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

Trichomonas Vaginitis Clinical Trial

Official title:

Oral Tinidazole Treatment of Refractory Trichomonas Vaginitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05383521
• Other study ID #: 2020PUSZH001
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: Peking University Shenzhen Hospital
• Contact: Yiheng Liang, M.D.
• Phone: 86-755-83923333
• Email: 13510331823[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We compare two oral tinidazole regimens for refractory trichomonas vaginitis.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Trichomonas Infections
• Trichomonas Vaginitis
• Vaginitis

Intervention

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

Locations

Country	Name	City	State
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	Peking University Shenzhen Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shangrong Fan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rate of refractory trichomoniasis	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.	24 weeks
Secondary	Safety of tinidazole tablets	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.	24 weeks