Clinical trial NCT05216744: Comparison of Efficacy of Two Combination Regimens for the Neisseria Gonorrhoeae and Chlamydia Coinfection
Official title: Comparison of Efficacy of Two Combination Regimens for the Treatment of Uncomplicated Neisseria Gonorrhoeae and Chlamydia Trachomatis Coinfection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neisseria Gonorrhoeae Infection
Chlamydia Trachomatis Infection
Keywords: Neisseria Gonorrhoeae
Chlamydia Trachomatis
reinfection
Lead sponsor: Haiphong University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each subject will receive one of two combination regimens including regimen A (Doxycycline plus Cefixime) or regimen B (Doxycycline plus Ceftriaxone).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: cure rate
timeFrame: 5th day after treatment
Secondary outcomes:
measure: Side effects
timeFrame: From 1st day of study to 5th day after treatment
Other outcomes:
Locations:
city: Hải Phòng
country: Vietnam
facility: Haiphong International Hospital
Study officials:
affiliation: Hai Phong University of Medicine and Pharmacy
name: Phuong Nguyen, PhD
role: STUDY_DIRECTOR
References:
citation: Nguyen PTT, Pham HV, Van DH, Pham LV, Nguyen HT, Nguyen HV. Randomized controlled trial of the relative efficacy of high-dose intravenous ceftriaxone and oral cefixime combined with doxycycline for the treatment of Chlamydia trachomatis and Neisseria gonorrhoeae co-infection. BMC Infect Dis. 2022 Jul 9;22(1):607. doi: 10.1186/s12879-022-07595-w.