Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
Conditions
Keywords
Neisseria Gonorrhoeae, Chlamydia Trachomatis, reinfection
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.
Interventions
DRUGCeftriaxone 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)
DRUGCefixime 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)
Sponsors
Haiphong University of Medicine and Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Each subject will receive one of two combination regimens including regimen A (Doxycycline plus Cefixime) or regimen B (Doxycycline plus Ceftriaxone).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cure rate | 5th day after treatment | a negative test of cure for Chlamydia trachomatis and Neisseria gonorrhoeae |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects | From 1st day of study to 5th day after treatment | Any side effects from interventions in two arms |
Countries
Vietnam
Outcome results
None listed