Bacteremia Clinical Trial
— THREATOfficial title:
Turkish Prospective Cohort Study on Carbapenem Resistant Klebsiella Pneumonia Bacteremia: a National Multicenter Observational Study
Verified date | July 2019 |
Source | Koç University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Carbapenem-resistant Klebsiella pneumonia (CRKp) blood stream infections (BSI) cause substantial mortality among hospitalized patients. Treatment options for CRKp infections are limited and increasing resistance rates to few available drugs, i.e., colistin, is a big concern. This prospective multicenter observational study is designed to describe clinical characteristics and outcomes of patients with CRKp bacteremia in an oxacillinase-48 (OXA-48) endemic country to define predictors of mortality with a focus on the impact of mono versus combination therapies on mortality. The study will also investigate risk factors associated with colistin-resistant CRKp BSI.
Status | Completed |
Enrollment | 278 |
Est. completion date | July 22, 2019 |
Est. primary completion date | June 25, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - All adult patients (=18 years old) with clinically significant CRKp bacteremia Exclusion Criteria: - Polymicrobial infection (except coagulase-negative staphylococci or other skin contaminants isolated from one blood culture bottle, which is considered contamination) - Subsequent CRKp bacteremia episodes from the same patient |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara University | Ankara | |
Turkey | Baskent University | Ankara | |
Turkey | Hacettepe University | Ankara | |
Turkey | Ministry of Health, Ankara Training and Research Hospital | Ankara | |
Turkey | Uluduag University | Bursa | |
Turkey | American Hospital | Istanbul | |
Turkey | Cerrahpasa University | Istanbul | |
Turkey | Istanbul Bilim University | Istanbul | |
Turkey | Istanbul Sultan Abdülhamid Han Training and Research Hospital | Istanbul | |
Turkey | Istanbul Training and Research Hospital | Istanbul | |
Turkey | Koç University | Istanbul | |
Turkey | Marmara University | Istanbul | |
Turkey | Ministry of Health Okmeydani Training and Research Hospital | Istanbul | |
Turkey | Ministry Of Health, Kartal Kosuyolu High Speciality Educational and Research Hospital | Istanbul | |
Turkey | Dokuz Eylül University | Izmir |
Lead Sponsor | Collaborator |
---|---|
Koç University |
Turkey,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 30-day crude mortality | Death by any cause | 1 month | |
Secondary | In-hospital mortality | Death by any cause during hospitalization | 1 month | |
Secondary | Clinical response at day 7 and 14 | Complete response: Improvement in clinical response resulting in ceasing of antibiotic therapy. Partial response: Improvement in clinical response with continuation of antibiotic therapy. No response: No improvement |
day 7 and 14 | |
Secondary | Microbiologic eradication | Established: No growth in follow-up cultures on day 3, 7 or 14 Presumed: No follow up cultures performed but clinical response is observed Unknown: No follow up cultures performed, and no clinical response observed |
day 3, 7 and/or 14 | |
Secondary | Infection related mortality | Mortality attributed to the infection by the local investigators. Attributable (directly related) Contributable (indirectly related) Non-related |
1 month | |
Secondary | Duration of hospital stay after infection | Duration of hospital stay after infection until day 30 | 1 month | |
Secondary | ICU stay after infection | Duration of ICU stay after infection until day 30 | 1 month | |
Secondary | Duration of antibiotic treatment | Total duration of antibiotic treatment | 1 month | |
Secondary | Recurrence | Recurrence of CRKp bacteremia within 30 days after clinical and/or microbiological response | 1 month | |
Secondary | Superinfection | Occurrence of any infection by a different organism during the 30-day period after the initial blood culture positive for CRKp. | 1 month | |
Secondary | Colistin resistance development | Isolation of colistin-resistant CRKp from blood cultures or other sites during the 30-day period when the initial blood culture was positive for colistin-susceptible CRKp. | 1 month | |
Secondary | Nephrotoxicity | Increase in serum creatinine to =1.5 times baseline which is known or presumed to have occurred within the prior 7 days | 1 month |
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