Pneumonia With Hospitalized Elderly PatientPhase 2PNEUMO-VITA-CNCT02186158
Interest of Ascorbic Acid in the Management of Pneumonia in Elderly People Hospitalized.
A Phase 2 study testing Vitamin C in people with Pneumonia With Hospitalized Elderly Patient, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Pneumonia With Hospitalized Elderly Patient
- What is being tested?
- Vitamin C
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Vitamin C, Placebo
- Keywords
- Pneumonia, Elderly, Ascorbic acid, Vitamin C, Hospitalized patient
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C | Experimental | 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. Receives: Drug: Vitamin C |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 days after randomisation/treatment initiation
Secondary outcomes (9)
The NYHA score at d2 and d7
Measured: 2 and 7 days after randomisation/treament initiation
Dyspnea's visual analogic scale at d2, d4 and d7
Measured: 2, 4 and 7 days after randomisation/treament initiation
Blood saturation without oxygen therapy at d2, d4 and d7
Measured: 2, 4 and 7 days after randomisation/treament initiation
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
Measured: 2, 4 and 7 days after randomisation/treament initiation
Asthenia's evaluation at d2,d4 and d7
Measured: 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
Measured: 2, 4 and 7 days after randomisation/treament initiation
Morbidity-mortality at d2,d4 and d7
Measured: 2, 4 and 7 days after randomisation/treament initiation
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
Measured: 2, 4 and 7 days after randomisation/treament initiation
Vitamin C blood level at d7
Measured: 7 days after randomisation/treament initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startFeb 2015
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: target number of inclusion not reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia With Hospitalized Elderly PatientStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélie LAFARGUE, MD, Principal investigator, University Hospital Bordeaux (France)Antoine BENARD, MD, Study chair, University Hospital Bordeaux (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186158
- Sponsor's protocol ID
- CHUBX 2013/09
- Other IDs
- 2014-000788-42, 2014
- Acronym
- PNEUMO-VITA-C
- Status last verified
- Sep 2016
- First submitted
- 4 Jul 2014
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Ascorbic Acid in the Management of Pneumonia in Elderly People Hospitalized.
- ClinicalTrials.gov ID
- NCT02186158
- Acronym / sponsor ID
- PNEUMO-VITA-C / CHUBX 2013/09
- Keywords
- Pneumonia, Elderly, Ascorbic acid, Vitamin C, Hospitalized patient
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: target number of inclusion not reached
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin C | Experimental | Drug: Vitamin CEach 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. |
| Placebo | Placebo comparator | Drug: PlaceboEach 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- people aged ≥ 75 years old
- pneumonia's symptoms according to the SPILF (Société de Pathologie Infectieuse de Langue Française) :
- pneumonia's symptoms developed between the admission's date in the unit care and the seventh day included
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C | Drug | Vitamin C |
| Placebo | Drug | Placebo |
Primary outcome
Difference in the NYHA score between d-15 and d4 after treatment initiation
Time frame: 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.
9 secondary outcomes
The NYHA score at d2 and d7
Time frame: 2 and 7 days after randomisation/treament initiation
Dyspnea's visual analogic scale at d2, d4 and d7
Time frame: 2, 4 and 7 days after randomisation/treament initiation
Blood saturation without oxygen therapy at d2, d4 and d7
Time frame: 2, 4 and 7 days after randomisation/treament initiation
Katz's ADL (Activities Daily Living) score at d2,d4 and d7
Time frame: 2, 4 and 7 days after randomisation/treament initiation
Asthenia's evaluation at d2,d4 and d7
Time frame: 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
Time frame: 2, 4 and 7 days after randomisation/treament initiation
Morbidity-mortality at d2,d4 and d7
Time frame: 2, 4 and 7 days after randomisation/treament initiation
Blood inflammation parameters at d2,d4 and d7
Time frame: 2, 4 and 7 days after randomisation/treament initiation
Vitamin C blood level at d7
Time frame: 7 days after randomisation/treament initiation
Results and safety
The study was stopped early (reason given: target number of inclusion not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélie LAFARGUE, MD principal investigator
University Hospital Bordeaux (France)
Antoine BENARD, MD study chair
University Hospital Bordeaux (France)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin C in people with Pneumonia With Hospitalized Elderly Patient, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: target number of inclusion not reached). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the NYHA score between d-15 and d4 after treatment initiation (time frame: 4 days after randomisation/treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.