Comparison of Efficacy of Two Combination Regimens for the Neisseria Gonorrhoeae and Chlamydia Coinfection
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| ClinicalTrials.gov Identifier: NCT05216744 |
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Recruitment Status :
Completed
First Posted : January 31, 2022
Last Update Posted : March 17, 2022
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Sponsor:
Haiphong University of Medicine and Pharmacy
Information provided by (Responsible Party):
Haiphong University of Medicine and Pharmacy
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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 |
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.
| 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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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
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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 |
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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
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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 :
- cure rate [ Time Frame: 5th day after treatment ]a negative test of cure for Chlamydia trachomatis and Neisseria gonorrhoeae
Secondary Outcome Measures :
- 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
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| 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
| Vietnam | |
| Haiphong International Hospital | |
| Hải Phòng, Vietnam, 18000 | |
Sponsors and Collaborators
Haiphong University of Medicine and Pharmacy
Investigators
| Study Director: | Phuong Nguyen, PhD | Hai Phong University of Medicine and Pharmacy |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| 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:
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Neisseria Gonorrhoeae Chlamydia Trachomatis reinfection |
Additional relevant MeSH terms:
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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 |