Evidence map›Paper›PMID 31196132›Full record

ArticleTrials2019

CASSETTE-clindamycin adjunctive therapy for severe Staphylococcus aureus treatment evaluation: study protocol for a randomised controlled trial.

Ravindra Dotel, Steven Y C Tong, Asha Bowen, Jane N Nelson, Matthew V N O'Sullivan, Anita J Campbell, Brendan J McMullan, Philip N Britton, Joshua R Francis, Damon P Eisen and 3 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.0field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Clindamycin adjunctive therapy for severeJAC-antimicrobial resistance · 2022
    Article
  5. SevereFrontiers in pediatrics · 2022
    Article
  6. Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 2 countries.

Ravindra DotelCentre for Infectious Diseases and Microbiology, Westmead Hospital, University of Sydney, Sydney, Australia. ravindra.dotel@health.nsw.gov.au.ORCID http://orcid.org/0000-0002-3379-6135
Steven Y C TongVictorian Infectious Disease Service, The Royal Melbourne Hospital-Doherty Department, University of Melbourne, Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
Asha BowenDepartment of Infectious Diseases, Perth Children's Hospital, Perth, Australia.
Jane N NelsonMenzies School of Health Research, Darwin, Australia.
Matthew V N O'SullivanCentre for Infectious Diseases and Microbiology, Westmead Hospital, University of Sydney, Sydney, Australia.
Anita J CampbellDepartment of Infectious Diseases, Perth Children's Hospital, Perth, Australia.
Brendan J McMullanDepartment of Immunology and Infectious Diseases, Sydney Children's Hospital, Sydney, Australia.
Philip N BrittonDepartment of Infectious Diseases and Microbiology, Children's Hospital Westmead, Sydney, Australia.
Joshua R FrancisMenzies School of Health Research, Darwin, Australia.
Damon P EisenTownsville Hospital and Health Service, Townsville, Australia.
Owen RobinsonDepartment of Infectious Diseases, Royal Perth Hospital, Perth, Australia.
Laurens ManningDepartment of Infectious Diseases, Fiona Stanley Hospital, Perth, Australia.
Joshua S DavisMenzies School of Health Research, Darwin, Australia.
Menzies School of Health Research · AUThe University of Sydney · AUThe Kids Research Institute Australia · AUJohn Hunter Hospital · AUMurdoch University · AUThe University of Melbourne · AUThe University of Western Australia · AUTownsville Hospital · AU

Funding

National Health and Medical Research Council GNT1131932
6 · The paper itself

Abstract

backgroundExotoxins are important virulence factors in Staphylococcus aureus. Clindamycin, a protein synthesis inhibitor antibiotic, is thought to limit exotoxin production and improve outcomes in severe S. aureus infections. However, randomised prospective data to support this are lacking.

methodsAn open-label, multicentre, randomised controlled trial (RCT) will compare outcome differences in severe S. aureus infection between standard treatment (flucloxacillin/cefazolin in methicillin-susceptible S. aureus; and vancomycin/daptomycin in methicillin-resistant S. aureus) and standard treatment plus an additional clindamycin given for 7 days. We will include a minimum of 60 participants (both adult and children) in the pilot study. Participants will be enrolled within 72 h of an index culture. Severe infections will include septic shock, necrotising pneumonia, or multifocal and non-contiguous skin and soft tissue/osteoarticular infections. Individuals who are immunosuppressed, moribund, with current severe diarrhoea or Clostridiodes difficile infection, pregnant, and those with anaphylaxis to β-lactams or lincosamides will be excluded. The primary outcomes measure is the number of days alive and free (1 or 0) of systemic inflammatory response syndrome (SIRS) within the first 14 days post randomisation. The secondary outcomes measure will include all-cause mortality at 14, 42, and 90 days, time to resolution of SIRS, proportion with microbiological treatment failure, and rate of change of C-reactive protein over time. Impacts of inducible clindamycin resistance, strain types, methicillin susceptibility, and presence of various exotoxins will also be analysed. DISCUSSION: This study will assess the effect of adjunctive clindamycin on patient-centred outcomes in severe, toxin-mediated S. aureus infections. The pilot study will provide feasibility for a much larger RCT.

trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12617001416381p . Registered on 6 October 2017.

Indexed as

Anti-Bacterial AgentsClindamycinStaphylococcal InfectionsAdolescentAdultChildChild, PreschoolC-Reactive ProteinHumansInfantMulticenter Studies as TopicOutcome Assessment, Health CarePilot ProjectsRandomized Controlled Trials as TopicResearch DesignAnti-Bacterial AgentsClindamycinC-Reactive ProteinClindamycinExotoxinsLeukocidinsProspective studiesStaphylococcus aureus

Identifiers

PMID31196132
PMCPMC6567404
OpenAlexW2952452550

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.