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Time to antibiotic modification among patients with multidrug resistant gram-negative bacilli bloodstream infections between rapid carbapenemase detection by lateral flow immunochromatography assay and conventional blood culture

Time to antibiotic modification among patients with multidrug resistant gram-negative bacilli bloodstream infections between rapid carbapenemase detection by lateral flow immunochromatography assay and conventional blood culture

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251011002
Enrollment
180
Registered
2025-10-11
Start date
2025-11-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with gram-negative bacilli bloodstream infection multidrug resistant, gram negative bacilli, blood stream infections, rapid diagnostic test, time to treatment

Interventions

1.Positive gram-negative bacilli blood cultures are subsequently tested using the O.K.N.V.I. RESIST-5 assay (rapid test) to detect the presence of OXA-48, KPC, NDM, VIM, and IMP carbapenemases 2.The r
inpatient wards via telephone and documented in the electronic medical record 3.A recommended antibiotic modification sheet is provided to each ward
however, the decision to adjust antimicrobial therapy depends on the attending physicians, reflecting a pragmatic, real-world approach,1.Positive gram-negative bacilli blood culture results will be re
inpatient wards via telephone and documented in the electronic medical record No rapid carbapenemase test will be done 2. The decision to adjust antimicrobial therapy depends on the attending physicia
Experimental Device,No Intervention No treatment
Rapid lateral flow immunochromatographic assay (RESIST-5 O.K.N.V.I.),Standard of care

Sponsors

Natwadee Mungkarndee
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older 2. Positive gram negative bacilli from hemoculture at least 1 bottle 3. Admitted to one of the 12 inpatient wards at Bhumibol Adulyadej Hospital; including the Intensive Care Unit (ICU), Semi-ICU, internal medicine, surgical, and orthopedic ward, all of which have a documented history of patients with multidrug-resistant gram-negative bacilli bloodstream infections in previous years

Exclusion criteria

Exclusion criteria: 1.The patient was receiving palliative care at the time of randomization 2.The patient refused to participate in the study] 3.The patient underwent other previous researches that affect hemoculture

Design outcomes

Primary

MeasureTime frame
Time to antibiotic modification within 72 hours Time (in hours) measured from the moment a gram stain result reports gram-negative bacilli from hemoculture to the time the patient receives an appropriate antimicrobial modification

Secondary

MeasureTime frame
Hazard rate of appropriate antibiotics adjustment within 72 hours Univariate, Multivariate regression analysis, using Log-rank test ,30-day all-cause mortality 30 days Count,Hospital Length of stay - Count,ICU length of stay - Count,Rate of C.difficile infection or MDRO infections 30 days Count,Baseline characteristics at enrollment, within 24 hour Univariate, Multivariate regression analysis

Countries

Thailand

Contacts

Public ContactNatwadee Mungkarndee

Bhumibol Adulyadej Hospital

natwadee_mun@rtaf.mi.th6625347340

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026