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

Study Overview
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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.

Official Title
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A Prospective Observational Study of Patients With Drug Resistant Acinetobacter Baumannii Bacteremia Treated With Antibiotics Therapy

Conditions
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Acinetobacter Bacteraemia

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colistin monotherapy<br> | |
| Colistin based combination therapy<br>Colistin-Tigecycline, Colistin-Carbapenem, Colistin-Rifampin, Colistin-HD Unasyn | |
| Non-colistin containing regime<br> | |
| Glycopeptide with colistin combination<br> | |
| Colistin with loading dose<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological clearance from blood | Interval from positive to negative blood A. baumannii PCR and blood sterilization. | Day 0,1,2,3,7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Survival at 14, 30-day after enrollment. Survival to discharge. | 14, 30, in-hospital stay | 
| Adverse drug reactions | Nephrotoxicity by RIFLE criteria | Day 0,1,2,3,7,14 | 
| Subsequent infections and colonization |  | During same admission or within 1 week of discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bloodstream infections, Acinetobacter, Drug resistant Acinetobacter baumannii bacteremia