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GonorrheaPhase 3NABOGONCT03294395

New AntiBiotic Treatment Options for Uncomplicated Anogenital GOnorrhoea

A Phase 3 study testing Ertapenem 1000 MG, Fosfomycin Oral Suspension and Gentamicin Sulfate, Injectable in people with Gonorrhea, run by Public Health Service of Amsterdam at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Gonorrhea
What is being tested?
Ertapenem 1000 MG, Fosfomycin Oral Suspension and Gentamicin Sulfate, Injectable
Could I receive a placebo?
No, everyone receives an active treatment
How many people
346 participants
Where
1 siteNetherlands
Study dates
18 Sep 2017to 5 Jun 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 years or older
  • Anorectal, cervical/vaginal or urethral Ng infection, diagnosed by the following:
  • Ng-positive Gram-stained smear (intracellular Gram-negative diplococci and leukocytes) and/or
  • Positive for Ng by nucleic acid amplification test (NAAT) (Aptima Combo 2) and/or
  • Positive for Ng by culture
  • Provide samples from the included infection site for NAAT and direct culture immediately before treatment
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  • Willing to abstain from anal, vaginal and oral sex until the test of cure (TOC)-visit, or use condoms during sex
  • Willing and able to return for a TOC-visit 7-14 days after treatment
  • Provide informed consent
  • Accept intramuscular injections
  • 18 years or older
  • Provide informed consent

Who cannot join

  • Pre-randomisation:
  • Suspicion of a complicated Ng infection based on signs and/or symptoms indicating pelvic inflammatory disease (PID), epididymitis, prostatitis or gonococcal arthritis*
  • Another (sexually transmitted) infection or a suspicion of another infection for which systemic antimicrobial therapy is indicated
  • Pregnancy, having a wish to become pregnant or breastfeeding (tested at inclusion visit)
  • Not able to read/understand Dutch or English
  • HIV infection if:
Show all 43Show fewer
  • Newly diagnosed HIV infection (upon the inclusion visit) and/or
  • CD4+ cell-count <200 cells/μL (as reported by the patient)
  • Known allergy or adverse reactions to ceftriaxone, ertapenemor gentamicin
  • Known renal impairment (based on estimated GFR using Cockroft and Gault formula using serum creatinin measured with a point-of-care (POC) test; cut off value renal impairment eGFR ≤ 50 ml/min)
  • Known liver cirrhosis (based on history)
  • Known congestive heart failure (based on history)
  • Known myasthenia gravis
  • Known hearing loss or balance disorder, confirmed by an ear-nose-throat (ENT)-doctor or for which an ENT doctor has been consulted and a diagnostic process is still in progress (based on history)
  • Concurrent use of any of the following medication:
  • systemic antibacterial antimicrobials other than nitrofurantoin or metronidazole
  • systemic immunosuppressive drugs
  • systemic valproic acid
  • Use of any antimicrobial therapy other than nitrofurantoin or metronidazole in the two weeks prior to study enrollment (based on history)
  • Previous enrollment in the study
  • Concurrent participation in other non-observational medical research*
  • Unlikely to adhere to the study protocol
  • Post-randomisation:
  • Exclusion of participants from the modified intention to treat analysis (mITT):
  • Negative result of Ng NAAT of sample collected on T0 (the day of treatment). This could be the case in the following situations:
  • Negative NAAT in spite of positive gram stain.
  • Positive NAAT on pre-study visit but spontaneous clearance of the infection in the time period between first test and return visit for treatment (=study inclusion visit). A novel sample for NAAT will be collected on the study inclusion visit just before administration of treatment; if these results are Ng-negative a participant will be excluded of mITT.
  • Loss to follow-up, i.e. no study visit TOC 7-14 days after treatment administration.
  • Use of non-study related antibiotics after inclusion and prior to TOC visit
  • Condomless sexual contact with the primary anatomical gonorrhea site involved after inclusion and prior to TOC visit
  • Other protocol violations
  • Pre-randomisation:
  • Pregnancy, having a wish to become pregnant or breastfeeding (tested at inclusion visit)
  • Not able to read/understand Dutch or English
  • Known allergy or adverse reactions to ceftriaxone, ertapenem, or fosfomycin.
  • Known renal impairment (based on estimated GFR using Cockroft and Gault formula using serum creatinin measured with a point-of-care (POC) test; cut off value renal impairment eGFR ≤ 50 ml/min)
  • Known liver cirrhosis (based on history)
  • Concurrent use of any of the following medication:
  • systemic valproic acid
  • systemic metoclopramide
  • Use of any systemic antimicrobial therapy other than nitrofurantoin or metronidazole in the two weeks prior to study enrollment (based on history)
  • Concurrent participation in other non-observational medical research (apart from NABOGO RCT)
  • Unlikely to adhere to the study

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Public Health Service

    Amsterdam, North Holland, 1018WT

Other trials in Netherlands

About this study

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

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.

