Study design and participants
pneumonia, acute illness, cough, feverishness, shortness of breath
INFILTRATE, SECONDARY, PNEUMONIA, RECRUITMENT
The study was conducted in Christchurch Hospital, New Zealand, a secondary and tertiary care referral hospital serving more than 550,000 people. Participants were adults (aged ≥ 18 years) admitted to the general medical or respiratory services from November 2019 to April 2021 with CAP. This was defined as an acute illness acquired outside a health care setting with clinical features that included increased cough, sputum production, shortness of breath and feverishness, and a new inflammatory infiltrate on chest radiograph.Potential participants were identified upon admission and notified to the investigators for possible enrolment. The exclusion criteria were: (1) admission to hospital > 48 h prior to screening, (2) unable to give informed consent, (3) CURB65 pneumonia severity score of < 2Patients who were randomised, but subsequently found to have an alternative diagnosis, or were switched to oral therapy before receiving an intravenous dose of study agent were excluded from the study.All clinical decisions were made by the clinical care team. Local guidelines that recommend dual therapy with a beta lactam antimicrobial agent (amoxicillin, amoxicillin/clavulanate or cefuroxime) and a macrolide (azithromycin) for all patients with CURB-65 score of ≥ 2 with some clinical discretionThe initial patient review, recruitment and consenting was done by one of the clinical team (S.T.C, M.M) after notification together with a research assistant. The clinical data was entered first into a paper form with pre-specified fields, and then into a RedCap database by the research assistant. Overall this required a morning for the clinician each day and a whole day for the research assistant for maintaining the database.The study was approved by the New Zealand Northern B Health and Disability Ethics Committee (18/NTB/218) and all participants gave written informed consent. The trial was conducted according to the principles of the Declaration of Helsinki and was registered with the Universal trial number U1111-1222-3105 (20/02/2019) and Australia New Zealand Clinical Trials Registry, 