Comparison of Efficacy of Two Combination Regimens for the Neisseria Gonorrhoeae and Chlamydia Coinfection
Primary Purpose
Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
Status
Completed
Phase
Phase 2
Locations
Vietnam
Study Type
Interventional
Intervention
Ceftriaxone 1000mg + doxycycline 100 mg
Cefixime 800mg + doxycycline 100 mg
Sponsored by
About this trial
This is an interventional treatment trial for Neisseria Gonorrhoeae Infection focused on measuring Neisseria Gonorrhoeae, Chlamydia Trachomatis, reinfection
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
Sites / Locations
- Haiphong International Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Doxycycline plus ceftriaxone
Doxycycline plus cefixime
Arm Description
Each subject will receive 100 mg doxycycline twice daily for seven days and a single dose of ceftriaxone 1000 mg intravenously
Each subject will receive 100 mg doxycycline twice daily for seven days and a single oral dose of cefixime 800 mg
Outcomes
Primary Outcome Measures
cure rate
a negative test of cure for Chlamydia trachomatis and Neisseria gonorrhoeae
Secondary Outcome Measures
Side effects
Any side effects from interventions in two arms
Full Information
NCT ID
NCT05216744
First Posted
January 17, 2022
Last Updated
March 2, 2022
Sponsor
Haiphong University of Medicine and Pharmacy
1. Study Identification
Unique Protocol Identification Number
NCT05216744
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
February 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haiphong University of Medicine and Pharmacy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
Keywords
Neisseria Gonorrhoeae, Chlamydia Trachomatis, reinfection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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)
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Doxycycline plus ceftriaxone
Arm Type
Experimental
Arm Description
Each subject will receive 100 mg doxycycline twice daily for seven days and a single dose of ceftriaxone 1000 mg intravenously
Arm Title
Doxycycline plus cefixime
Arm Type
Active Comparator
Arm Description
Each subject will receive 100 mg doxycycline twice daily for seven days and a single oral dose of cefixime 800 mg
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone 1000mg + doxycycline 100 mg
Other Intervention Name(s)
Ceftriaxone 1000mg IV plus doxycycline 100 mg PO twice daily in 7 days
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Cefixime 800mg + doxycycline 100 mg
Other Intervention Name(s)
a single oral dose of Cefixime 800mg plus doxycycline 100 mg PO twice daily in 7 days
Intervention Description
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)
Primary Outcome Measure Information:
Title
cure rate
Description
a negative test of cure for Chlamydia trachomatis and Neisseria gonorrhoeae
Time Frame
5th day after treatment
Secondary Outcome Measure Information:
Title
Side effects
Description
Any side effects from interventions in two arms
Time Frame
From 1st day of study to 5th day after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phuong Nguyen, PhD
Organizational Affiliation
Hai Phong University of Medicine and Pharmacy
Official's Role
Study Director
Facility Information:
Facility Name
Haiphong International Hospital
City
Hải Phòng
ZIP/Postal Code
18000
Country
Vietnam
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35810277
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.
Results Reference
derived
Learn more about this trial
Comparison of Efficacy of Two Combination Regimens for the Neisseria Gonorrhoeae and Chlamydia Coinfection
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