NCT02365493: CAMERA2

Combination Antibiotic Therapy for Methicillin Resistant Staphylococcus Aureus Infection

Terminated Phase 3 Last updated 19 December 2018

What this trial tests

Phase 3 trial testing Beta-Lactam in Methicillin-Resistant Staphylococcus Aureus in 358 participants. Terminated before completion.

Timeline

26 August 2015

Primary endpoint
24 October 2018

24 October 2018

Quick facts

Lead sponsor	Menzies School of Health Research
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	358
Start date	26 August 2015
Primary completion	24 October 2018
Estimated completion	24 October 2018
Sites	30 locations across New Zealand, Singapore, Israel, Australia

Drugs / interventions tested

• Beta-Lactam — full drug profile →

Conditions studied

• Methicillin-Resistant Staphylococcus Aureus — all drugs for Methicillin-Resistant Staphylococcus Aureus →

Sponsor

Menzies School of Health Research

Who can join

18 and older, any sex, with Methicillin-Resistant Staphylococcus Aureus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this clinical trial is to determine whether a novel combination antibiotic treatment (vancomycin/daptomycin + beta-lactam) is superior to the standard antibiotic treatment (vancomycin/daptomycin) for hospitalised adults with Methicillin Resistant Staphylococcus aureus bacteraemia. The hypothesis is that the addition of beta-lactam antibiotics (these are antibiotics from the penicillin family) to the standard therapy will lead to more efficient bacterial killing and hence lead to faster clearance of bacteria from the blood stream and other areas of infection, thereby reducing the risk of the spread of infection and death.

The study design is an investigator-initiated, multi-centre, open-label, randomised controlled trial. This will include 440 participants diagnosed with Methicillin Resistant Staphylococcus aureus bacteraemia recruited over a period of 4 years (July 2015 - June 2019) from within Infectious Diseases inpatient units across 21 hospital sites including 18 from within Australia and 3 located in Singapore. Participation will be voluntary and subject to informed consent. The participants will be randomised 1:1 to either the standard therapy group or combination therapy group. The combination therapy will include a treatment of intravenous beta-lactam for the first 7 days of treatment, in addition to the standard treatment (either vancomycin or daptomycin). The primary outcome measure will be complication-free survival 90 days post randomisation.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Incidence, prevalence, and management of MRSA bacteremia across patient populations-a review of recent developments in MRSA management and treatment.
   Hassoun A, Linden PK, Friedman B. · · 2017 · cited 364× · PMID 28807042 · DOI 10.1186/s13054-017-1801-3
2. Effect of Vancomycin or Daptomycin With vs Without an Antistaphylococcal β-Lactam on Mortality, Bacteremia, Relapse, or Treatment Failure in Patients With MRSA Bacteremia: A Randomized Clinical Trial.
   Tong SYC, Lye DC, Yahav D, Sud A, et al · · 2020 · cited 210× · PMID 32044943 · DOI 10.1001/jama.2020.0103
3. CAMERA2 - combination antibiotic therapy for methicillin-resistant Staphylococcus aureus infection: study protocol for a randomised controlled trial.
   Tong SY, Nelson J, Paterson DL, Fowler VG, et al · · 2016 · cited 53× · PMID 27029920 · DOI 10.1186/s13063-016-1295-3
4. Appropriate endpoints for evaluation of new antibiotic therapies for severe infections: a perspective from COMBACTE's STAT-Net.
   Timsit JF, de Kraker MEA, Sommer H, Weiss E, et al · · 2017 · cited 51× · PMID 28466147 · DOI 10.1007/s00134-017-4802-4
5. The Combination of Daptomycin and Fosfomycin Has Synergistic, Potent, and Rapid Bactericidal Activity against Methicillin-Resistant Staphylococcus aureus in a Rabbit Model of Experimental Endocarditis.
   García-de-la-Mària C, Gasch O, García-Gonzalez J, Soy D, et al · · 2018 · cited 48× · PMID 29610194 · DOI 10.1128/aac.02633-17
6. Considerations for Clinical Trials of Staphylococcus aureus Bloodstream Infection in Adults.
   Holland TL, Chambers HF, Boucher HW, Corey GR, et al · · 2019 · cited 32× · PMID 30202941 · DOI 10.1093/cid/ciy774
7. Investigational agents for the treatment of methicillin-resistant <i>Staphylococcus aureus</i> (MRSA) bacteremia: progress in clinical trials.
   Burgin DJ, Liu R, Hsieh RC, Heinzinger LR, et al · · 2022 · cited 8× · PMID 35129409 · DOI 10.1080/13543784.2022.2040015
8. Risk Factors for Nephrotoxicity in Methicillin-Resistant Staphylococcus aureus Bacteraemia: A Post Hoc Analysis of the CAMERA2 Trial.
   Legg A, Meagher N, Johnson SA, Roberts MA, et al · · 2023 · cited 6× · PMID 36217068 · DOI 10.1007/s40261-022-01204-z