Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05216744
Recruitment Status : Completed
First Posted : January 31, 2022
Last Update Posted : March 17, 2022
Sponsor:
Information provided by (Responsible Party):
Haiphong University of Medicine and Pharmacy

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.

Condition or disease Intervention/treatment Phase
Neisseria Gonorrhoeae Infection Chlamydia Trachomatis Infection Drug: Ceftriaxone 1000mg + doxycycline 100 mg Drug: Cefixime 800mg + doxycycline 100 mg Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy of Two Combination Regimens for the Treatment of Uncomplicated Neisseria Gonorrhoeae and Chlamydia Trachomatis Coinfection
Actual Study Start Date : July 15, 2021
Actual Primary Completion Date : February 15, 2022
Actual Study Completion Date : February 20, 2022


Arm Intervention/treatment
Experimental: Doxycycline plus ceftriaxone
Each subject will receive 100 mg doxycycline twice daily for seven days and a single dose of ceftriaxone 1000 mg intravenously
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)
Other Name: Ceftriaxone 1000mg IV plus doxycycline 100 mg PO twice daily in 7 days

Active Comparator: Doxycycline plus cefixime
Each subject will receive 100 mg doxycycline twice daily for seven days and a single oral dose of cefixime 800 mg
Drug: 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)
Other Name: a single oral dose of Cefixime 800mg plus doxycycline 100 mg PO twice daily in 7 days




Primary Outcome Measures :
  1. cure rate [ Time Frame: 5th day after treatment ]
    a negative test of cure for Chlamydia trachomatis and Neisseria gonorrhoeae


Secondary Outcome Measures :
  1. Side effects [ Time Frame: From 1st day of study to 5th day after treatment ]
    Any side effects from interventions in two arms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05216744


Locations
Layout table for location information
Vietnam
Haiphong International Hospital
Hải Phòng, Vietnam, 18000
Sponsors and Collaborators
Haiphong University of Medicine and Pharmacy
Investigators
Layout table for investigator information
Study Director: Phuong Nguyen, PhD Hai Phong University of Medicine and Pharmacy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Haiphong University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT05216744    
Other Study ID Numbers: HPMU.19.10.21
First Posted: January 31, 2022    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haiphong University of Medicine and Pharmacy:
Neisseria Gonorrhoeae
Chlamydia Trachomatis
reinfection
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Communicable Diseases
Chlamydia Infections
Gonorrhea
Coinfection
Disease Attributes
Pathologic Processes
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Neisseriaceae Infections
Doxycycline
Ceftriaxone
Cefixime
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents