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

NCT05216744 | Completed Phase 2

• 1 other identifier: HPMU.19.10.21
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Neisseria Gonorrhoeae Infection; Chlamydia Trachomatis Infection

Keywords

Neisseria Gonorrhoeae; Chlamydia Trachomatis; reinfection

Outcome Measures

Primary Outcomes (1)

• cure rate

  a negative test of cure for Chlamydia trachomatis and Neisseria gonorrhoeae

  5th day after treatment

Secondary Outcomes (1)

• Side effects

  From 1st day of study to 5th day after treatment

Study Arms (2)

Doxycycline plus ceftriaxone

EXPERIMENTAL

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

Doxycycline plus cefixime

ACTIVE COMPARATOR

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

Interventions

Ceftriaxone 1000mg + doxycycline 100 mg DRUG

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)

Also known as: Ceftriaxone 1000mg IV plus doxycycline 100 mg PO twice daily in 7 days

Doxycycline plus ceftriaxone

Cefixime 800mg + doxycycline 100 mg DRUG

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)

Also known as: a single oral dose of Cefixime 800mg plus doxycycline 100 mg PO twice daily in 7 days

Doxycycline plus cefixime

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 18 ages with laboratory-documented uncomplicated Chlamydia trachomatis and Neisseria gonorrhoeae reinfection at any site

You may not qualify if:

• Pregnancy
• Breast feeding
• Hypersensitivity to cephalosporins or penicillins
• significant renal failure or hepatic failure

Sponsors & Collaborators

• Haiphong University of Medicine and Pharmacy: lead

Study Sites (1)

Haiphong International Hospital

Haiphong, 18000, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 35810277 DERIVED

MeSH Terms

Conditions

Gonorrhea; Reinfection

Interventions

Ceftriaxone; Doxycycline; Cefixime

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Recurrence; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Phuong Nguyen, PhD

  Hai Phong University of Medicine and Pharmacy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each subject will receive one of two combination regimens including regimen A (Doxycycline plus Cefixime) or regimen B (Doxycycline plus Ceftriaxone).

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 31, 2022
• Study Start: July 15, 2021
• Primary Completion: February 15, 2022
• Study Completion: February 20, 2022
• Last Updated: March 17, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)