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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
Haiphong University of Medicine and Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neisseria Gonorrhoeae Infection focused on measuring Neisseria Gonorrhoeae, Chlamydia Trachomatis, reinfection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 17, 2022
Last Updated
March 2, 2022
Sponsor
Haiphong University of Medicine and Pharmacy
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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

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

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