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Combination Therapy Between Doxycycline, Pentoxifylline, and Nitazoxanide in Sexually Active Men

Primary Purpose

Sexually Transmitted Diseases

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Doxycyclin
Pentoxifylline
Nitazoxanide 500Mg Oral Tablet
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexually Transmitted Diseases

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Individuals aged > 18 years were eligible for participation if they had a diagnosis of untreated gonorrhea and chlamydia. The untreated status was defined as no antibiotic taken in the previous 28 days to treat gonorrhea and chlamydia. Exclusion Criteria: known contraindications or hypersensitivity to doxycycline, pentoxifylline, and nitazoxanide. gonorrhea with complications, such as pelvic inflammatory disease or epididymo-orchitis significant renal failure or hepatic failure.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    control group

    Comparative group

    Arm Description

    This group will take doxycycline 100 mg twice daily

    This group will take doxycycline 100 mg twice daily, pentoxifylline 400 mg twice daily, and nitazoxanide 500 mg twice daily.

    Outcomes

    Primary Outcome Measures

    treatment of chylamdia in sexually active men
    treatment of chylamdia in sexually active men and decreasing resistance to antibiotics

    Secondary Outcome Measures

    Full Information

    First Posted
    May 31, 2023
    Last Updated
    June 8, 2023
    Sponsor
    Tanta University
    Collaborators
    Marwa Ahmed El-Samongy Dermatology and Venereology Department, Tanta University., Mostafa Mahmoud Bahaa Clinical Pharmacy Department, Horus University, New Damietta, Egypt
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05897034
    Brief Title
    Combination Therapy Between Doxycycline, Pentoxifylline, and Nitazoxanide in Sexually Active Men
    Official Title
    Clinical Study to Investigate the Effect of Doxycycline, Pentoxifylline, and Nitazoxanide in Sexually Active Men
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 20, 2023 (Anticipated)
    Primary Completion Date
    June 20, 2024 (Anticipated)
    Study Completion Date
    June 20, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tanta University
    Collaborators
    Marwa Ahmed El-Samongy Dermatology and Venereology Department, Tanta University., Mostafa Mahmoud Bahaa Clinical Pharmacy Department, Horus University, New Damietta, Egypt

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Bacterial sexually transmitted infections (STIs) have been steadily increasing in gay, bisexual, and other men who have sex with men (MSM) over the past 2 decades. While that trend started prior to the introduction of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) in 2012, HIV PrEP has been associated with increases in sexual contacts and decreases in condom use with an resultant acceleration in the increase of bacterial STIs such as gonorrhea, syphilis, and chlamydia.
    Detailed Description
    Doxycycline is a moderate-spectrum, second-generation tetracycline that is generally well tolerated. It is rapidly and almost completely absorbed after oral administration. First introduced commercially in the 1960s, doxycycline has been used by millions to manage acne and as primary prophylaxis for scrub typhus, leptospirosis, malaria, and Lyme disease. There are anecdotal reports of doxycycline used for syphilis prophylaxis among US and Australian military personnel during the Vietnam War. Doxycycline is a first-line agent for treatment of chlamydia and an alternative regimen for syphilis.An open-label extension of the French national HIV research agency (France Recherche Nord & sud Sida-hiv hépatites [ANRS]) Intervention Préventive de l'Exposition aux Risques avec et pour les Gays (IPERGAY) HIV-prevention study continued participant access to HIV PrEP and examined doxycycline postexposure prophylaxis (Doxy PEP) in MSM and transgender women without HIV [17]. Participants (n = 232) were randomly assigned 1:1 to the intervention-doxycycline 200 mg within 24-72 hours of condomless sexual encounters up to 3 times per week-or to no prophylaxis. Those taking Doxy PEP had lower STI incidence (hazard ratio, 0.57; P = .014). Chlamydia trachomatis and syphilis diagnoses were significantly lower in the intervention arm, with a relative reduction of 70-73% in the intention-to-treat analysis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sexually Transmitted Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Masking Description
    double-blind
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    This group will take doxycycline 100 mg twice daily
    Arm Title
    Comparative group
    Arm Type
    Active Comparator
    Arm Description
    This group will take doxycycline 100 mg twice daily, pentoxifylline 400 mg twice daily, and nitazoxanide 500 mg twice daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Doxycyclin
    Intervention Description
    Doxycycline is a moderate-spectrum, second-generation tetracycline that is generally well tolerated
    Intervention Type
    Drug
    Intervention Name(s)
    Pentoxifylline
    Intervention Description
    Pentoxifylline is a vasoactive agent that improves the flow of blood by reducing its viscosity
    Intervention Type
    Drug
    Intervention Name(s)
    Nitazoxanide 500Mg Oral Tablet
    Intervention Description
    Nitazoxanide is a broad-spectrum antiparasitic and broad-spectrum antiviral medication that is used in medicine for the treatment of various helminthic, protozoal, and viral infections
    Primary Outcome Measure Information:
    Title
    treatment of chylamdia in sexually active men
    Description
    treatment of chylamdia in sexually active men and decreasing resistance to antibiotics
    Time Frame
    1 month

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Individuals aged > 18 years were eligible for participation if they had a diagnosis of untreated gonorrhea and chlamydia. The untreated status was defined as no antibiotic taken in the previous 28 days to treat gonorrhea and chlamydia. Exclusion Criteria: known contraindications or hypersensitivity to doxycycline, pentoxifylline, and nitazoxanide. gonorrhea with complications, such as pelvic inflammatory disease or epididymo-orchitis significant renal failure or hepatic failure.

    12. IPD Sharing Statement

    Learn more about this trial

    Combination Therapy Between Doxycycline, Pentoxifylline, and Nitazoxanide in Sexually Active Men

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