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临床试验/NCT05897034
NCT05897034尚未招募2 期

Clinical Study to Investigate the Effect of Doxycycline, Pentoxifylline, and Nitazoxanide in Sexually Active Men

Tanta University0 个研究点目标入组 100 人开始时间: 2023年6月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
入组人数
100
主要终点
treatment of chylamdia in sexually active men

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

double-blind

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

control group

Active Comparator

This group will take doxycycline 100 mg twice daily

干预措施: Doxycyclin (Drug)

Comparative group

Active Comparator

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

干预措施: Doxycyclin (Drug)

Comparative group

Active Comparator

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

干预措施: Pentoxifylline (Drug)

Comparative group

Active Comparator

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

干预措施: Nitazoxanide 500Mg Oral Tablet (Drug)

结局指标

主要结局

treatment of chylamdia in sexually active men

时间窗: 1 month

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mostafa Bahaa

Teaching assisstant

Tanta University

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