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Cefixime Plus Doxycycline Compared to Ceftriaxone Plus Azithromycin for Treatment of Gonorrhoea

NCT06090565 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2023-10-23

No results posted yet for this study

Summary

A non-inferiority, open-label, multicentre randomised controlled trial to compare two therapeutic regimens for the treatment of uncomplicated urogenital, rectal or pharyngeal gonorrhoea in men and women between 18 and 75 years of age. Patients were enrolled and treated from April 2021 to June 2022 at the Dermatovenerology Department, University Hospital Bulovka, Prague, Czech Republic and the Venereology Prague, Medicentrum Beroun, Prague, Czech Republic.

Conditions

  • Gonorrhea

Interventions

DRUG

Cefixime

Two 400 mg tablets will be administered orally to equal a 800 mg dose.

DRUG

Doxycyclin

One 100 mg tablet will be administered orally twice a day for 7 days

DRUG

Ceftriaxon

Dose of 1 g intramuscular one time

DRUG

Azithromycin

Four 500 mg tablets will be administered orally to equal a 2 g dose.

Sponsors & Collaborators

  • Örebro University, Sweden

    collaborator OTHER

  • Bulovka Hospital

    lead OTHER

Principal Investigators

  • Filip Rob, MD, PhD · Nemocnice Na Bulovce

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-06-30
Completion
2022-12-22

Countries

  • Czechia

Study Locations

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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 NCT06090565 on ClinicalTrials.gov