Short course antibiotic treatment of Gram-negative bacteraemia (GNB5): A study protocol for a randomised controlled trial
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Short course antibiotic treatment of Gram-negative bacteraemia (GNB5) : A study protocol for a randomised controlled trial. / Tingsgård, Sandra; Israelsen, Simone Bastrup; Thorlacius-Ussing, Louise; Frahm Kirk, Karina; Lindegaard, Birgitte; Johansen, Isik S.; Knudsen, Andreas; Lunding, Suzanne; Ravn, Pernille; Østergaard Andersen, Christian; Benfield, Thomas.
In: BMJ Open, Vol. 13, No. 5, e068606, 2023.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Short course antibiotic treatment of Gram-negative bacteraemia (GNB5)
T2 - A study protocol for a randomised controlled trial
AU - Tingsgård, Sandra
AU - Israelsen, Simone Bastrup
AU - Thorlacius-Ussing, Louise
AU - Frahm Kirk, Karina
AU - Lindegaard, Birgitte
AU - Johansen, Isik S.
AU - Knudsen, Andreas
AU - Lunding, Suzanne
AU - Ravn, Pernille
AU - Østergaard Andersen, Christian
AU - Benfield, Thomas
N1 - Funding Information: The study is partly financially supported by a grant from Hvidovre Hospital Strategic Research Fund, Danish Regions Medicine Grant, grant number EMN-2019-01055, and Capital Region of Denmark Research Fund, grant number A6688. Additional federal funding will be sought. Study participants and the Research Ethics Committee of the Capital Region of Denmark will be informed if additional funding has been granted. Publisher Copyright: © 2023 BMJ Publishing Group. All rights reserved.
PY - 2023
Y1 - 2023
N2 - Introduction Prolonged use of antibiotics is closely related to antibiotic-Associated infections, antimicrobial resistance and adverse drug events. The optimal duration of antibiotic treatment for Gram-negative bacteremia (GNB) with a urinary tract source of infection is poorly defined. Methods and analysis Investigator-initiated multicentre, non-blinded, non-inferiority randomised controlled trial with two parallel treatment arms. One arm will receive shortened antibiotic treatment of 5 days and the other arm will receive antibiotic treatment of 7 days or longer. Randomisation will occur in equal proportion (1:1) no later than day 5 of effective antibiotic treatment as determined by antibiogram. Immunosuppressed patients and those with GNB due to non-fermenting bacilli (Acinetobacter spp, Pseudomonas spp), Brucella spp, Fusobacterium spp or polymicrobial growth are ineligible. The primary endpoint is 90-day survival without clinical or microbiological failure to treatment. Secondary endpoints include all-cause mortality, total duration of antibiotic treatment, hospital readmission and Clostridioides difficile infection. Interim safety analysis will be performed after the recruitment of every 100 patients. Given an event rate of 12%, a non-inferiority margin of 10%, and 90% power, the required sample size to determine non-inferiority is 380 patients. Analyses will be performed on both intention-To-Treat and per-protocol populations. Ethics and dissemination The study is approved by the Danish Regional Committee on Health Research (H-19085920) and the Danish Medicines Agency (2019-003282-17). The results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal. Trial registration number ClinicalTrials.Gov:NCT04291768.
AB - Introduction Prolonged use of antibiotics is closely related to antibiotic-Associated infections, antimicrobial resistance and adverse drug events. The optimal duration of antibiotic treatment for Gram-negative bacteremia (GNB) with a urinary tract source of infection is poorly defined. Methods and analysis Investigator-initiated multicentre, non-blinded, non-inferiority randomised controlled trial with two parallel treatment arms. One arm will receive shortened antibiotic treatment of 5 days and the other arm will receive antibiotic treatment of 7 days or longer. Randomisation will occur in equal proportion (1:1) no later than day 5 of effective antibiotic treatment as determined by antibiogram. Immunosuppressed patients and those with GNB due to non-fermenting bacilli (Acinetobacter spp, Pseudomonas spp), Brucella spp, Fusobacterium spp or polymicrobial growth are ineligible. The primary endpoint is 90-day survival without clinical or microbiological failure to treatment. Secondary endpoints include all-cause mortality, total duration of antibiotic treatment, hospital readmission and Clostridioides difficile infection. Interim safety analysis will be performed after the recruitment of every 100 patients. Given an event rate of 12%, a non-inferiority margin of 10%, and 90% power, the required sample size to determine non-inferiority is 380 patients. Analyses will be performed on both intention-To-Treat and per-protocol populations. Ethics and dissemination The study is approved by the Danish Regional Committee on Health Research (H-19085920) and the Danish Medicines Agency (2019-003282-17). The results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal. Trial registration number ClinicalTrials.Gov:NCT04291768.
KW - Clinical Trial
KW - Clinical trials
KW - Infection control
KW - INFECTIOUS DISEASES
KW - Urinary tract infections
U2 - 10.1136/bmjopen-2022-068606
DO - 10.1136/bmjopen-2022-068606
M3 - Journal article
C2 - 37156588
AN - SCOPUS:85158123728
VL - 13
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 5
M1 - e068606
ER -
ID: 372835200