xD;
               -  at least one respiratory sign : dyspnea, chest pain, wheezing, and local signs at&#xD;
                  the auscultation&#xD;
&#xD;
               -  at least one general sign suggesting an infection : fever, sweat, headache, sore&#xD;
                  joints, common cold&#xD;
&#xD;
          -  pneumonia's symptoms developed between the admission's date in the unit care and the&#xD;
             seventh day included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  palliative care's patients&#xD;
&#xD;
          -  patients with deglutition's disorders&#xD;
&#xD;
          -  patients who can't be on a drip&#xD;
&#xD;
          -  antibiotherapy since more one day&#xD;
&#xD;
          -  other concomitant infection(s)&#xD;
&#xD;
          -  patients who can't make their own transfer 15 days ago&#xD;
&#xD;
          -  patients who have a NYHA score at IV 15 days ago&#xD;
&#xD;
          -  patients with contraindication to a vitamin C treatment : hemochromatosis,&#xD;
             oxalo-calcic lithiasis antecedent, G6PD deficit (Glucose 6 Phosphate Dehydrogenase),&#xD;
             and treatment by Deferoxamine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aurélie LAFARGUE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Bordeaux (France)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Antoine BENARD, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Bordeaux (France)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Bordeaux, Hôpital Saint André</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>September 14, 2016</last_update_submitted>
  <last_update_submitted_qc>September 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pneumonia</keyword>
  <keyword>Elderly</keyword>
  <keyword>Ascorbic acid</keyword>
  <keyword>Vitamin C</keyword>
  <keyword>Hospitalized patient</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02186158
org study id: CHUBX 2013/09
nct id: NCT02186158
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Difference in the NYHA score between d-15 and d4 after treatment initiation
time frame: 4 days after randomisation/treatment initiation
description: 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.
measure: The NYHA score at d2 and d7
time frame: 2 and 7 days after randomisation/treament initiation
measure: Dyspnea's visual analogic scale at d2, d4 and d7
time frame: 2, 4 and 7 days after randomisation/treament initiation
measure: Blood saturation without oxygen therapy at d2, d4 and d7
time frame: 2, 4 and 7 days after randomisation/treament initiation
measure: Katz's ADL (Activities Daily Living) score at d2,d4 and d7
time frame: 2, 4 and 7 days after randomisation/treament initiation
description: Katz's ADL will be calculated by medical trained students or doctors at d2, d4 and d7
measure: Asthenia's evaluation at d2,d4 and d7
time frame: 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
time frame: 2, 4 and 7 days after randomisation/treament initiation
measure: Morbidity-mortality at d2,d4 and d7
time frame: 2, 4 and 7 days after randomisation/treament initiation
measure: Blood inflammation parameters at d2,d4 and d7
time frame: 2, 4 and 7 days after randomisation/treament initiation
description: Leukocytes and polynuclear neutrophil 's rates, with C-reactive protein will be measured at d2, d4 and d7
measure: Vitamin C blood level at d7
time frame: 7 days after randomisation/treament initiation
arm group label: Vitamin C
arm group type: Experimental
description: 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.
arm group label: Placebo
arm group type: Placebo Comparator
description: 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.
intervention type: Drug
intervention name: Vitamin C
arm group label: Vitamin C
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Aurélie LAFARGUE, MD
role: Principal Investigator
affiliation: University Hospital Bordeaux (France)
last name: Antoine BENARD, MD
role: Study Chair
affiliation: University Hospital Bordeaux (France)
facility: 
country: France
responsible party type: Sponsor
mesh term: Pneumonia