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Status unknownNCT01374256Updated Jun 15, 2011

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

An observational study in Acinetobacter Bacteraemia, sponsored by Taipei Veterans General Hospital, Taiwan. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-15.

Sponsored by Taipei Veterans General Hospital, Taiwan · Observational

The sponsor has not verified this record recently (last verified Jun 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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

02

Conditions studied

  • Acinetobacter Bacteraemia

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Keywords

  • carbapenem
  • sulbactam
  • Acinetobacter baumannii
03

In context

Bacteremia

322 studies on the registry are indexed under Bacteremia; 49 are open to participants now.

This study's planned enrollment of 200 is below the median of 269 across 133 observational studies indexed under Bacteremia.

Browse Bacteremia studies →

Lead sponsor

Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

  • pregnancy or lactation in women
  • history of serious allergy or intolerance to study drug therapy
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Biospecimen retention
Samples without dna

Groups and 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

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What researchers measure

Primary outcomes

  1. survival rate

    Time frame: 14 days

Secondary outcomes

  1. survival rate

    Time frame: 28 days

07

Study locations

1 site
  • Taipei Veterans General Hospital, Taiwan
    Taipei, 112, Taiwan
    • Te-li Chen, PhD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01374256
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
Merck Sharp & Dohme LLC
First posted
Jun 15, 2011
Start date
Jul 2011
Primary completion
Jul 2013 (estimated)
Completion
Jul 2013 (estimated)
Last update
Jun 15, 2011

Study contacts

Te-Li Chen, PhD
Contact
tecklayyy@gmail.com
886228712121 ext. 7494
Shu-Chen Kuo
Contact
ludwigvantw@gmail.com
886228712121 ext. 7494
Te-Li Chen, PhD
principal investigator · Taipei Veterans General Hospital, Taiwan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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