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

Primary Purpose

Trichomonas Vaginitis

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Tinidazole 56

Tinidazole 42

About this trial

This is an interventional treatment trial for Trichomonas Vaginitis focused on measuring Refractory Trichomonas Vaginitis, Tinidazole

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Peking University Shenzhen Hospital
Beijing Obstetrics and Gynecology Hospital,Capital Medical University
Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
Peking University First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Tinidazole 56

Tinidazole 42

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05383521

First Posted

January 5, 2021

Last Updated

May 4, 2023

Sponsor

Shangrong Fan

1. Study Identification

Unique Protocol Identification Number

NCT05383521

Brief Title

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

Official Title

Oral Tinidazole Treatment of Refractory Trichomonas Vaginitis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 1, 2023 (Anticipated)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Shangrong Fan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trichomonas Vaginitis

Keywords

Refractory Trichomonas Vaginitis, Tinidazole

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tinidazole 56

Arm Type

Experimental

Arm Description

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

Arm Title

Tinidazole 42

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Tinidazole 56

Other Intervention Name(s)

Tinidazole M56

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Tinidazole 42

Other Intervention Name(s)

Tinidazole M42

Intervention Description

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

Primary Outcome Measure Information:

Title

Cure rate of refractory trichomoniasis

Description

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Safety of tinidazole tablets

Description

Time Frame

24 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yiheng Liang, M.D.

Phone

86-755-83923333

Ext

5518

13510331823@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ping Liu, M.D.

Phone

86-755-83923333

Ext

5505

253783006@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shangrong Fan Fan, M.D.

Organizational Affiliation

Peking University Shenzhen Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University Shenzhen Hospital

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518000

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yiheng liang, M.D.

Phone

86-755-83923333

Ext

5518

13510331823@163.com

First Name & Middle Initial & Last Name & Degree

Ping liu, M.D.

Phone

86-755-83923333

Ext

5505

253783006@qq.com

First Name & Middle Initial & Last Name & Degree

Shangrong Fan, MD

Facility Name

Beijing Obstetrics and Gynecology Hospital,Capital Medical University

City

Peking

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhaohui Liu, M.D.

First Name & Middle Initial & Last Name & Degree

Zhaohui Liu

Facility Name

Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University

City

Peking

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qinping Liao, M.D.

First Name & Middle Initial & Last Name & Degree

Qinping Liao

Facility Name

Peking University First Hospital

City

Peking

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dai Zhang, M.D.

First Name & Middle Initial & Last Name & Degree

Dai Zhang

12. IPD Sharing Statement

Learn more about this trial

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

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