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Acinetobacter InfectionsNCT02482961

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

An observational study of Acinetobacter Infections, run by DongGuk University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acinetobacter Infections
What is being tested?
colistimethate sodium
How many people
30 participants
Where
1 siteSouth Korea
Study dates
May 2015to 4 Apr 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Dongguk University Ilsan Hospital

    Goyang, Kyonggido, 411-773

Other trials in South Korea

About this study

Official title: Prospective Observational Study, Impact of Plasma Levels of Colistin in Patients With Carbapenem Resistant Acinetobacter Baumannii Infection

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.

Read the detailed description

Acinetobacter baumanii usually causes pneumonia and sepsis, and is susceptible to antibiotics such as ampicillin/sulbactam and carbapenem, but it easily becomes tolerant and there are few other drugs usable. Particularly in Korean patients with ventilator-associated pneumonia (VAP), the percentage of carbapenem-resistant Acinetobacter baumannii (CRAB) is increasing recently.

Colistin (polymyxin E) is antibiotic of polymyxin line used to multidrug-resistant gram-negative bacteria such as Klebsiella pneumonia, Pseudomonas aeruginosa, and Acinetobacter baumannii, and it produces bactericidal action by destroying bacterial cell membrane. Colistin was antibiotic isolated from Bacillius polymyxa subspecies colistinus first in Japan in 1949, and has long been used in clinic since 1959, but its use through intravenous infusion decreased in the 1970s due to acute kidney injury and neurotoxicity. Recently, however, it is being used more frequently for hospital infection by multidrug-resistant gram-negative bacteria and, as a result, various studies are being conducted on colistin.

Colistin consists of over 30 different polymyxin compounds including colistin A (polymyxin E1) and colistin B (polymyxin E2), and colistimethate sodium (CMS) and colistin sulfate are used. In Korea, it is usually administered intravenously in the form of CMS, which is an inactive precursor. In the body, CMS is metabolized into various metabolites including colistin or is discharged through urine. In contrast, active metabolite colistin is hardly discharged through urine, and is removed through non-renal elimination, but the accurate extracorporeal elimination mechanism is still unknown. CMS reaches the peak serum concentration in 10 minutes from intravenous administration, and its half-life is 2.2 hours while the half-life of colistin 18.5 hours.

With regard to the bactericidal activity of colistin, the unbound area under the concentration-time curve/minimum inhibitory concentration (fAUC/MIC) is important, and adequate exposure to the drug has been known to be important for curative effect, but it is still controversial what the optimal dose and interval are. Although the drug has been used long, the accurate measuring of colistin blood concentration became possible only in the mid 2000s and, therefore, pharmacokinetic research on the drug has been conducted relatively recently and there is increasing interest in the validity of established uses, adequate uses, therapeutic drug monitoring, etc. Two of the established uses of the drug are intravenous administration of 2.5~5mg/kg/day divided into 2~4 times to patients with normal renal function, adjusting the dose and interval of administration according to renal function (package insert), and the administration of loading dose followed by 2~3 times of administration depending on renal function. The major side effects of colistin are nephrotoxicity and neurotoxicity, and according to a recent study, the incidence of nephrotoxicity caused by colistin was 30~60%. Renal insufficiency is more frequent when vancomycin is used together in VAP. Renal insufficiency is known to be reversible, but some cases require dialysis. Known risk factors of renal insufficiency include cumulative CMS dose, combined use of drugs inducing renal insufficiency, female, and age.

There have been ex vivo studies for assessing the bactericidal effect of colistin for exploring its adequate uses and case studies for evaluating the risk factors of nephrotoxicity, one of the major side effects yet there are still controversial issues related to the drug. Furthermore, as most of these studies were conducted with Western subjects, their results are hardly applicable to Koreans as they are. Thus, this study purposed to examine the adequate range of therapeutic concentration for Korean people.

Being tested
colistimethate sodium
Medical subject headings
Acinetobacter Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • colistimethate sodiumDrug

    Also called colistin

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Difference in plasma drug concentration between patients showing clinical cure or improvement and those of treatment failure

    Criteria for clinical cure/improvement:

    • Clinical cure: The symptoms and signs of infection have disappeared completely at the end of treatment.
    • Clinical improvement: The symptoms and signs of infection have disappeared partially at the end of treatment.

    Measured: 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.

  2. Difference in plasma drug concentration according to microbiological response

    • Microbiological response: Pathogens are not cultured at the end of treatment.

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

  3. Difference in plasma drug concentration according to in-hospital mortality

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

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

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

  5. Risk factors associated with nephrotoxicity

    Use of NSAIDS or other antibiotics, age and sex etc. associated with nephrotoxicity will be analyzed.

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

  6. Difference in plasma drug concentration between patients with abnormality of liver function.

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

  7. Difference in plasma drug concentration between patients with abnormality of thrombocytopenia.

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

  8. Difference in plasma drug concentration between patients with abnormality of neuropathy.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2015 (estimated)
  2. Study startMay 2015
  3. Primary completion10 Jan 2018
  4. Study completion4 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02482961
Sponsor's protocol ID
2014-128
Status last verified
Jun 2018
First submitted
3 Jun 2015
Last updated
26 Jun 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34775134

Questions about this trial

What is this clinical trial studying?

An observational study of Acinetobacter Infections, run by DongGuk University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in plasma drug concentration between patients with nephrotoxicity and those without (time frame: Participants will be followed for the duration of hospital stay, an expected average of 2-3wks. Nephrothoxicity was determined during colistin use.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02482961, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.

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