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

NCT01041716 | Completed

• 1 other identifier: 09/11VA03
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Drug Resistance, Microbial

Keywords

Carbapenem; Klebsiella pneumoniae carbapenemase; Acinetobacter baumannii; Pseudomonas aeruginosa

Outcome Measures

Primary Outcomes (1)

• Clinical success

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

  At the end of treatment

Secondary Outcomes (5)

• Microbiological success

  At the end of treatment

• Recurrence rate

  During the hospital stay

• Adverse effects of treatment

  During treatment with antibiotics

• Hospital length of stay

  During the hospital stay

• Mortality

  During hospital stay

Interventions

None - Observational study OTHER

None - Observational study

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

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Maimonides Medical Center: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (5)

• Bradford PA, Bratu S, Urban C, Visalli M, Mariano N, Landman D, Rahal JJ, Brooks S, Cebular S, Quale J. Emergence of carbapenem-resistant Klebsiella species possessing the class A carbapenem-hydrolyzing KPC-2 and inhibitor-resistant TEM-30 beta-lactamases in New York City. Clin Infect Dis. 2004 Jul 1;39(1):55-60. doi: 10.1086/421495. Epub 2004 Jun 14.

  PMID: 15206053 BACKGROUND

• Bratu S, Landman D, Haag R, Recco R, Eramo A, Alam M, Quale J. Rapid spread of carbapenem-resistant Klebsiella pneumoniae in New York City: a new threat to our antibiotic armamentarium. Arch Intern Med. 2005 Jun 27;165(12):1430-5. doi: 10.1001/archinte.165.12.1430.

  PMID: 15983294 BACKGROUND

• Patel G, Huprikar S, Factor SH, Jenkins SG, Calfee DP. Outcomes of carbapenem-resistant Klebsiella pneumoniae infection and the impact of antimicrobial and adjunctive therapies. Infect Control Hosp Epidemiol. 2008 Dec;29(12):1099-106. doi: 10.1086/592412.

  PMID: 18973455 BACKGROUND

• Weisenberg SA, Morgan DJ, Espinal-Witter R, Larone DH. Clinical outcomes of patients with Klebsiella pneumoniae carbapenemase-producing K. pneumoniae after treatment with imipenem or meropenem. Diagn Microbiol Infect Dis. 2009 Jun;64(2):233-5. doi: 10.1016/j.diagmicrobio.2009.02.004. Epub 2009 Apr 2.

  PMID: 19345034 BACKGROUND

• Bratu S, Tolaney P, Karumudi U, Quale J, Mooty M, Nichani S, Landman D. Carbapenemase-producing Klebsiella pneumoniae in Brooklyn, NY: molecular epidemiology and in vitro activity of polymyxin B and other agents. J Antimicrob Chemother. 2005 Jul;56(1):128-32. doi: 10.1093/jac/dki175. Epub 2005 May 25.

  PMID: 15917285 BACKGROUND

MeSH Terms

Conditions

Pseudomonas Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Sriharsha Rao, M.D.

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 30, 2009
• First Posted: January 1, 2010
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 19, 2011

Record last verified: 2011-08

Locations

US (1)