Read the 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
Being tested
Ertapenem 1000 MG, Fosfomycin Oral Suspension, Gentamicin Sulfate, Injectable, Ceftriaxone
Keywords
Antimicrobial resistance, Antibiotics, Fosfomycin, Ertapenem, Gentamicin, Neisseria Gonorrhoeae
Medical subject headings
Gonorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ertapenem 1000 MGDrug

    Also called Invanz

    single dose 1000mg intramuscular injection

  • Fosfomycin Oral SuspensionDrug

    Also called Monuril

    single dose 6g oral suspension

  • Gentamicin Sulfate, InjectableDrug

    Also called no other names

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

  • CeftriaxoneDrug

    Also called no other names

    single dose 500mg intramuscular injection

Study groups in NCT03294395
Study groupRoleWhat they receive
Ceftriaxone imActive comparatorCurrent standard treatment. Ceftriaxone 500mg (single intramuscular dose) + placebo (single oral dose)
Receives: Drug: Ceftriaxone
Ertapenem imExperimentalErtapenem 1000mg (single intramuscular dose) + placebo (single oral dose)
Receives: Drug: Ertapenem 1000 MG
Fosfomycin poExperimentalFosfomycin oral suspension 6g (single oral dose) + placebo (single intramuscular dose)
Receives: Drug: Fosfomycin Oral Suspension
Gentamicin imExperimentalGentamicin sulfate, injectable 5mg/kg (single intramuscular dose) + placebo (single oral dose)
Receives: Drug: Gentamicin Sulfate, Injectable

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with treatment success in each study arm for the included anatomic infection

    Proportion of participants with treatment success in each study arm using a molecular test (Nucleic acid amplification test, NAAT). Treatment succes is defined as a negative test of cure (NAAT) 7-14 days after treatment.

    Measured: 7-14 days after treatment

Secondary outcomes (7)

  1. Proportion of participants with treatment success in each study arm at all anatomical infection sites

    Proportion of participants with treatment success in each study arm using a molecular test (Nucleic acid amplification test, NAAT). Treatment succes is defined as a negative test of cure (NAAT) 7-28 days after treatment.

    Measured: 7-28 days after treatment

  2. Incidence of treatment-emergent adverse events

    The incidence, type and severity of treatment-related adverse events as assessed by CTCAE v4.0 will be measured.

    Measured: until 30 days after treatment

  3. Antimicrobial susceptibility of Ng-strains to study antibiotics

    The in vitro antimicrobial susceptibility (in MIC) of the experimental and reference treatment will be measured in all Ng strains collected at all infected anatomical sites of each participant at inclusion and in case of a positive test of cure.

    Measured: Day 0 (before treatment) - 28 (after treatment)

  4. Blood plasma concentration of ceftriaxone, ertapenem and gentamicin in a subset of 60 NABOGO participants

    The blood plasma concentration will be measured 1 times within the first 24 hours after treatment administration. With these measurements the investigators will estimate the population pharmacokinetics of ceftriaxone, ertapenem and gentamicin.

    Measured: within 24 hours after treatment administration

  5. Duration of symptoms after treatment

    All participants are asked to report their symptoms daily in a diary, this will be evaluated at the follow-up visit (7-14 days after treatment) and at the online evaluation questionnaire (30 days after treatment). The mean duration of all symptoms after treatment will be measured for all study antibiotics.

    Measured: 1-30 days after treatment

  6. Clinical and demographic predictors for treatment failure

    The investigators will measure if demographic (e.g. gender, HIV status) and clinical factors (e.g. anatomical location, duration of symptoms before treatment) are associated with treatment failure (treatment failure is defined as any case in which the participant received escape medication).

    Measured: until 7-14 days after treatment

  7. Blood plasma concentration of ceftriaxone, ertapenem and fosfomycin in 60 healthy volunteers

    Healthy volunteers will be randomly assigned to one of the three antibiotics. After administration of the antibiotic, the blood plasma concentration will be measured 4 times within the first 24 hours. With these measurements the investigators will estimate the population pharmacokinetics of ceftriaxone, ertapenem and fosfomycin.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2017
  2. Study start18 Sep 2017
  3. Primary completion5 Jun 2020
  4. Study completion5 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A double-blind randomized clinical trial with non-inferiority design \*since October 2018 one study arm (fosfomycin) has been dropped. In a subset of these participants the plasma concentration of ceftriaxone, ertapenem and gentamicin is measured. An open-label randomized substudy evaluating the pharmacokinetics of ceftriaxone ertapenem and fosfomycin in 60 healthy volunteers (this number is in addition to the 346 NABOGO participants with gonorrhea)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
346 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03294395
Sponsor's protocol ID
NABOGO
Acronym
NABOGO
Status last verified
Jul 2021
First submitted
18 Sep 2017
Last updated
6 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Teker B, Schim van der Loeff M, Boyd A, Mathot R, van Dam A, de Vries H, Jongen VW. Diarrhoea as a frequent adverse event after intramuscular ertapenem treatment for uncomplicated Neisseria gonorrhoeae: a secondary analysis from the NABOGO trial. Sex Transm Infect. 2026 Jan 16:sextrans-2025-056735. doi: 10.1136/sextrans-2025-056735. Online ahead of print.

    PubMed 41545057

  • Teker B, de Vries H, Heijman T, van Dam A, Schim van der Loeff M, Jongen VW. Spontaneous clearance of asymptomatic anogenital and pharyngeal Neisseria gonorrhoeae: a secondary analysis from the NABOGO trial. Sex Transm Infect. 2023 Jun;99(4):219-225. doi: 10.1136/sextrans-2022-055488. Epub 2022 Jul 12.

    PubMed 35820778

  • de Vries HJC, de Laat M, Jongen VW, Heijman T, Wind CM, Boyd A, de Korne-Elenbaas J, van Dam AP, Schim van der Loeff MF; NABOGO steering group. Efficacy of ertapenem, gentamicin, fosfomycin, and ceftriaxone for the treatment of anogenital gonorrhoea (NABOGO): a randomised, non-inferiority trial. Lancet Infect Dis. 2022 May;22(5):706-717. doi: 10.1016/S1473-3099(21)00625-3. Epub 2022 Jan 19.

    PubMed 35065063

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ertapenem 1000 MG, Fosfomycin Oral Suspension and Gentamicin Sulfate, Injectable in people with Gonorrhea, run by Public Health Service of Amsterdam at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with treatment success in each study arm for the included anatomic infection (time frame: 7-14 days after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03294395, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.

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