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NCT05216744 Clinical Trial

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

Chlamydia Trachomatis Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05216744
Other study ID # HPMU.19.10.21
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 15, 2021
Est. completion date February 20, 2022

Study information
Verified date January 2022
Source Haiphong University of Medicine and Pharmacy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 125
Est. completion date February 20, 2022
Est. primary completion date February 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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)
• 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)

Locations
Country Name City State
Vietnam Haiphong International Hospital H?i Phòng

Sponsors (1)
Lead Sponsor Collaborator
Haiphong University of Medicine and Pharmacy

Country where clinical trial is conducted

Vietnam, 

Outcome
Type Measure Description Time frame Safety issue
Primary cure rate a negative test of cure for Chlamydia trachomatis and Neisseria gonorrhoeae 5th day after treatment
Secondary Side effects Any side effects from interventions in two arms From 1st day of study to 5th day after treatment
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