Impact of Plasma Levels of Colistin in Patients With Carbapenem Resistant Acinetobacter Baumannii Infection

NCT02482961 | Completed DMC

• 1 other identifier: 2014-128
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study purposed to examine the adequate range of therapeutic concentration for Korean people by observing curative effects, side effects, blood concentration, etc. in treating CRAB-infected patients with colistin.

Conditions

Acinetobacter Infections

Outcome Measures

Primary Outcomes (1)

• Difference in plasma drug concentration between patients with nephrotoxicity and those without

  \- Criteria for diagnosing nephrotoxicity: Creatinine clearance (CrCL) decreases to 50% of the baseline value or serum creatinine concentration (SCr) doubles, or renal replacement therapy is required.

  Participants will be followed for the duration of hospital stay, an expected average of 2-3wks. Nephrothoxicity was determined during colistin use.

Secondary Outcomes (8)

• Difference in plasma drug concentration between patients showing clinical cure or improvement and those of treatment failure

  Participants will be followed for the duration of hospital stay, an expected average of 2-3wks. Clinical outcome was determined at the final day of colistin use.

• Difference in plasma drug concentration according to microbiological response

  Participants will be followed for the duration of hospital stay, an expected average of 2-3wks.

• Difference in plasma drug concentration according to in-hospital mortality

  Participants will be followed for the duration of hospital stay, an expected average of 2-5wks.

• Difference in plasma drug concentration according to the RIFLE Criteria for nephrotoxicity

  Participants will be followed for the duration of hospital stay, an expected average of 2-3wks.

• Risk factors associated with nephrotoxicity

  Participants will be followed for the duration of hospital stay, an expected average of 2-3wks.

Interventions

colistimethate sodium DRUG

At least once a week, all patients with carbapenem-resistant Acinetobacter baumannii infection were screened from the database at the clinical microbiology laboratory

Also known as: colistin

Eligibility Criteria

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

Study Population

All adult patients (aged ≥18 years)had Microbiological evidence (sputum, urine, blood) of infection due to carbapenem-resistant Acinetobacter baumannii result during the study period at Dongguk University Ilsan Hospital

You may qualify if:

• All adult patients (aged ≥18 years)
• Microbiological evidence (sputum, urine, blood) of infection due to carbapenem-resistant Acinetobacter baumannii during hospitalization
• Intravenous Colistimethate sodium treated patient with Acinetobacter baumannii infection who fulfill the above criteria
• Patients who agree to the gathering clinical information by means of an informed consent

You may not qualify if:

• Pregnancy and lactating women
• Patients receiving Colistimethate sodium therapy for \<48 hours
• Patient of chronic renal disease defined as a Creatinine clearance \<10 mL/min, Or requirement for peritoneal or hemo-dialysis or hemofiltration
• Known hypersensitivity to Colistimethate sodium
• Receiving intravenous colistin therapy within the past 30 days
• Patients treated with nebulized Colistimethate sodium

Sponsors & Collaborators

• DongGuk University: lead

Study Sites (1)

Dongguk University Ilsan Hospital

Goyang, Kyonggido, 411-773, South Korea

Location

Related Publications (1)

• Jeong YJ, Gu N, Kwack WG, Kang Y, Park SY, Yoon YS. Prospective observational study of the impact of plasma colistin levels in patients with carbapenem-resistant Acinetobacter baumannii pneumonia. J Glob Antimicrob Resist. 2021 Dec;27:315-323. doi: 10.1016/j.jgar.2021.10.017. Epub 2021 Nov 12.

  PMID: 34775134 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Acinetobacter Infections

Interventions

colistinmethanesulfonic acid; Colistin

Condition Hierarchy (Ancestors)

Moraxellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins

Study Officials

• Young-Soon Yoon, professor

  DongGuk University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 26, 2015
• Study Start: May 1, 2015
• Primary Completion: January 10, 2018
• Study Completion: April 4, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

KR (1)