Shortened Antibiotic Treatment of 5 Days in Gram-negative Bacteremia

Launched by THOMAS BENFIELD · Feb 27, 2020

Keywords

ClinConnect Summary

This clinical trial, called GNB5, is investigating whether a shorter course of antibiotics—5 days instead of the usual 7 or more—can be just as effective for patients with Gram-negative bacteremia stemming from a urinary tract infection. The goal is to see if patients who receive the shorter treatment can recover without complications, while also ensuring their safety. Participants will be hospitalized and, after starting their antibiotic treatment, they will be randomly assigned to either the 5-day treatment group or the 7-day treatment group, provided they're stable and have no fever.

To participate in this trial, individuals need to be over 18 years old and have a confirmed infection with Gram-negative bacteria in their blood, linked to a urinary tract infection. They should also be in stable condition when they are enrolled. This means they need to have normal blood pressure, a steady heartbeat, and no fever at the time of enrollment. It's important to note that certain conditions, such as recent antibiotic use or serious immune system issues, might prevent someone from joining the study. If eligible, participants can expect close monitoring by healthcare professionals throughout the trial to ensure their health and safety.

Gender

ALL

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