CASSETTE - Clindamycin Adjunctive therapy for Severe Staphylococcus aurEus Treatment Evaluation – An investigator-initiated, multi-centre, parallel group, open labelled pilot randomised controlled trial

Phase 4

Recruiting

• Conditions: Severe methicillin-susceptible staphylococcus aureus (MSSA); Methicillin-Resistant Staphylococcus Aureus (MRSA); Infection - Other infectious diseases

• Registration Number: ACTRN12617001416381
• Lead Sponsor: Menzies School of Health Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-06
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age – both children and adults will be eligible. Infants must have a corrected age of greater than or equal to 28 days.
2.S. aureus cultured from at least one clinically relevant specimen (Including an isolation in a polymicrobial culture when the other isolates are determined by the PI to be non-significant)
3.Able to be randomised within 72 hours of index culture
4.Likely to remain as inpatient for at least 7 days following randomisation (or is accessible for follow up by the site Principal Investigator. eg Hospital in the home (HITH)
5.Index culture drawn no later than 48 hours after hospital admission
6.Severe disease – at least one of
6.1Septic shock (including Staphylococcal toxic shock syndrome)
6.2Necrotising lung/pleural space infection
6.3Complicated skin/soft tissue/osteoarticular infection which is multifocal and non-contiguous [e.g. pyomyositis, non-contiguous multifocal pyogenic skin infection (abscess/carbuncle)]

Exclusion Criteria

1.Previous severe allergic reaction to both flucloxacillin and cefazolin (for MSSA), or to both vancomycin and daptomycin (for MRSA), or to lincosamides
2.Previous participation in the trial
3.Known pregnancy
4.Currently receiving a lincosamide or other potentially anti-toxin antibiotic which cannot be ceased or substituted
5.Participant’s primary clinician unwilling to enrol patient
6.Moribund (expected to die in next 24 hours with or without treatment)
7.Treatment limitations which preclude the use of antibiotics
8.Significant immunosuppression (Prednisolone >0.5mg per kg per day for greater than or equal to 14 days in the last 30 days, other immunosuppressive medication, known human immunodeficiency virus (HIV) with CD4 count<200 cells/microlitre, congenital immunodeficiency)
9.Necrotising fasciitis
10.Current clostridium difficile associated diarrhoea or severe diarrhoea from any cause

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of days alive and free of systemic inflammatory response syndrome (SIRS) within the first 14 days post randomisation.<br>SIRS criteria:<br>1.Abnormal temperature (less than 36 or greater than 38 degrees centigrade)<br>2.Tachypnoea or mechanical ventilation (RR greater than 20 per minute in an adult, age dependent in children)<br>3.Tachycardia (HR greater than 90 beats per minute in an adult, age dependent in children) <br>4.Abnormal leucocyte count (using last observation carried forward from any full blood count)<br>Age-appropriate cut-offs will be used for those aged less than 16 years<br>[Within the first 14 days post randomisation];Feasibility[Feasibility defined as the ability to recruit the target sample size within 2 years.]