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

NCT04229498 | Unknown

• 1 other identifier: COMBAT121219
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Carbapenem resistant Klebsiella pneumoniae; Carbapenem heteroresistant Klebsiella pneumoniae; Bloodstream Infections; Sepsis; Septic shock; Relapses/re-infections; Mortality

Outcome Measures

Primary Outcomes (1)

• 30-day crude mortality

  Death by any cause

  30-day

Secondary Outcomes (2)

• 14-day clinical response

  14-days

• 90-day relapse or re-infection

  90-days

Other Outcomes (2)

• 7-day microbiological eradication

  7-day

• Resistance genes

  90 days

Study Arms (2)

Carbapenem resistant Klebsiella pneumoniae group

Participants having bloodstream infection caused by carbapenem-resistant Klebsiella pneumoniae and systemic signs of infection. Only first bloodstream infection episode will be included for each participant

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

Carbapenem hetero-resistant Klebsiella pneumoniae group

Participants having bloodstream infection caused by carbapenem-heteroresistant Klebsiella pneumoniae and systemic signs of infection. Only first bloodstream infection episode will be included for each participant

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

Interventions

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

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

Also known as: Drug

Carbapenem hetero-resistant Klebsiella pneumoniae group; Carbapenem resistant Klebsiella pneumoniae group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult (≥18 years) patients who have monobacterial BSI with CRKp or carbapenem hetero-resistant Klebsiella pneumoniae and treated by infectious diseases specialist will be inculded except palliative patients and pregnant or breast-feeding patients. Participants having polimicrobial BSI episode (more than 1 microorganism identified in blood culture) and subsequent BSI episodes caused by CRKp or carbapenem heteroresistant Klebsiella pneumoniae will be excluded.

You may qualify if:

• All adult (≥18 years) patients who have monobacterial BSI with CRKp or carbapenem hetero-resistant Klebsiella pneumoniae except palliative patients and pregnant or breast-feeding patients

You may not qualify if:

• \<18 years old patients
• Palliative patients
• Pregnant or breast-feeding patients
• Subsequent BSI episodes in the same patients (only first episode will be included)
• Polimicrobial bacteremia
• Patients who are not followed and treated by infectious diseases physicians
• Patients who die within 24 hours after onset of BSI which is defined as the time in which the sample for blood culture is taken.

Sponsors & Collaborators

• SCARE (Study group for carbapenem resistance): lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (17)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood culture samples of participants

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Combined Modality Therapy; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Abdullah T Aslan, Dr.

  Hacettepe University

  STUDY DIRECTOR

Central Study Contacts

Abdullah T Aslan, Dr.

CONTACT

+905346754889; aslanabdullahtarik@gmail.com

Murat Akova, Prof. Dr.

CONTACT

+905323151845; akova.murat@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2020
• First Posted: January 18, 2020
• Study Start: April 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: November 1, 2021
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)