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Clinical Trials/EUCTR2021-003616-10-BE
EUCTR2021-003616-10-BE
Active, not recruiting
Phase 1

An open label randomized controlled trial comparing the effect of ceftriaxone plus azithromycin versus ceftriaxone for the treatment of Neisseria gonorrhoeae on the resistome - ResistAZM Trial

Institute of Tropical Medicine0 sites42 target enrollmentOctober 15, 2021
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Conditionseisseria gonorrhoeae (Ng)MedDRA version: 21.1Level: LLTClassification code 10051970Term: Neisseria gonorrhoeae infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
DrugsAzithromycinCeftriaxone

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
eisseria gonorrhoeae (Ng)
Sponsor
Institute of Tropical Medicine
Enrollment
42
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 15, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
Institute of Tropical Medicine

Eligibility Criteria

Inclusion Criteria

  • •1\.Able and willing to provide written informed consent
  • •2\.Male sex at birth
  • •3\.At least 18 years old
  • •4\.Confirmed diagnosis of urethritis, proctitis or pharyngitis Ng – symptomatic or asymptomatic (Diagnosis of Ng will be by a positive NAAT performed according to the ITMs current laboratory protocols or for patients with urethritis a positive gram/methylene blue stain)
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 38
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 4

Exclusion Criteria

  • •1\.Use of any macrolide antibiotics (azithromycin, clarithromycin, erythromycin, roxithromycin, spiramycin) in previous 6 months
  • •2\.Known contra\-indications or allergy to ceftriaxone, azithromycin or lidocaine
  • •3\.Presence of any other condition, including other STIs that will (likely) require the administration of another antibiotic at the time of enrollment, as assessed by the treating physician

Outcomes

Primary Outcomes

Not specified

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