NCT03294395

New AntiBiotic Treatment Options for Uncomplicated Anogenital GOnorrhoea

New Antibiotic Treatment Options for Uncomplicated Anogenital Gonorrhoea Infections - a Double-blind Randomized Controlled Non-inferiority Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 346 (actual)
• Sponsor: Public Health Service of Amsterdam · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Antimicrobial resistance (AMR) to extended spectrum cephalosporins (ESC) among Neisseria gonorrhoeae (Ng) is a major public health concern. With no alternative antimicrobial treatment options for gonorrhoea and only a few new drugs in the development pipeline, it is important to test existing antibiotics for their efficacy in gonorrhoea treatment. This project aims to identify new treatment modalities for uncomplicated gonorrhoea using the registered drugs ertapenem, fosfomycin and gentamicin. This trial is a double blind randomized clinical non-inferiority trial with four treatment arms. 108 participants are randomly assigned to each study arm . Participants will receive either ceftriaxone 500mg intramuscularly (IM) or ertapenem 1000mg IM or gentamicin 5mg/kg IM with a maximum of 400mg (in two doses) supplemented with an oral placebo, or receive fosfomycin 6g oral suspension supplemented with an intramuscular placebo. The bacterial eradication capacity of the study antimicrobials at the included infection site is measured 7-14 days after treatment, using an RNA-based Nucleic Acid Amplification Test (NAAT). \*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

Type	Name	Description
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

Timeline

• Start date: 2017-09-18
• Primary completion: 2020-06-05
• Completion: 2020-06-05
• First posted: 2017-09-27
• Last updated: 2021-08-06

Locations

1 site across 1 country: Netherlands