Imipenem and Sulbactam in the Treatment of Imipenem-resistant Acinetobacter Baumannii Bacteremia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01374256
First received: June 14, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

Infections caused by imipenem-resistant Acinetobacter baumannii are associated with high mortality and morbidity. The treatment choices for this resistant pathogen are limited.

The objective of the present proposal is to evaluate the effectiveness of combination therapy of imipenem and sulbactam in patients contracted with A. baumannii, and to correlate the clinical effect with the in vitro synergistic results.


Condition
Acinetobacter Bacteraemia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Effectiveness of Imipenem and Sulbactam in the Treatment of Bacteremic Patients Contracted With Imipenem-resistant Acinetobacter Baumannii

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • survival rate [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • survival rate [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Acinetobacter baumannii isolates from the blood samples of patients


Estimated Enrollment: 200
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Combination therapy
Patients with Acinetobacter baumannii bacteremia treated with combination therapy of imipenem and sulbactam
Not combination therapy
Patients with Acinetobacter baumannii bacteremia not treated with combination therapy of imipenem and sulbactam

Detailed Description:

Acinetobacter baumannii has been increasingly reported in the outbreak of nosocomial infections in the intensive care units, which not only prolong the length of hospital stay but result in high attributable mortality. With its intrinsic resistance to many antimicrobial agents and rapid acquirement of resistance mechanism, resistance to carbapenems, which is often accompanied with resistance to multiple drugs, has emerged worldwide. The limited treatment choice included tigecycline, colistin, and sulbactam. However, the low serum level and bacteriostatic nature of tigecycline hamper its application in blood stream infection, one of the most common presentations of A. baumannii infections. The nephrotoxicity and neurotoxicity of intravenous colistin have caused great concerns in critically ill patients whereas immediate bronchospasm after inhalation and significant clinical consequences have been reported. Sulbactam has been used for decades in combination of ampicillin and well tolerated. However, the emergence of resistance strains and discourage of monotherapy in severely ill patients make combination an attractive choice. Combination of sulbactam and carbapenems has good synergism against A. baumannii with elevated minimal inhibitory concentration (MIC) of sulbactam and/or carbapenems while in an animal model using A. baumannii with higher MIC of both sulbactam and meropenem, survival rate was higher in combination group than sulbactam or meropenem-treated alone group. The similar in vivo bactericidal effect was also observed in combination of imipenem and sulbactam. Despite plenty of in vivo and in vitro studies mentioned above, the clinical studies were limited. Besides, the information regarding the correlation of in vitro synergistic effect of carbapenem and sulbactam with the clinical effect is rarely mentioned. Therefore, our study is aimed to evaluate the effectiveness of combination therapy of imipenem and sulbactam in patients contracted with A. baumannii, and to correlate the clinical effect with the in vitro synergistic results

  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

This retrospective study will be conducted at Taipei Veterans General Hospital, a 2900-bed tertiary care medical center in Taiwan. Patients elder than 18 years old are included if they have bloodstream infections due to A. baumannii regardless of primary infection sites.

Criteria

Inclusion Criteria:

  • elder than 18 years old are included if they have bloodstream infections due to A. baumannii regardless of primary infection sites

Exclusion Criteria:

  • pregnancy or lactation in women
  • history of serious allergy or intolerance to study drug therapy
  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: NCT01374256

Contacts
Contact: Te-Li Chen, PhD 886228712121 ext 7494 tecklayyy@gmail.com
Contact: Shu-Chen Kuo 886228712121 ext 7494 ludwigvantw@gmail.com

Locations
Taiwan
Taipei Veterans General Hospital, Taiwan Not yet recruiting
Taipei, Taiwan, 112
Principal Investigator: Te-li Chen, PhD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Te-Li Chen, PhD Taipei Veterans General Hospital, Taiwan
  More Information

No publications provided

Responsible Party: Te-li Chen, MD, PhD, Associate Professor, Division of Infectious Diseases, Department of Medicine, Taipei Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01374256     History of Changes
Other Study ID Numbers: ISP 38889, 201012032ID
Study First Received: June 14, 2011
Last Updated: June 14, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Veterans General Hospital, Taiwan:
carbapenem
sulbactam
Acinetobacter baumannii

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Sulbactam
Imipenem
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014