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NCT Number: NCT01041716

Clinical and Microbiological Outcomes of Infections Due to Carbapenem-Resistant Gram-Negative Bacteria

Carbapenems are a class of antibiotic agents which kill a broad spectrum of bacteria. Infections due to gram-negative bacteria which have acquired resistance to carbapenems are increasing, especially with Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa . The optimal treatment of such infections is not known. Antibiotics like polymyxin, tigecycline and rifampin are used alone or in combination with other antibiotics. The outcome of using these new and old drugs is not well studied. This observational study aims to study the clinical and microbiological outcomes of these infections and treatment at our institution.

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Key information

Conditions

Drug Resistance, Microbial Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Pseudomonas Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

About this study

Objectives

  • To define the demographic and risk factor profile of patients acquiring CRGNB infection.
  • To define the characteristics of CRGNB infection.
  • To report the different treatments employed for CRGNB infection.
  • To report the microbiological and clinical outcomes of different treatment options
  • a. Microbiological outcomes: frequency of microbiological success. Microbiological success will be defined as two successive negative cultures from the same site as from where the CRGNB was originally isolated.
  • b. Clinical outcomes: clinical success (clinical cure), adverse effects of treatment especially the nephrotoxicity in relation to the use of polymyxin, ICU length of stay (if applicable), hospital length of stay, ICU mortality (if applicable), hospital mortality and in-hospital recurrence of infection. Clinical success will be defined as resolution or improvement of clinical symptoms and signs of infection and discontinuation of the antibiotics.

Study duration:

We plan to collect the data for a one year period. Based on the current prevalence rate at our institution, we anticipate having data for 300 patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult in-patients (age≥18 years) having an infection due to CRGNB (Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa only). CRGNB Infection will be defined as isolation of CRGNB from any source requiring treatment with anti-infective agents with or without manifestations of systemic inflammatory response syndrome.

Exclusion criteria

  • Patients colonized with CRGNB and not having an active infection.
  • Recurrent infection in a previously included patient.

Treatment and study plan

None - observational study

Other

None - Observational study

Primary outcomes

  1. Clinical success

    Time frame: At the end of treatment

    Resolution (or improvement) of clinical symptoms and signs of infection and discontinuation of the antibiotics.

Secondary outcomes

  1. Microbiological success

    Time frame: At the end of treatment

    Two successive negative cultures from the same site as the original pathogen was isolated.

  2. Recurrence rate

    Time frame: During the hospital stay

    Recurrence of symptoms and signs of infection from the same organism and reinstituion of antibiotic therapy

  3. Adverse effects of treatment

    Time frame: During treatment with antibiotics

    Adverse effects related to antibiotic administration, especially nephrotoxic and neurotoxic effects of polymyxin

  4. Hospital length of stay

    Time frame: During the hospital stay

    Number of days hospitalized

  5. Mortality

    Time frame: During hospital stay

    All cause mortality during hospital stay

Sponsors and collaborators

Lead sponsor

Maimonides Medical Center

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 1, 2010
Registry last updated
Aug 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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