Safety and Efficacy of Two Oral Tinidazole Regimens for Refractory Trichomonas Vaginitis

Shangrong Fan

Status: Begins enrollment in 6 months

Conditions: Trichomonas Vaginitis

Treatments: Drug: Tinidazole 56; Drug: Tinidazole 42

Study type: Interventional

Funder types: Other

Identifiers

NCT05383521

2020PUSZH001

Details and patient eligibility

About

We compare two oral tinidazole regimens for refractory trichomonas vaginitis.

Full description

Refractory trichomonas vaginitis has become a clinical problem, which has a direct impact on the health and life of patients. Refractory trichomonas vaginitis is mainly caused by drug resistance of trichomonas. Drug resistant trichomonas has appeared China. Increasing the dosage of anti trichomonal drugs is the main treatment method at present. The aim of this study was to evaluate the efficacy and safety of two oral tinidazole regimens for refractory trichomonas vaginitis.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women be at least 18 years of age
• Failure of conventional treatment (recommended by guidelines including tinidazole, 2g once daily for 5-7 days)

Exclusion criteria

• Allergy to metronidazole or tinidazol
• Pregnant or nursing
• HIV or other chronic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Tinidazole 56

Experimental group

Description:

Tinidazole , 2g， twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.

Treatment:

Drug: Tinidazole 42

Tinidazole 42

Experimental group

Description:

Tinidazole , 1g, three times daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.

Treatment:

Drug: Tinidazole 56