Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-24 @ 5:59 PM
NCT ID:
NCT04291768
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years
* Blood culture positive for Gram-negative bacteria
* Evidence of urinary tract source of infection (positive urine culture or at least one clinical symptom compatible with urinary tract infection)
* Antibiotic treatment with antimicrobial activity to Gram-negative bacteria administrated within 12 hours of first blood culture
* Temperature \<37.8°C at randomization
* Clinically stabile at randomization (systolic blood pressure \> 90 mm Hg, heart rate \<100 beats/min., respiratory rate \<24/minute, peripheral oxygen saturation \> 90 %)
* Oral and written informed consent
Exclusion Criteria:
* Antibiotic treatment (\>2 day) with antimicrobial activity to Gram-negative bacteria within 14 days of inclusion
* Gram-negative bacteremia within 30 days of blood culture
* Immunosuppression (Untreated HIV-infection, Neutropenia (absolute neutrophil count \< 1.0 x 109/l), Untreated terminal cancer, Receiving immunosuppressive agents (ATC-code L04A), Corticosteroid treatment (≥20 mg/day prednisone or the equivalent for \>14 days) within the last 30 days, Chemotherapy within the last 30 days, Immunosuppressed after solid organ transplantation, Asplenia)
* Polymicrobial growth in blood culture
* Bacteremia with non-fermenting Gram-negative bacteria (Acinetobacter spp, Burkholderia spp, Pseudomonas spp), Brucella spp, or Fusobacterium spp
* Failure to remove source of infection within 72 hours of first blood culture (e.g. change of catheter á demeure)
* Pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04291768
Study Brief:
Protocol Section:
NCT04291768