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Evaluating a Novel Individualised Treatment Strategy for Carbapenem-Resistant Gram-Negative Bacteria Infections

NCT04202861 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 594

Last updated 2021-10-08

No results posted yet for this study

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).

Conditions

  • Antibiotic Therapy

Interventions

DIAGNOSTIC_TEST

In vitro antibiotic combination testing (iACT)

CRGNB isolates from the index culture will be transported to the Pharmacy Research Lab,SGH for iACT testing. iACT results will be sent to the physicians and ID specialist managing the patient once completed. A subset of results will be published in the iACT report. Participants enrolled into the intervention arm -should ideally be kept on an iACT combination for the required treatment period. However during the treatment period, the treating doctor-in-charge and or the consulting infectious disease doctor may wish to continuing iACT antibiotic combination therapy or modifying the combinations based on their best clinical judgement for the patient.

Sponsors & Collaborators

  • National Medical Research Council (NMRC), Singapore

    collaborator OTHER_GOV

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Andrea LH Kwa, PharmD · Singapore General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-08
Primary Completion
2022-09-30
Completion
2023-03-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04202861 on ClinicalTrials.gov