Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT03294395
Eligibility Criteria:
Inclusion criteria main study
* 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
* 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
Exclusion criteria main study
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:
* 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:
1. Negative NAAT in spite of positive gram stain.
2. 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.
Exclusion from per protocol analysis (PP):
* Exclusion of mITT
* 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
Inclusion criteria PK substudy (healthy volunteers):
* 18 years or older
* Provide informed consent
Exclusion criteria PK substudy (healthy volunteers)
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03294395
Study Brief:
Protocol Section:
NCT03294395