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

Study Overview
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Brief Summary
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We compare two oral tinidazole regimens for refractory trichomonas vaginitis.

Detailed Description
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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.

Official Title
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Oral Tinidazole Treatment of Refractory Trichomonas Vaginitis

Conditions
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Trichomonas Vaginitis

Intervention / Treatment
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* Drug: Tinidazole 56
* Drug: Tinidazole 42


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tinidazole 56<br>Tinidazole , 2g， twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days. | Drug: Tinidazole 42<br>* Tinidazole , 1g, three times daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.<br>* Other names: Tinidazole M42;|
| Experimental: Tinidazole 42<br>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<br>* Tinidazole , 2g， twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.<br>* Other names: Tinidazole M56;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory Trichomonas Vaginitis, Tinidazole