Journal article
Clindamycin adjunctive therapy for severe Staphylococcus aureus treatment evaluation (CASSETTE)—an open-labelled pilot randomized controlled trial
JAC-Antimicrobial Resistance, Vol.4(1), Art. dlac014
2022
Abstract
Background
Combination antibiotic therapy with an antitoxin agent, such as clindamycin, is included in some guidelines for severe, toxin-mediated Staphylococcus aureus infections. The evidence to support this practice is currently limited to in vitro, animal and observational human case-series data, with no previous randomized controlled trials (RCTs).
Objectives
This pilot RCT aimed to determine the feasibility of conducting a clinical trial to examine if adjunctive clindamycin with standard therapy has greater efficacy than standard therapy alone for S. aureus infections.
Methods
We performed an investigator-initiated, open-label, multicentre, pilot RCT (ACTRN12617001416381p) in adults and children with severe S. aureus infections, randomized to standard antibiotic therapy with or without clindamycin for 7 days.
Results
Over 28 months, across nine sites, 127 individuals were screened and 34 randomized, including 11 children (32%). The primary outcome—number of days alive and free of systemic inflammatory response syndrome ≤14 days—was similar between groups: clindamycin (3 days [IQR 1–6]) versus standard therapy (4 days [IQR 0–8]). The 90 day mortality was 0% (0/17) in the clindamycin group versus 24% (4/17) in the standard therapy group. Secondary outcomes—microbiological relapse, treatment failure or diarrhoea—were similar between groups.
Conclusions
As the first clinical trial assessing adjunctive clindamycin for S. aureus infections, this study indicates feasibility and that adults and children can be incorporated into one trial using harmonized endpoints, and there were no safety concerns. The CASSETTE trial will inform the definitive S. aureus Network Adaptive Platform (SNAP) trial, which includes an adjunctive clindamycin domain and participants with non-severe disease.
Details
- Title
- Clindamycin adjunctive therapy for severe Staphylococcus aureus treatment evaluation (CASSETTE)—an open-labelled pilot randomized controlled trial
- Authors/Creators
- A.J. Campbell (Author/Creator) - Princess Margaret Hospital for ChildrenR. Dotel (Author/Creator) - The University of SydneyM. Braddick (Author/Creator) - Townsville HospitalP.N. Britton (Author/Creator) - Children's Hospital at WestmeadD.P. Eisen (Author/Creator) - James Cook UniversityJ.R. Francis (Author/Creator) - Menzies School of Health ResearchS. Lynar (Author/Creator) - Menzies School of Health ResearchB. McMullan (Author/Creator) - Sydney Children's HospitalN. Meagher (Author/Creator) - The University of MelbourneJ. Nelson (Author/Creator) - Menzies School of Health ResearchM.V.N. O’Sullivan (Author/Creator)D.J. Price (Author/Creator) - The University of MelbourneJ.O. Robinson (Author/Creator) - Royal Perth HospitalA. Whelan (Author/Creator) - The Kids Research Institute AustraliaS.Y.C. Tong (Author/Creator) - Peter Doherty InstituteA.C. Bowen (Author/Creator) - Princess Margaret Hospital for ChildrenJ.S. Davis (Author/Creator) - Menzies School of Health Research
- Publication Details
- JAC-Antimicrobial Resistance, Vol.4(1), Art. dlac014
- Publisher
- Oxford University Press
- Identifiers
- 991005541501507891
- Copyright
- © 2022 The Authors.
- Murdoch Affiliation
- College of Science, Health, Engineering and Education
- Language
- English
- Resource Type
- Journal article
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