TY - JOUR
T1 - Short-course antibiotic therapy of 5 days in community-acquired pneumonia (CAP5)
T2 - study protocol for a randomised controlled trial
AU - Israelsen, Simone Bastrup
AU - Tingsgård, Sandra
AU - Thorlacius-Ussing, Louise
AU - Knudsen, Andreas
AU - Lindegaard, Birgitte
AU - Johansen, Isik S
AU - Mygind, Lone Hagens
AU - Ravn, Pernille
AU - Benfield, Thomas
N1 - © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2023/7/21
Y1 - 2023/7/21
N2 - INTRODUCTION: The optimal duration of antibiotic therapy for community-acquired pneumonia (CAP) is unsettled. Short-course therapy has proved successful in clinical trials but is not yet implemented in everyday clinical practice. Validation of results from randomised controlled trials is crucial to evaluate existing evidence and provide clinicians with assurance of using new treatment strategies. In a pragmatic framework, we aim to assess the use of short-course antibiotic therapy guided by the onset of clinical stability in patients hospitalised with CAP.METHODS AND ANALYSIS: This study is a randomised controlled trial with a non-inferiority design that will examine the efficacy of short-course antibiotic therapy in patients hospitalised with CAP. From six hospitals across Denmark, we plan to enrol 564 patients between 2019 and 2024. Within 3-5 days after initiating antibiotic therapy, participants will be randomised 1:1 to parallel treatment arms: (1) short-course antibiotic therapy of 5 days or (2) antibiotic therapy of at least 7 days. The primary outcome will be 90-day readmission-free survival and will be estimated as an absolute risk difference with a predefined non-inferiority margin of -6%. Secondary outcomes will comprise other safety measures including new antibiotics, adverse events, length of hospital stay and postdischarge outpatient visits. Both intention-to-treat and per-protocol analyses will be performed.ETHICS AND DISSEMINATION: This study has been approved by the Health Research Ethics Committee of the Capital Region of Denmark (identifier number: H-19014479). Trial data will be made available in anonymous form when the trial has ended.TRIAL REGISTRATION NUMBER: NCT04089787, ClinicalTrials.Gov.
AB - INTRODUCTION: The optimal duration of antibiotic therapy for community-acquired pneumonia (CAP) is unsettled. Short-course therapy has proved successful in clinical trials but is not yet implemented in everyday clinical practice. Validation of results from randomised controlled trials is crucial to evaluate existing evidence and provide clinicians with assurance of using new treatment strategies. In a pragmatic framework, we aim to assess the use of short-course antibiotic therapy guided by the onset of clinical stability in patients hospitalised with CAP.METHODS AND ANALYSIS: This study is a randomised controlled trial with a non-inferiority design that will examine the efficacy of short-course antibiotic therapy in patients hospitalised with CAP. From six hospitals across Denmark, we plan to enrol 564 patients between 2019 and 2024. Within 3-5 days after initiating antibiotic therapy, participants will be randomised 1:1 to parallel treatment arms: (1) short-course antibiotic therapy of 5 days or (2) antibiotic therapy of at least 7 days. The primary outcome will be 90-day readmission-free survival and will be estimated as an absolute risk difference with a predefined non-inferiority margin of -6%. Secondary outcomes will comprise other safety measures including new antibiotics, adverse events, length of hospital stay and postdischarge outpatient visits. Both intention-to-treat and per-protocol analyses will be performed.ETHICS AND DISSEMINATION: This study has been approved by the Health Research Ethics Committee of the Capital Region of Denmark (identifier number: H-19014479). Trial data will be made available in anonymous form when the trial has ended.TRIAL REGISTRATION NUMBER: NCT04089787, ClinicalTrials.Gov.
KW - Humans
KW - Aftercare
KW - Patient Discharge
KW - Community-Acquired Infections/drug therapy
KW - Pneumonia/drug therapy
KW - Anti-Bacterial Agents/therapeutic use
KW - Randomized Controlled Trials as Topic
KW - INFECTIOUS DISEASES
KW - Respiratory infections
KW - Clinical trials
UR - http://www.scopus.com/inward/record.url?scp=85165494095&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2022-069013
DO - 10.1136/bmjopen-2022-069013
M3 - Journal article
C2 - 37479519
SN - 2399-9772
VL - 13
SP - e069013
JO - BMJ Paediatrics Open
JF - BMJ Paediatrics Open
IS - 7
M1 - e069013
ER -