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

NCT05897034 | Not Yet Recruiting Phase 2

• 1 other identifier: 3568
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sexually Transmitted Diseases

Outcome Measures

Primary Outcomes (1)

• treatment of chylamdia in sexually active men

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

  1 month

Study Arms (2)

control group

ACTIVE COMPARATOR

This group will take doxycycline 100 mg twice daily

Drug: Doxycyclin

Comparative group

ACTIVE COMPARATOR

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

Drug: Doxycyclin; Drug: Pentoxifylline; Drug: Nitazoxanide 500Mg Oral Tablet

Interventions

Doxycyclin DRUG

Doxycycline is a moderate-spectrum, second-generation tetracycline that is generally well tolerated

Comparative group; control group

Pentoxifylline DRUG

Pentoxifylline is a vasoactive agent that improves the flow of blood by reducing its viscosity

Comparative group

Nitazoxanide 500Mg Oral Tablet DRUG

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

Comparative group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead
• Mostafa Mahmoud Bahaa Clinical Pharmacy Department, Horus University, New Damietta, Egypt: collaborator

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Doxycycline; Pentoxifylline; nitazoxanide; Tablets

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assisstant

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 9, 2023
• Study Start: June 20, 2023
• Primary Completion: June 20, 2024
• Study Completion (Estimated): June 20, 2028
• Last Updated: June 12, 2023

Record last verified: 2023-06