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

Not Applicable

Not yet recruiting

• Conditions: Trichomonas Vaginitis
• Interventions: Drug: Tinidazole 56; Drug: Tinidazole 42

• Registration Number: NCT05383521
• Lead Sponsor: Shangrong Fan

Brief Summary

We compare two oral tinidazole regimens for refractory trichomonas vaginitis.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-08
• Last Update Posted: 2024-06-11
• Study Start: 2025-12-01
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tinidazole 42	Tinidazole 56	Tinidazole , 1g, three times daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.
Tinidazole 56	Tinidazole 42	Tinidazole , 2g， twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.

Primary Outcome Measures

Name	Time	Method
Cure rate of refractory trichomoniasis	24 weeks	Evaluate the efficacy of oral tinidazole tablets in the treatment of refractory trichomoniasis.Diagnosis of vaginal trichomoniasis is performed by microscopy of vaginal secretions. Cure or failure was based on positive or negative T. vaginalis on vaginal secretions by microscopy examination.

Secondary Outcome Measures

Name	Time	Method
Safety of tinidazole tablets	24 weeks	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. Test of blood routine,liver function, kidney function ,and urine routine will be done before treatment.The same test will be were reviewed within 1 week after treatment.

Trial Locations

Locations (4)

Peking University Shenzhen Hospital; 🇨🇳 Shenzhen, Guangdong, China

Beijing Obstetrics and Gynecology Hospital,Capital Medical University; 🇨🇳 Peking, China

Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University; 🇨🇳 Peking, China

Peking University First Hospital; 🇨🇳 Peking, China