Authors (including presenting author) :
Rainer TH(1)(2), Lam PK(1)(2), Wai KCA(1)(2), Leung SC(1), Leung RYY(1)(2), Wong CKH(1), Gill H(1)(2), Hung IFN(1)(2), Lam WWT(1), Chan WWL(1)(3), Lee SY(1), Yeung MHT(1), Cheung ACC(1)(3), Lau JMT(4), Lee SF(5), Choi YF(6), Lee HFL(7), Mok KL(8), Lam HC(9)
Affiliation :
(1)The University of Hong Kong, (2)Queen Mary Hospital, (3)Gleneagles Hong Kong Hospital, (4)North Lantau Hospital, (5)Princess Margaret Hospital, (6)Pamela Youde Nethersole Eastern Hospital, (7)Queen Elizabeth Hospital, (8)Ruttonjee Hospital, (9)United Christian Hospital
Introduction :
Cancer patients attending Emergency Departments (ED) with fever and recent chemotherapy are often classified as suspected neutropenic fever (sNF). To meet the 1-hour door-to-antibiotic time target they are treated empirically with ultrabroad-spectrum antibiotics (UBSAs), before the absolute neutrophil count (ANC) is available. Studies on this treatment approach are lacking.
Objectives :
This trial evaluates whether antibiotic prescribing and pathways for sNF in adults can be safely reduced through implementing a multifaceted antibiotic stewardship intervention (ASTERIC). We hypothesise that ASTERIC effectively and safely reduces UBSA use compared to standard of care (SoC).
Methodology :
This pragmatic, multi-centre, type 1 hybrid effectiveness-implementation, stepped-wedge cluster randomised controlled trial will recruit 648 adult patients (324 per group) across eight Hong Kong hospitals. Eligible participants will present with tympanic temperature ≥38.3ºC within 24 hours before ED registration; and last chemotherapy or targeted therapy ≤6 weeks for solid tumour, or in any period following therapies against leukaemia, lymphoma, myelodysplastic syndrome, aplastic anaemia, multiple myeloma, or recipient of Haematopoietic Stem Cell Transplantation. Healthcare professionals receive a multifaceted stewardship intervention consisting of risk assessment tools, fast track ANCs, a decision tool for patient management and antibiotic use supported by an educational package and staff interaction programmes (ASTERIC protocol). The instruments are ANC, cancer therapy and chronic illness therapy scores; Proctor conceptual framework for implementation research outcomes incorporating RE-AIM.
The primary outcome is the mean total UBSA dose prescribed within 7 days, with serious adverse events (SAEs) evaluated at 30 days. Secondary outcomes include effectiveness, safety, quality of life, and cost-effectiveness, analysed through ITT, PP, and AT approaches. Mixed methods, guided by the Theoretical Domains Framework (TDF), will assess implementation outcomes.
Result & Outcome :
ASTERIC will inform health policy with improvement in services managing stable sNF, evidenced by safe antibiotic stewardship, early antibiotic de-escalation, and reduced costs and length of stay. ASTERIC will commence in February 2025.
