Is it better to treat pneumonia by customising antibiotic treatment based on the PIBCAP test compared to the current standard NHS treatment?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2019
INTERVENTION: This study is a pragmatic, multicentre, open randomised controlled trial. We will recruit from 5 UK hospitals. Participants will be identified by the clinical care team or research nurse by assessing those admitted to hospital with community‐acquired pneumonia. Eligible participants will randomised at baseline to either control treatment or the PIBCAP intervention: 1. The control arm will have investigations and treatment per NICE Pneumonia guideline. 2. The participants randomised to the PIBCAP arm will have PIBCAP investigations performed on their admission throat swab, spontaneous sputum (if available) and urine (if available). Initially this group will have standard antibiotic treatment as per NICE Pneumonia guideline, but then following PIB CAP results treatment will be personalised within 36 hours of hospital admission. All participants will be asked to complete patient questionnaires and have clinical assessments recorded at baseline, 7 days and 30 days after enrollment. The day 7 visit is a safety assessment and the day 30 visit is to assess recovery. Interventions will be delivered by the clinical care team supported by the research nurse. The primary outcome measure is the Desirability of Outcome Ranking (DOOR) to assess the efficacy and safety of PIB CAP therapy based on assessing (A) day 30 clinical response and (B) day 30 total antibiotics Defined Daily Dose (DDD) to ensure by narrowing antibiotics this does not lead to subsequent additional antibiotic use. This study will assess the utility of a pneumonia investigation bundle using fast multiplex real‐time Polymerase Chain Reaction assays for 26 respiratory bacteria and viruses along with urine for Legionella Antigen test (using BinaxNOW®) to personalise antibiotic treatment within 36 hours of hospital admission. Twelve months after enrollment the researchers will use central NHS and GP r CONDITION: Community‐acquired pneumonia ; Respiratory ; Pneumonia, organism unspecified PRIMARY OUTCOME: Clinical outcome measured with Desirability of Outcome Ranking (DOOR) and then further ranked using the Response Adjusted for Duration of Antibiotic Risk, assessed at day 30 INCLUSION CRITERIA: 1. Hospitalised for CAP 2. Uncomplicated CAP confirmed by physician 3. CURB65 score two or more 4. Aged 16 and over SECONDARY OUTCOME: ; 1. CAP resolution (Y/N), measured by improvement of symptoms and clinical signs related to CAP, CRP level< 20 mg/L, and not on antibiotics related to CAP, assessed at day 7 and day 30; 2. Major adverse events (Y/N) and number, measured by clinician reporting an event in medical records, assessed at day 7 and day 30; 3. Readmissions to hospital within 30 days due to CAP, measured by admission recorded in patient records, assessed at day 30; 4. Death (at 30 days and time to death), measured by death recorded in patient records, assessed at day 30; 5. Narrowing spectrum of antibiotics, measured by clinician confirming that antibiotic prescriptions were altered according to PIBCAP results, assessed at day 7 and day 30; 6. Macrolide DDD, measured by calculating the daily dose of macrolide antibiotics prescribed, assessed at day 30; 7. Alteration or addition of antibiotic therapy, measured by antibiotic prescriptions in medical records, assessed at day 7 and day 30; 8. Length of hospital stay, measured by admission and discharge dates recorded in patient records, assessed at day 7 and day 30; 9. Antibiotic side effects, measured by clinician reporting an event in medical records, assessed at day 7 and day 30; 10. Antibiotic costs measured within trial analysis and longer term economic modelling, assessed at day 30; 11. Participant symptoms, measured by clinician reporting an event in medical records, assessed at day 7 and day 30; 12. Antibiotic resistance in bacteria isolated, measured within trial analysis, assessed at day 30; 13. The optimum specimen(s) for assessment of CAP for bacteria, atypical bacteria and viruses, measured within trial analysis, assessed at day 30; 14. Cost per QALY at 30 days, measured within trial analysis and longer term economic modelling, assessed at day 30; 15. Cost per DDD of antibiotics at 30 days, measured within trial analysis and longer term economic modelling, assessed at day 30; ; Additional secondary outcome measures in the PIBCAP group:; 1. Time to PIB, measured within trial analysis from times recorded in CRF, assessed at baseline; 2. Whether clinicians personalise antibiotics based within 36 hours of hospital admission using the PIB CAP bundle CAP results, measured by within trial analysis and by clinician confirming a change in prescribing, assessed at day 7 and day 30; 3. Proportion of PIB CAP that produces a result, measured within trial analysis from lab results recorded in patient medical record, assessed at baseline;
Epistemonikos ID: aeda97766d1e3822798742053dcf6aeda678f946
First added on: Mar 20, 2020