Vitamin C in Community Acquired Pneumonia: A pilot study

Phase 2

• Conditions: Community Acquired Pneumonia; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12619000256178
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-20
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1) Community acquired pneumonia (CAP) defined as: a new inflammatory infiltrate on chest radiograph and the presence of at least one 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 < 4x104 cells/µL.
2) Aged > 17 years;
3) Able to provide informed consent
4) Requiring IV antibiotic therapy;
5) Moderate or severe pneumonia with a CURB-65 score > 1 at any time during their admission.

Exclusion Criteria

1)Pneumonia is not the principal reason for admission;
2)CURB-65 score 0-1;
3)Pneumonia associated with bronchial obstruction, bronchiectasis, cystic fibrosis, or active tuberculosis;
4) Cannot provide informed consent
5)Previous hospitalisation within 2 weeks so that hospital-acquired pneumonia cannot be ruled out;
6)Severe immunosuppression ( eg 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 anti-rejection medication);
7)Chronic kidney disease with a creatinine clearance <10 mls/sec), or receiving dialysis;
8)Known or suspected G6PD deficiency.
9)Pregnancy and breast feeding
10)Haemachromatosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality in hospitalised patients with moderate/severe community acquired pneumonia (CURB-65 >1) as assessed by data-linkage to medical records.[30 days post-treatment initiation]

Secondary Outcome Measures

Name	Time	Method
Rate of recruitment of patients hospitalised with moderate/severe community acquired pneumonia (CURB-65 >1).[Overall trial period-18 months];Length of hospital stay as assessed by data-linkage to medical records[censored at day 30 post-treatment initiation];Admission to ICU as assessed by data-linkage to medical records[censored at day 30 post-treatment initiation];Readmission to hospital as assessed by data-linkage to medical records[censored at 90 days post-treatment initiation];Hospital mortality as assessed by data-linkage to medical records[30 and 90 days post-treatment initiation];Days until death as assessed by data-linkage to medical records[censored at 90 days post-treatment initiation];Quality of life as assessed by study-specific questionnaire[30 days post-treatment initiation];Resolution of symptoms as assessed by study-specific questionnaire[30 days post-treatment initiation]