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

NCT06090565 | Completed Phase 4

• 1 other identifier: 9937
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Neisseria gonorrhoeae; Cefixime; Azithromycin; Ceftriaxone; Doxycycline

Outcome Measures

Primary Outcomes (1)

• Number of Participants with negative cultures 1 and 3 weeks and a negative NAAT 3 weeks (±3 days) after treatment initiation.

  To assess the eradication rate of Neisseria gonorrhoeae by culture and NAAT following a single-dose cefixime 800 mg plus doxycycline 100 mg b.i.d. for 7 days compared to single-dose ceftriaxone 1 g plus single-dose azithromycin 2 g (Intent to Treat population).

  One and three weeks (±3 days)

Secondary Outcomes (2)

• Number of Participants with clinical cure defined as disappearance of clinical symptoms and signs 1 week after treatment according to the clinical assessment of the patient by the physician.

  One week (±3 days)

• Occurrence of treatment-related severe adverse events in treatment groups

  One and three weeks (±3 days)

Study Arms (2)

Cefixime plus doxycycline

EXPERIMENTAL

Single-dose cefixime 800 mg plus doxycycline 100 mg b.i.d. for 7 days

Drug: Cefixime; Drug: Doxycyclin

Ceftriaxone plus azithromycin

ACTIVE COMPARATOR

Single dose ceftriaxone 1 g plus single-dose azithromycin 2 g

Drug: Ceftriaxon; Drug: Azithromycin

Interventions

Cefixime DRUG

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

Also known as: Cefixime (ATC code J01DD08)

Cefixime plus doxycycline

Doxycyclin DRUG

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

Also known as: Doxyhexal (ATC code J01AA02)

Cefixime plus doxycycline

Ceftriaxon DRUG

Dose of 1 g intramuscular one time

Also known as: Ceftriaxone (ATC code J01DD04)

Ceftriaxone plus azithromycin

Azithromycin DRUG

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

Also known as: Sumamed (ATC code J01FA10)

Ceftriaxone plus azithromycin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• uncomplicated urogenital, rectal or pharyngeal gonorrhoea diagnosed using the nucleic acid amplification test

You may not qualify if:

• any antimicrobial treatment during the 4 weeks before study enrolment
• pregnancy or lactation
• autoimmune disease
• renal, hepatic or cardiac insufficiency
• immunosuppressive therapy
• allergy to cephalosporins, macrolides or doxycycline

Sponsors & Collaborators

• Bulovka Hospital: lead
• Örebro University, Sweden: collaborator

Study Sites (2)

Venereology Prague, Medicentrum Beroun

Prague, 15000, Czechia

Location

University Hospital Bulovka

Prague, 18081, Czechia

Location

MeSH Terms

Conditions

Gonorrhea

Interventions

Cefixime; Doxycycline; Ceftriaxone; Azithromycin

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Filip Rob, MD, PhD

  Nemocnice Na Bulovce

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Dermatovenereology Dept.

Model Details: Patients were randomised to cefixime 800 mg single oral dose plus doxycycline 100 mg twice a day orally for 7 days or the comparator ceftriaxone 1 g single intramuscular dose plus azithromycin 2 g single oral dose with a computer-generated pseudo-random code using permuted block randomisation in a 1:1 ratio

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: April 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 22, 2022
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)