Vaginitis Trichomonal or Due to Trichomonas
Conditions
Keywords
Trichomonas vaginalis, metronidazole
Brief summary
The overall goal of this project is to determine the influence of patient treatment and host factors on repeat Trichomonas vaginalis (TV) infections among HIV-negative women
Detailed description
This study is a phase III randomized clinical trial. HIV-negative women who test positive for TV at their routine gynecological exam at participating clinics will be referred to the nurse/study coordinator to screen for eligibility, provide a description of the study, and obtain written, informed consent (N=700). Subjects will undergo an audio computer assisted self- interview (ACASI), and will self-collect vaginal swabs for Trichomonas testing by InPouch and Nucleic Acid Amplification Test (NAAT), Gram stain testing, and a future microbiome specimen. They will be randomized into one of two arms; metronidazole (MTZ) 2 g single dose (CDC recommended treatment regimen) or MTZ 500 mg twice daily x 7-day dose (CDC alternative treatment regimen). All enrolled women will be scheduled for a follow-up visit at four weeks post treatment completion (window 3-13 weeks).
Interventions
DRUGMTZ 500 mg twice daily x 7 days
MTZ 500 mg twice daily x 7 days
DRUGMTZ 2 g
MTZ 2 g
Sponsors
Tulane University Health Sciences Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This was an open label study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* female * English speaking * \>= 18 years old
Exclusion criteria
* HIV-infected * unable to provide informed consent * pregnant * breast feeding * treated by their provider for Bacterial vaginosis (BV) at visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ) | 4 weeks post treatment completion | Presence of TV is assessed by nucleic acid amplification test (NAAT) of vaginal swab collected 4 weeks post treatment completion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metronidazole (MTZ) 2 g Single dose MTZ
MTZ 2 g: MTZ 2 g | 311 |
| Metronidazole (MTZ) 500 mg BID x 7 Days Multi dose MTZ
MTZ 500 mg BID x 7 days: MTZ 500 mg BID x 7days | 312 |
| Total | 623 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 33 | 30 |
| Overall Study | post randomization ineligible | 8 | 10 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Metronidazole (MTZ) 2 g | Metronidazole (MTZ) 500 mg BID x 7 Days | Total |
|---|---|---|---|
| Age, Customized <30 years | 178 Participants | 193 Participants | 371 Participants |
| Age, Customized >=30 years | 132 Participants | 116 Participants | 248 Participants |
| Age, Customized missing | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 293 Participants | 298 Participants | 591 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 12 Participants | 8 Participants | 20 Participants |
| Region of Enrollment United States | 311 participants | 312 participants | 623 participants |
| Sex: Female, Male Female | 311 Participants | 312 Participants | 623 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 311 | 0 / 312 |
| other Total, other adverse events | 90 / 311 | 89 / 312 |
| serious Total, serious adverse events | 0 / 311 | 2 / 312 |
Outcome results
Primary
Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ)
Presence of TV is assessed by nucleic acid amplification test (NAAT) of vaginal swab collected 4 weeks post treatment completion.
Time frame: 4 weeks post treatment completion
Population: 570 cases available. Multiple imputation performed for those with missing Test of Cure (TOC) data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Trichomonas (TV) Positive After 2 g Dose | Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ) | 58 Participants |
| Trichomonas (TV) Positive After Metronidazole (MTZ) Multi Dose | Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ) | 34 Participants |