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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maimonides Medical Center
ClinicalTrials.gov Identifier:
NCT01041716
First received: December 30, 2009
Last updated: August 18, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Drug Resistance, Microbial
Other: None - Observational study

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical and Microbiological Outcomes of Infections Due to Carbapenem-Resistant Gram-Negative Bacteria

Resource links provided by NLM:


Further study details as provided by Maimonides Medical Center:

Primary Outcome Measures:
  • Clinical success [ Time Frame: At the end of treatment ] [ Designated as safety issue: No ]
    Resolution (or improvement) of clinical symptoms and signs of infection and discontinuation of the antibiotics.


Secondary Outcome Measures:
  • Microbiological success [ Time Frame: At the end of treatment ] [ Designated as safety issue: Yes ]
    Two successive negative cultures from the same site as the original pathogen was isolated.

  • Recurrence rate [ Time Frame: During the hospital stay ] [ Designated as safety issue: Yes ]
    Recurrence of symptoms and signs of infection from the same organism and reinstituion of antibiotic therapy

  • Adverse effects of treatment [ Time Frame: During treatment with antibiotics ] [ Designated as safety issue: Yes ]
    Adverse effects related to antibiotic administration, especially nephrotoxic and neurotoxic effects of polymyxin

  • Hospital length of stay [ Time Frame: During the hospital stay ] [ Designated as safety issue: Yes ]
    Number of days hospitalized

  • Mortality [ Time Frame: During hospital stay ] [ Designated as safety issue: Yes ]
    All cause mortality during hospital stay


Estimated Enrollment: 300
Study Start Date: December 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: None - Observational study
    None - Observational study
    Other Name: None - Observational study
Detailed Description:

Objectives

  1. To define the demographic and risk factor profile of patients acquiring CRGNB infection.
  2. To define the characteristics of CRGNB infection.
  3. To report the different treatments employed for CRGNB infection.
  4. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult in-patients (age≥18 years) having an infection due to CRGNB (Klebsiella pneumoniae, Acinitobacter baumanii 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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041716

Locations
United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Maimonides Medical Center
Investigators
Principal Investigator: Sriharsha Rao, M.D. Maimonides Medical Center
  More Information

Publications:
Responsible Party: Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT01041716     History of Changes
Other Study ID Numbers: 09/11VA03
Study First Received: December 30, 2009
Last Updated: August 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Maimonides Medical Center:
Carbapenem
Klebsiella pneumoniae carbapenemase
Acinetobacter baumannii
Pseudomonas aeruginosa

ClinicalTrials.gov processed this record on November 20, 2014