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

• ClinicalTrials.gov Identifier: NCT05897034
• Recruitment Status: Not yet recruiting
• First Posted: June 9, 2023
• Last Update Posted: June 12, 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
• Information provided by (Responsible Party): Mostafa Bahaa, Tanta University

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.

Condition or disease	Intervention/treatment	Phase
Sexually Transmitted Diseases	Drug: Doxycyclin; Drug: Pentoxifylline; Drug: Nitazoxanide 500Mg Oral Tablet	Phase 2; Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Masking Description: double-blind
• Primary Purpose: Treatment
• Official Title: Clinical Study to Investigate the Effect of Doxycycline, Pentoxifylline, and Nitazoxanide in Sexually Active Men
• Estimated Study Start Date: June 20, 2023
• Estimated Primary Completion Date: June 20, 2024
• Estimated Study Completion Date: June 20, 2028

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: control group; This group will take doxycycline 100 mg twice daily	Drug: Doxycyclin; Doxycycline is a moderate-spectrum, second-generation tetracycline that is generally well tolerated
Active Comparator: Comparative group; This group will take doxycycline 100 mg twice daily, pentoxifylline 400 mg twice daily, and nitazoxanide 500 mg twice daily.	Drug: Doxycyclin; Doxycycline is a moderate-spectrum, second-generation tetracycline that is generally well tolerated; Drug: Pentoxifylline; Pentoxifylline is a vasoactive agent that improves the flow of blood by reducing its viscosity; Drug: Nitazoxanide 500Mg Oral Tablet; 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

Outcome Measures

Primary Outcome Measures :

1. treatment of chylamdia in sexually active men [ Time Frame: 1 month ]
   treatment of chylamdia in sexually active men and decreasing resistance to antibiotics

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Mostafa Bahaa, Teaching assisstant, Tanta University
• ClinicalTrials.gov Identifier: NCT05897034
• Other Study ID Numbers: 3568
• First Posted: June 9, 2023
• Last Update Posted: June 12, 2023
• Last Verified: June 2023

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

Additional relevant MeSH terms:

Sexually Transmitted Diseases; Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Doxycycline; Nitazoxanide; Pentoxifylline; Anti-Bacterial Agents; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Vasodilator Agents; Free Radical Scavengers; Antioxidants