Study
Recruiting Not a phased study
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| St George Hospital | Kogarah | NSW | Recruiting |
| John Hunter Hospital | New Lambton | NSW | Recruiting |
| Royal Brisbane and Women's Hospital | Herston | QLD | Recruiting |
| Redcliffe Hospital | Redcliffe | QLD | Recruiting |
| Sunshine Coast University Hospital | Sunshine Coast | QLD | Recruiting |
| Monash Medical Center | Clayton | VIC | Recruiting |
| Fiona Stanley Hospital | Murdoch | WA | Recruiting |
| St John of God | Murdoch | WA | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
PLATFORM INCLUSION CRITERIA
Platform Inclusion Criteria:
* admitted to a participating hospital
* positive blood culture with Gram negative (GN) bacterium
Platform Exclusion Criteria:
* patient's goals of care are for palliation with no active treatment
* moribund patient, not expected to survive \> 72 hours
* previously enrolled in the platform trial
* not eligible for any domain at the time of screening
DOMAIN SPECIFIC INCLUSION AND EXCLUSION CRITERIA
1. De-escalation versus no de-escalation domain
Inclusion Criteria
\- included in BALANCE+ platform
Exclusion Criteria
* receiving an empiric antibiotic regimen at the time of blood culture finalization to which the GN pathogen(s) are not sensitive
* arbapenem-non-susceptible
* no de-escalation option due to any or all of:
* antimicrobial resistance
* allergies
* medical contraindications
* drug-drug interaction risk
* other relevant reason
* patients with a suspected or proven polymicrobial source of infection
* \> 24 hours since index blood culture susceptibility results finalization
2. Beta-lactam versus non-beta-lactam oral/enteral treatment domain
Inclusion Criteria
* included in BALANCE+ platform
* initially treated with intravenous antibiotics, but clinical team transitioning patient to oral/enteral antibiotic within 7 days of starting treatment
Exclusion Criteria
* enrolled in an arm of another BALANCE+ platform domain which limits the use of oral/enteral therapy:
* no-de-escalation arm (patients in the no de-escalation arm cannot be randomized into this domain unless they are ready for discharge home, in which case de-escalation is allowable to oral agents at discharge)
* no non-beta-lactam options due to any or all of:
* resistance
* allergies
* medical contraindications
* drug-interaction risk
* other relevant reason
* no beta-lactam options due to any or all of:
* resistance
* allergies
* medical contraindications
* drug-interaction risk
* other relevant reason
* pregnancy
* already received \>24 hours of oral antibiotics after index blood culture finalization
3. Central vascular catheter replacement domain
Inclusion Criteria
* included in BALANCE+ platform
* has an indwelling central vascular catheter that was already in place within the 48-hour period before the onset of bloodstream infection (i.e. is not a new catheter placed within 48 hours of the onset of infection)
Exclusion Criteria
* patient has no ongoing need for a central vascular catheter
* patient has definite indication for central vascular catheter removal
* ongoing septic shock with definite/probable line source
* concomitant S. aureus bacteremia
* concomitant candidemia
* local suppurative signs (severe redness, warmth, pain, swelling or fluctuance/collection) necessitating catheter removal, or other clinical evidence of infected line (e.g. imaging/echocardiographic findings)
4. Low-risk AmpC domain
Inclusion Criteria
* included in BALANCE+ platform
* positive blood culture with GN bacterium, of the following species: i. Serratia spp. ii Morganella spp. iii Providencia spp. iv Proteus spp. other than P.mirabilis
* organism is susceptible to ceftriaxone
Exclusion Criteria
* severe allergy to beta-lactams (e.g., type 4 hypersensitivity reaction or DRESS)
* baseline phenotypic non-susceptiblity to ceftriaxone
* more than 1 calendar day beyond availability of susceptibility results
5. Follow up blood culture domain
Inclusion Criteria
\- included in BALANCE+ platform
Exclusion Criteria
* patient died or discharged from hospital prior to day 4
* blood culture already collected by the treating team at day 4±1
* \>5 days since index positive blood culture collection
* definite indication for repeat blood culture testing
* concomitant S. aureus bacteremia
* concomitant Candidemia
* clinical suspicion for infective endocarditis
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 4 September 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.