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

Sponsor

Shangrong Fan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05383521

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We compare two oral tinidazole regimens for refractory trichomonas vaginitis.

Condition or Disease	Intervention/Treatment	Phase
Trichomonas Vaginitis	Drug: Tinidazole 56 Drug: Tinidazole 42	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

For patients who failed to conventional treatment (recommended by the guidelines including tinidazole, 2g once daily for 5-7 days), the following regimens were selected: Tinidazole , 2g twice daily for 14 days. At the same time, metronidazole, 400 mg, daily, vaginal administration for 14 days. Tinidazole , 1g three times daily for 14 days. At the same time, metronidazole, 400 mg, daily, vaginal administration for 14 days.For patients who failed to conventional treatment (recommended by the guidelines including tinidazole, 2g once daily for 5-7 days), the following regimens were selected: Tinidazole , 2g twice daily for 14 days. At the same time, metronidazole, 400 mg, daily, vaginal administration for 14 days. Tinidazole , 1g three times daily for 14 days. At the same time, metronidazole, 400 mg, daily, vaginal administration for 14 days.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Oral Tinidazole Treatment of Refractory Trichomonas Vaginitis

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tinidazole 56 Tinidazole , 2g， twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.	Drug: Tinidazole 42 Tinidazole , 1g, three times daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days. Other Names: Tinidazole M42
Experimental: Tinidazole 42 Tinidazole , 1g, three times daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.	Drug: Tinidazole 56 Tinidazole , 2g， twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days. Other Names: Tinidazole M56

Arm

Intervention/Treatment

Experimental: Tinidazole 56

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

Drug: Tinidazole 42

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

Other Names:

Tinidazole M42

Experimental: Tinidazole 42

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

Drug: Tinidazole 56

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

Other Names:

Tinidazole M56

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Shenzhen Hospital	Shenzhen	Guangdong	China	518000
2	Beijing Obstetrics and Gynecology Hospital,Capital Medical University	Peking		China
3	Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University	Peking		China
4	Peking University First Hospital	Peking		China