ACTRN12619000256178.

Study name	Vitamin C in community acquired pneumonia: a pilot study
Methods	Design: randomised controlled trial Unit of randomisation: individually randomised
Participants	Location setting: New Zealand Sample size: 140 participants Sex: both Age: 18 years Inclusion criteria: Community‐acquired pneumonia defined as: a new inflammatory infiltrate on chest radiograph and the presence of at least 1 of the following acute respiratory signs and symptoms: cough, sputum production, dyspnoea, core body temperature of 38.0 °C or higher, auscultatory findings of abnormal breathing sounds or rales, leucocyte count > 104 cells/µL or < 4 x 104 cells/µL Aged > 17 years Able to provide informed consent Requiring IV antibiotic therapy Moderate or severe pneumonia with a CURB‐65 score > 1 at any time during their admission Exclusion criteria: Pneumonia is not the principal reason for admission CURB‐65 score 0 to 1 Pneumonia associated with bronchial obstruction, bronchiectasis, cystic fibrosis, or active tuberculosis Cannot provide informed consent Previous hospitalisation within 2 weeks so that hospital‐acquired pneumonia cannot be ruled out Severe immunosuppression (e.g. neutropenia 350 cells/µL, or HIV‐positive and a CD4 cell count below 350 cells/µL, receiving cancer chemotherapy, receiving prednisone > 20 mg daily or antirejection medication) Chronic kidney disease with a creatinine clearance < 10 mL/s, or receiving dialysis Known or suspected G6PD deficiency Pregnancy and breastfeeding Haemachromatosis
Interventions	Intervention: vitamin C: intravenous infusion of 2.5 g/8 hours will be started as soon as possible, but not later than 72 hours after hospital admission and within 24 hours of the documentation of a community‐acquired pneumonia CURB‐65 severity score > 1. Intravenous vitamin C will be provided whilst the participant is receiving IV antimicrobial therapy and will continue until the treatment is changed to oral antimicrobial therapy or for a maximum of 7 days. Following the cessation of IV vitamin C therapy, the participant will receive a further 7 days of oral vitamin C at a dose of 1 g (2 x 500 mg chewable tablets) 3 times per day. Participants will receive vitamin C for a minimum of 8 days and a maximum of 14 days.
Outcomes	Primary outcome: All‐cause mortality in hospitalised participants with moderate/severe CAP (CURB‐65 > 1) Secondary outcomes: Admission to ICU Days until death Hospital mortality Length of hospital stay Quality of life Rate of recruitment of patients hospitalised with moderate/severe CAP Readmission to hospital Resolution of symptoms
Starting date	20 February 2019
Contact information	Stephen Chambers, Professor University of Otago, Christchurch 2 Riccarton Avenue Christchurch Central Christchurch, 8011, New Zealand +64 3 3640649 steve.chambers@otago.ac.nz
Notes	Not yet recruiting