Comparison of Efficacy of Two Combination Regimens for the Neisseria Gonorrhoeae and Chlamydia Coinfection

Phase 2

Completed

• Conditions: Chlamydia Trachomatis Infection; Neisseria Gonorrhoeae Infection
• Interventions: Drug: Cefixime 800mg + doxycycline 100 mg; Drug: Ceftriaxone 1000mg + doxycycline 100 mg

• Registration Number: NCT05216744
• Lead Sponsor: Haiphong University of Medicine and Pharmacy

Brief Summary

The frequency of Chlamydia trachomatis and Neisseria gonorrhoeae coinfection can vary depending on their individual incidence and prevalence rates.Single-agent therapy with ceftriaxone is the preferred regimen for treatment of gonococcal infections. If an injectable cephalosporin is not available, cefixime is the only oral cephalosporin that can be used for gonococcal therapy. Doxycycline was recommended for presumptive treatment of chlamydia in nonpregnant individuals with gonococcal infection. The study is conducted to evaluate the effectiveness of two regimens in combination with doxycycline with cefixime or ceftriaxone.

Detailed Description

Gonococcal infections, including urethritis, cervicitis, epididymitis, and proctitis, are a significant cause of morbidity among sexually active men and women. The treatment of these sexually transmitted infections (STIs) has evolved over the years, mainly due to the emergence of antibiotic resistance. The frequency of Chlamydia trachomatis and Neisseria gonorrhoeae coinfection can vary depending on their individual incidence and prevalence rates. Ceftriaxone is highly effective against susceptible N. gonorrhoeae. Single-agent therapy with ceftriaxone is the preferred regimen for treatment of gonococcal infections. These doses of ceftriaxone are higher than previously recommended due to concerns regarding rising gonococcal minimum inhibitory concentrations (MICs) worldwide. If an injectable cephalosporin is not available, cefixime is the only oral cephalosporin that can be used for gonococcal therapy. Doxycycline (100 mg orally twice daily for seven days) was recommended for presumptive treatment of chlamydia in nonpregnant individuals with gonococcal infection. The study is conducted to evaluate the effectiveness of two regimens in combination with doxycycline with cefixime or ceftriaxone.

Study Timeline

• Study Start: 2021-07-15
• Status Verified: 2022-01
• Study First Submitted: 2022-01-17
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-01-31
• Primary Completion: 2022-02-15
• Study Completion: 2022-02-20
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• Patient over 18 ages with laboratory-documented uncomplicated Chlamydia trachomatis and Neisseria gonorrhoeae reinfection at any site

Exclusion Criteria

• Pregnancy
• Breast feeding
• Hypersensitivity to cephalosporins or penicillins
• significant renal failure or hepatic failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doxycycline plus cefixime	Cefixime 800mg + doxycycline 100 mg	Each subject will receive 100 mg doxycycline twice daily for seven days and a single oral dose of cefixime 800 mg
Doxycycline plus ceftriaxone	Ceftriaxone 1000mg + doxycycline 100 mg	Each subject will receive 100 mg doxycycline twice daily for seven days and a single dose of ceftriaxone 1000 mg intravenously

Primary Outcome Measures

Name	Time	Method
cure rate	5th day after treatment	a negative test of cure for Chlamydia trachomatis and Neisseria gonorrhoeae

Secondary Outcome Measures

Name	Time	Method
Side effects	From 1st day of study to 5th day after treatment	Any side effects from interventions in two arms

Trial Locations

Locations (1)

Haiphong International Hospital; 🇻🇳 Hải Phòng, Vietnam