Clinical trials

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Condition / disease
Location
Status: Recruiting

Shortened Antibiotic Treatment of 5 Days in Gram-negative Bacteremia

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%.

Participants needed: 380
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Thomas BenfieldUpdated: Feb 8, 2023Locations: 13
Eligibility criteria

Age >18 years [+6]

Antibiotic treatment (>2 day) with antimicrobial activity to Gram-negative bacte... [+6]

Status: Recruiting

Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV

MENPI is an investigator-initiated single-centre randomized controlled trial which aims to assess the efficacy and safety of meningococcal and pneumococcal vaccination in adults living with HIV receiving antiretroviral treatment. Participants are randomized 1:1 to either a two-dose Menveo® and Bexsero® regimen or a Prevenar13®/Pneumovax23® prime-boost regimen at day 0 and day 60 and cross over on day 90. All participants will follow an identical follow up program including plasma collection, pharyngeal swab, and adverse event registration. Immunogenicity will be determined on venous blood sampled at 30 days post-vaccination and yearly for five years.

Participants needed: 55
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Thomas BenfieldUpdated: May 6, 2021Locations: 1
Eligibility criteria

Age ≥ 18 years [+4]

Pregnancy or breastfeeding [+11]