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Adjunctive intravenous then oral vitamin C for moderate and severe community-acquired pneumonia in hospitalized adults: feasibility of randomized controlled trial.

ABSTRACT: Patients hospitalised with community acquired pneumonia (CAP) have low peripheral blood vitamin C concentrations and limited antioxidant capacity. The feasibility of a trial of vitamin C supplementation to improve patient outcomes was assessed. Participants with moderate and severe CAP (CURB-65 ≥ 2) on intravenous antimicrobial treatment were randomised to either intravenous vitamin C (2.5 g 8 hourly) or placebo before switching to oral intervention (1 g tds) for 7 days when they were prescribed oral antimicrobial therapy. Of 344 patients screened 75 (22%) were randomised and analysed. The median age was 76 years, and 43 (57%) were male. In each group, one serious adverse event that was potentially intervention related occurred, and one subject discontinued treatment. Vitamin C concentrations were 226 µmol/L in the vitamin C group and 19 µmol/L in the placebo group (p < 0.001) after 3 intravneous doses. There were no signficant differences between the vitamin C and placebo groups for death within 28 days (0 vs. 2; p = 0.49), median length of stay (69 vs. 121 h; p = 0.07), time to clinical stability (22 vs. 49 h; p = 0.08), or readmission within 30 days (1 vs. 4; p = 0.22). The vitamin C doses given were safe, well tolerated and saturating. A randomised controlled trial to assess the efficacy of vitamin C in patients with CAP would require 932 participants (CURB-65 ≥ 2) to observe a difference in mortality and 200 participants to observe a difference with a composite endpoint such as mortality plus discharge after 7 days in hospital. These studies are feasible in a multicentre setting.

SUBMITTER: Chambers ST

PROVIDER: S-EPMC10363531 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

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Adjunctive intravenous then oral vitamin C for moderate and severe community-acquired pneumonia in hospitalized adults: feasibility of randomized controlled trial.

Chambers Stephen T ST Storer Malina M Scott-Thomas Amy A Slow Sandy S Williman Jonathan J Epton Michael M Murdoch David R DR Metcalf Sarah S Carr Anitra A Isenman Heather H Maze Michael M

Scientific reports 20230723 1

Patients hospitalised with community acquired pneumonia (CAP) have low peripheral blood vitamin C concentrations and limited antioxidant capacity. The feasibility of a trial of vitamin C supplementation to improve patient outcomes was assessed. Participants with moderate and severe CAP (CURB-65 ≥ 2) on intravenous antimicrobial treatment were randomised to either intravenous vitamin C (2.5 g 8 hourly) or placebo before switching to oral intervention (1 g tds) for 7 days when they were prescribed ...[more]

PMID: 37482552

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Project description:BackgroundThe most frequently prescribed regimens for the treatment of hospitalized adults with suspected or documented community-acquired bacterial pneumonia (CABP), an acute bacterial infection of the pulmonary parenchyma, are ceftriaxone plus a macrolide, or a respiratory fluoroquinolone. Although these regimens are consistent with expert guidelines, there are growing concerns regarding their safety and efficacy. Omadacycline is a once-daily antibiotic with oral and intravenous (IV) formulations; it was recently approved in the United States for the treatment of adults with CABP.ObjectiveTo estimate the cost impact of shortening hospital stay or avoiding hospitalization when using a treatment with an IV and an oral formulation, such as omadacycline, versus an IV-only drug regimen, such as ceftriaxone plus a macrolide, in adults with CABP who are not candidates for respiratory fluoroquinolone therapy.MethodsWe developed 2 conceptual healthcare decision models to identify potential cost-saving opportunities in hospitalized adults with CABP who receive omadacycline versus ceftriaxone plus a macrolide. The early hospital discharge model examined the cost impact of shifting patients with CABP from inpatient treatment with ceftriaxone plus a macrolide to inpatient IV omadacycline treatment and early hospital discharge with oral omadacycline. The hospital-avoidance model examined the cost impact of omadacycline treatment in the outpatient setting in patients with CABP who have low disease severity. The models defined the upper range of the daily acquisition cost for omadacycline that conferred cost-savings relative to inpatient treatment with ceftriaxone plus a macrolide.ResultsIn the early hospital discharge model, omadacycline showed cost-savings with a 2-day hospital stay reduction if the daily cost of omadacycline was ≤$836, almost twice its wholesale acquisition cost. In the hospital-avoidance model, the daily omadacycline thresholds that still conferred cost-savings relative to inpatient ceftriaxone plus a macrolide ranged from $1302 to $1334, based on a daily wholesale acquisition cost of $450 for omadacycline, depending on the potential use of the emergency department and an observation unit.ConclusionThe study findings show that the targeted use of omadacycline for the treatment of select patient populations with CABP could result in cost-savings relative to inpatient treatment with ceftriaxone plus a macrolide.

Project description:BackgroundCommunity-acquired pneumonia (CAP) is a leading cause of morbidity and mortality worldwide, but few studies have evaluated the feasibility of routine patient-reported outcome measures (PROMs) in this illness. This study investigates the feasibility and limitations of three credible PROM instruments in a representative hospitalized cohort to identify potential barriers to routine application.MethodsA sample of multimorbid hospitalized subjects meeting a standardized CAP definition was recruited. Demographic and clinical data of those able and unable to participate in PROM assessment were compared. The EQ-5D-5L, CAP-Sym 18 Questionnaire, and Late-Life Function and Disability Instrument (LLFDI) were administered (via face-to-face interview) at admission and discharge and (via phone interview or mail) at 30 and 90 days post-discharge. Feasibility measures included the proportion of individuals able to participate in assessment, attrition rates, data completeness, and instrument completion times. Scores at admission and 30 days post-discharge were examined for association with age.ResultsOf 82 subjects screened, 44 (54%) participated. Cognitive impairment (n = 12, 15%) commonly precluded participation. Seventeen (39%) participants were lost to follow-up by 90 days. Missing data at item level was negligible for all instruments, regardless of the mode of completion. Completion of the three instruments collectively in a face-to-face interview took a median of 17 min (IQ range 13-21) per participant. The burden of reported symptoms at admission was higher for younger participants aged 18-74 years (mean (standard deviation)) CAP-Sym 18 score at admission 34.2 (18.6) vs. 19.0 (11.3) for those aged ≥ 75 years.ConclusionsRoutine application of PROMs can provide valuable information relating to multiple aspects of clinical recovery for individuals hospitalized with CAP. However, heterogeneous demographic characteristics and complex underlying health status introduce challenges to feasibility and interpretability of these instruments in this population.Trial registrationClinicalTrials.gov, NCT02835040.

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Adjunctive intravenous then oral vitamin C for moderate and severe community-acquired pneumonia in hospitalized adults: feasibility of randomized controlled trial.

Publications

Adjunctive intravenous then oral vitamin C for moderate and severe community-acquired pneumonia in hospitalized adults: feasibility of randomized controlled trial.

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