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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MTZ 2 g | Active Comparator | Single dose MTZ |
|
| MTZ 500 mg twice daily x 7 days | Experimental | Multi dose MTZ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MTZ 500 mg twice daily x 7 days | Drug | MTZ 500 mg twice daily x 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks post treatment completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Kissinger, MD | