NCT04291768 Shortened Antibiotic Treatment of 5 Days in Gram-negative Bacteremia
| NCT ID | NCT04291768 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Thomas Benfield |
| Condition | Gram-negative Bacteremia |
| Study Type | INTERVENTIONAL |
| Enrollment | 380 participants |
| Start Date | 2020-03-11 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 380 participants in total. It began in 2020-03-11 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
GNB5 is an investigator-initiated multicentre non-inferiority randomized controlled trial which aims to assess the efficacy and safety of shortened antibiotic for patients hospitalized with a Gram negative bacteremia with a urinary tract source of infection (GNB). Five days after initiation of antimicrobial therapy for GNB, participants are randomized 1:1 to parallel treatment arms: 5 days (intervention) or minimum 7 days (control) of antibiotic treatment. The intervention group discontinues antibiotics at day 5 if clinically stable and afebrile. The control group receives antibiotics for a duration of 7 days or longer at the discretion of the treating physician. The primary outcome is 90-day survival without clinical or microbiological failure to treatment, which will be tested with a non inferiority margin of 10%.
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
Contact & Investigator
Sandra Tingsgård, MD
PRINCIPAL INVESTIGATOR
Hvidovre University Hospital
Frequently Asked Questions
Who can join the NCT04291768 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gram-negative Bacteremia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04291768 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04291768 currently recruiting?
Yes, NCT04291768 is actively recruiting participants. Contact the research team at sandra.tingsgaard@regionh.dk for enrollment information.
Where is the NCT04291768 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus, Denmark, Copenhagen, Denmark, Copenhagen, Denmark and 9 additional locations.
Who is sponsoring the NCT04291768 clinical trial?
NCT04291768 is sponsored by Thomas Benfield. The principal investigator is Sandra Tingsgård, MD at Hvidovre University Hospital. The trial plans to enroll 380 participants.