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

June 8, 2024 updated by: Shangrong Fan

Oral Tinidazole Treatment of Refractory Trichomonas Vaginitis

We compare two oral tinidazole regimens for refractory trichomonas vaginitis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ping liu, M.D.
  • Phone Number: 5505 86-755-83923333
  • Email: 253783006@qq.com

Study Contact Backup

Study Locations

  • China
      • Peking, China
        • Peking University First Hospital
        • Contact:
          • Dai Zhang, M.D.
        • Principal Investigator:
          • Dai Zhang
      • Peking, China
        • Beijing Obstetrics and Gynecology Hospital,Capital Medical University
        • Principal Investigator:
          • Zhaohui Liu
        • Contact:
          • Zhaohui Liu, M.D.
      • Peking, China
        • Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
        • Contact:
          • Qinping Liao, M.D.
        • Principal Investigator:
          • Qinping Liao
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Peking University Shenzhen Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shangrong Fan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure rate of refractory trichomoniasis
Time Frame: 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.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of tinidazole tablets
Time Frame: 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.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shangrong Fan

Investigators

  • Principal Investigator: Shangrong Fan Fan, M.D., Peking University Shenzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

May 19, 2022

First Posted (Actual)

May 20, 2022

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 8, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PUSZH001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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