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A Prospective Observational Study of Patients With Drug Resistant Acinetobacter Baumannii Bacteremia (ANTI-AB)

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ClinicalTrials.gov Identifier: NCT01511224
Recruitment Status : Unknown
Verified January 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : January 18, 2012
Last Update Posted : January 18, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Extensively and multi-drug resistant A. baumannii (AB) represent an emerging threat in hospitals locally and worldwide. There is lack of prospective comparative clinical data to guide optimal strategy for treating such infections. Since it remains unclear how to treat bacteremia caused by AB, the present study aims to enroll patients at multiple sites with extensively drug resistant Acinetobacter species bacteremia receiving different combination therapy to assess treatment outcomes and analyze risk factors associated with mortality.

Condition or disease
Acinetobacter Bacteraemia

Detailed Description:
Patients with AB bacteremia receiving antimicrobial therapy are eligible for this multicenter study. Antimicrobial agents are decided at the discretion of the attending clinical team. Clinical data to be collected include patient demographics (age, gender, underlying diseases, Pitt Bacteremia Score [20], duration of ICU stay and hospitalization before the day of first positive blood culture, central venous catheterization), antimicrobial agents on the day of bacteremia, regimens and durations of combination therapy after enrollment, and outcomes (sequential quantification change of blood A. baumannii polymerase chain reaction [PCR], survival at day 30 after enrollment, and adverse drug reactions of antimicrobial agents). Blood sample will be collected on the day of enrollment (Day 0), Day 1, 2, 3 and 7 for PCR quantification of A. baumannii and for genospecies identification. Primary end points are the interval from study enrollment to negative blood A. baumannii PCR and blood sterilization. Secondary end points are survival at 14 and 30-day after enrollment, adverse drug reactions of antimicrobial agents, and risk factors for survival at 30-day after enrollment. Inclusion criteria: 1. Adults >16 years 2. With blood culture isolate(s) A. baumannii. 3. Informed consent gained. Exclusion criteria: 1. Second/repeat episodes of bacteremia 2. Patients who could not or did not receive antimicrobial treatment 3. Patient not admitted to hospital.

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Patients With Drug Resistant Acinetobacter Baumannii Bacteremia Treated With Antibiotics Therapy
Study Start Date : August 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : June 2013
Groups and Cohorts

Group/Cohort
Colistin monotherapy
Colistin based combination therapy
Colistin-Tigecycline, Colistin-Carbapenem, Colistin-Rifampin, Colistin-HD Unasyn
Non-colistin containing regime
Glycopeptide with colistin combination
Colistin with loading dose


Outcome Measures

Primary Outcome Measures :
  1. Microbiological clearance from blood [ Time Frame: Day 0,1,2,3,7 ]
    Interval from positive to negative blood A. baumannii PCR and blood sterilization.


Secondary Outcome Measures :
  1. Survival [ Time Frame: 14, 30, in-hospital stay ]
    Survival at 14, 30-day after enrollment. Survival to discharge.

  2. Adverse drug reactions [ Time Frame: Day 0,1,2,3,7,14 ]
    Nephrotoxicity by RIFLE criteria

  3. Subsequent infections and colonization [ Time Frame: During same admission or within 1 week of discharge ]

Biospecimen Retention:   Samples With DNA
Blood sample will be collected on the day of enrollment (Day 0), Day 1, 2, 3 and 7 for PCR identification and quantification of Acinetobacter species.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted on intensive care units as well as general ward with AB bacteremia receiving antimicrobial therapy are eligible for this study.
Criteria

Inclusion Criteria:

  • Adults ( >16 years)
  • With blood culture isolate(s) A. baumannii
  • Informed consent gained

Exclusion Criteria:

  • Second/repeat episodes of bacteremia
  • Patients who could not or did not receive antimicrobial treatment
  • Patient not admitted to hospital
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511224


Contacts
Contact: Aristine Cheng, MBBChir +886 975765607 aristine@hotmail.com
Contact: Hsin-Yun Sun, MD +886 972651122 hysun13@gmail.com

Locations
Taiwan
Yunlinn NTUH Branch Recruiting
Douliou, Taiwan
Contact: Chia-Ling Yang, MD       y01944@ms1.ylh.gov.tw   
Far Eastern Memorial Hospital Recruiting
New Taipei, Taiwan, 220
Contact: Aristine Cheng, MD       aristine@hotmail.com   
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Hsin-Yun Sun, MD    +886 97265112    hysun13@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Hsin-Yun Sun, MD National Taiwan University Hospital
More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01511224     History of Changes
Other Study ID Numbers: NTUH-TD-B-111-001
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012

Keywords provided by National Taiwan University Hospital:
Bloodstream infections
Acinetobacter
Drug resistant Acinetobacter baumannii bacteremia

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Colistin
Anti-Bacterial Agents
Anti-Infective Agents