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

Sponsor

Haiphong University of Medicine and Pharmacy (Other)

Overall Status

Completed

CT.gov ID

NCT05216744

Collaborator

(none)

125

Enrollment

Location

Arms

7.2

Actual Duration (Months)

17.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neisseria Gonorrhoeae Infection Chlamydia Trachomatis Infection	Drug: Ceftriaxone 1000mg + doxycycline 100 mg Drug: Cefixime 800mg + doxycycline 100 mg	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

125 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Each subject will receive one of two combination regimens including regimen A (Doxycycline plus Cefixime) or regimen B (Doxycycline plus Ceftriaxone).Each subject will receive one of two combination regimens including regimen A (Doxycycline plus Cefixime) or regimen B (Doxycycline plus Ceftriaxone).

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 15, 2021

Actual Primary Completion Date :

Feb 15, 2022

Actual Study Completion Date :

Feb 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Doxycycline plus ceftriaxone Each subject will receive 100 mg doxycycline twice daily for seven days and a single dose of ceftriaxone 1000 mg intravenously	Drug: Ceftriaxone 1000mg + doxycycline 100 mg Study comparing the effectiveness of two combination regimens in the treatment of gonorrhea and chlamydia, including regimen A (100mg doxycycline orally twice a day for 7 days + 1 dose of 1000mg ceftriaxone intravenously) and regimen B (100mg doxycycline). orally for 7 days + 1 oral dose of 800mg cefixime) Other Names: Ceftriaxone 1000mg IV plus doxycycline 100 mg PO twice daily in 7 days
Active Comparator: Doxycycline plus cefixime Each subject will receive 100 mg doxycycline twice daily for seven days and a single oral dose of cefixime 800 mg	Drug: Cefixime 800mg + doxycycline 100 mg Study comparing the effectiveness of two combination regimens in the treatment of gonorrhea and chlamydia, including regimen A (100mg doxycycline orally twice a day for 7 days + 1 dose of 1000mg ceftriaxone intravenously) and regimen B (100mg doxycycline). orally for 7 days + 1 oral dose of 800mg cefixime) Other Names: a single oral dose of Cefixime 800mg plus doxycycline 100 mg PO twice daily in 7 days

Arm

Intervention/Treatment

Experimental: Doxycycline plus ceftriaxone

Each subject will receive 100 mg doxycycline twice daily for seven days and a single dose of ceftriaxone 1000 mg intravenously

Drug: Ceftriaxone 1000mg + doxycycline 100 mg

Study comparing the effectiveness of two combination regimens in the treatment of gonorrhea and chlamydia, including regimen A (100mg doxycycline orally twice a day for 7 days + 1 dose of 1000mg ceftriaxone intravenously) and regimen B (100mg doxycycline). orally for 7 days + 1 oral dose of 800mg cefixime)

Other Names:

Ceftriaxone 1000mg IV plus doxycycline 100 mg PO twice daily in 7 days

Active Comparator: Doxycycline plus cefixime

Each subject will receive 100 mg doxycycline twice daily for seven days and a single oral dose of cefixime 800 mg

Drug: Cefixime 800mg + doxycycline 100 mg

Other Names:

a single oral dose of Cefixime 800mg plus doxycycline 100 mg PO twice daily in 7 days