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New AntiBiotic Treatment Options for Uncomplicated Anogenital GOnorrhoea

NCT03294395 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 346

Last updated 2021-08-06

No results posted yet for this study

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.

Conditions

  • Gonorrhea

Interventions

DRUG

Ertapenem 1000 MG

single dose 1000mg intramuscular injection

DRUG

Fosfomycin Oral Suspension

single dose 6g oral suspension

DRUG

Gentamicin Sulfate, Injectable

single dose 5mg/kg (maximum 400mg) intramuscular injection

DRUG

Ceftriaxone

single dose 500mg intramuscular injection

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • Public Health Service of Amsterdam

    lead OTHER_GOV

Principal Investigators

  • Henry JC de Vries, PhD, MD · Public Health Service of Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-18
Primary Completion
2020-06-05
Completion
2020-06-05

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03294395 on ClinicalTrials.gov