New AntiBiotic Treatment Options for Uncomplicated Anogenital GOnorrhoea
Status:
Completed
Trial end date:
2020-06-05
Target enrollment:
Participant gender:
Summary
This study evaluates the efficacy of three experimental antibiotics in the treatment of
uncomplicated anogenital gonorrhoea. Participants will be randomized to one of four study
arms and will receive either one of the three experimental antibiotics (ertapenem, fosfomycin
and gentamicin) or the current standard antibiotic (ceftriaxone). Both the study team and the
participant are blinded to the administered treatment. This enables the investigators to
compare the eradication capacity and safety of the experimental antibiotics with the standard
treatment.
*Following the advise of the DSMB based on a planned interim analysis, in October 2018 one
study arm (fosfomycin 6g PO) was dropped and the randomized clinical trial was continued with
three treatment arms (ceftriaxone 500mg IM, ertapenem 1000mg IM and gentamicin 5mg/kg IM) and
without the oral placebo.
Phase:
Phase 3
Details
Lead Sponsor:
Public Health Service of Amsterdam
Collaborator:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)