Clinical trial

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

Name
3568
Description
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.
Trial arms
Trial start
2023-06-20
Estimated PCD
2024-06-20
Trial end
2028-06-20
Status
Not yet recruiting
Phase
Early phase I
Treatment
Doxycyclin
Doxycycline is a moderate-spectrum, second-generation tetracycline that is generally well tolerated
Arms:
Comparative group, control group
Pentoxifylline
Pentoxifylline is a vasoactive agent that improves the flow of blood by reducing its viscosity
Arms:
Comparative group
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
Arms:
Comparative group
Size
100
Primary endpoint
treatment of chylamdia in sexually active men
1 month
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'double-blind', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-06-12

1 organization

3 products

1 indication

Organization
Tanta University
Product
Doxycyclin