Evaluating a Novel Individualised Treatment Strategy for Carbapenem-Resistant Gram-Negative Bacte… (NCT04202861) | Clinical Trial Compass
UnknownNot Applicable
Evaluating a Novel Individualised Treatment Strategy for Carbapenem-Resistant Gram-Negative Bacteria Infections
Singapore594 participantsStarted 2019-07-08
Plain-language summary
Carbapenem-resistant (CR) Gram negative bacteria (GNB) - which are resistant to carbapenems (a last-line potent antibiotic with a high therapeutic index) - are also resistant to all other beta-lactam antibiotics. Most CRGNB are also extensively-drug resistant (XDR) (resistant to all classes of antibiotics except polymyxins and/or tigecycline) or pan-drug resistant (PDR) (resistant to all antibiotics), resulting in a dearth of effective options against these life-threatening infections.
Against CRGNB, standard therapy includes monotherapy (using polymyxins or tigecycline) or unguided antibiotics combination (polymyxins + carbapenem). Unfortunately, CRGNB can develop resistance after antibiotic monotherapy, resulting in the further development of pan-drug resistance. Unguided antibiotic combinations, selected anecdotally based on past experience, are also unlikely to be useful in our local setting, as effective antimicrobial combinations are bacterial-strain specific due to large variation in molecular mechanisms of resistance.Hence, the investigators propose to evaluate the efficacy of a novel treatment strategy using in vitro antibiotic combination testing (iACT) to guide antibiotic combinations in the management of patients with CRGNB infections in a randomised controlled trial (RCT).
Who can participate
Age range16 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Inpatient at the time of enrolment.
✓. Age ≥16 years.
✓. An ongoing infection as defined by the published Centers for Disease Control and Prevention (CDC) /National Healthcare Safety Network (NHSN) or Infectious Diseases Society of America (IDSA) guidelines; Section 16.1-16.6 Appendix specifies the most common examples expected in this study.
✓. Positive culture of CRGNB isolates from relevant clinical sites (i.e. samples that are not obtained for surveillance purposes, such as rectal swabs)
✓. No more than 5 calendar days has elapsed since the first positive culture collection.
Exclusion criteria
✕. Unable to provide consent AND have no legal representative (LR).
✕. Subjects on palliative care or with less than 24 hours of life expectancy (as discussed with their primary physicians).
✕. Colonisation only, which is defined as positive isolation of CRGNB isolated at screening sites (e.g., rectal swabs) only
What they're measuring
1
30-day all cause mortality rate post therapy initiation after randomization