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

NCT ID: NCT01374256

Last Updated: 2011-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-07-31

Brief Summary

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.

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

Conditions

Acinetobacter Bacteraemia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Combination therapy

Patients with Acinetobacter baumannii bacteremia treated with combination therapy of imipenem and sulbactam

No interventions assigned to this group

Not combination therapy

Patients with Acinetobacter baumannii bacteremia not treated with combination therapy of imipenem and sulbactam

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Division of Infectious Diseases, Department of Medicine, Taipei Veterans General Hospital

Principal Investigators

Te-Li Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

Taipei Veterans General Hospital, Taiwan

Taipei, Taiwan, Taiwan

Countries

Taiwan

Central Contacts

Te-Li Chen, PhD

Role: CONTACT

tecklayyy@gmail.com

886228712121 ext. 7494

Shu-Chen Kuo

Role: CONTACT

ludwigvantw@gmail.com

886228712121 ext. 7494

Other Identifiers

201012032ID

Identifier Type: OTHER

Identifier Source: secondary_id

ISP 38889

Identifier Type: -

Identifier Source: org_study_id