A Prospective Observational Study of Patients With Drug Resistant Acinetobacter Baumannii Bacteremia

NCT ID: NCT01511224

Last Updated: 2012-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acinetobacter Bacteraemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Colistin monotherapy

No interventions assigned to this group

Colistin based combination therapy

Colistin-Tigecycline, Colistin-Carbapenem, Colistin-Rifampin, Colistin-HD Unasyn

No interventions assigned to this group

Non-colistin containing regime

No interventions assigned to this group

Glycopeptide with colistin combination

No interventions assigned to this group

Colistin with loading dose

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Far Eastern Memorial Hospital

OTHER

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hsin-Yun Sun, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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Yunlinn NTUH Branch

Douliu, , Taiwan

Site Status RECRUITING

Far Eastern Memorial Hospital

New Taipei City, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Aristine Cheng, MBBChir

Role: CONTACT

+886 975765607

Hsin-Yun Sun, MD

Role: CONTACT

+886 972651122

Facility Contacts

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Chia-Ling Yang, MD

Role: primary

Aristine Cheng, MD

Role: primary

Hsin-Yun Sun, MD

Role: primary

+886 97265112

Other Identifiers

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NTUH-TD-B-111-001

Identifier Type: -

Identifier Source: org_study_id

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