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Comparison of Bloodstream Infections With Carbapenem Hetero-resistant vs Carbapenem Resistant Klebsiella Pneumoniae

NCT04229498 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2020-01-18

No results posted yet for this study

Summary

COMBAT trial was contemplated to elucidate unknown clinical relevance of carbapenem heteroresistance among Klebsiella pneumoniae species. Bloodstream infections, type of frequently seen invasive infections that pathogen isolation, identification of antimicrobial resistance mechanisms can be performed efficiently, with carbapenem resistant Klebsiella pneumoniae (CRKp) and carbapenem hetero-resistant Klebsiella pneumoniae will be compared in terms of relevant clinical outcomes such as 30-day mortality rate, 14-day clinical cure rate, 7-day microbiological eradication rate and 90-day relapse/re-infection rate. In addition, underlying molecular resistance mechanisms causing carbapenem hetero-resistance among Klebsiella pneumoniae isolates will be investigated by using whole genome sequences.

Conditions

  • Bloodstream Infection

Interventions

DRUG

Monotherapy and combination therapy (all antibiotics that are given by attending pysicians and can be active against Klebsiella pneumoniae will be evaluated)

In carbapenem heteroresistant Klebsiella pneumoniae group, carbapenem monotherapy (ertapenem, imipenem, meropenem) vs other treatment groups will also be compared

Sponsors & Collaborators

  • SCARE (Study group for carbapenem resistance)

    lead OTHER

Principal Investigators

  • Abdullah T Aslan, Dr. · Hacettepe University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2021-04-30
Completion
2021-11-30

Countries

  • Turkey (Türkiye)

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 NCT04229498 on ClinicalTrials.gov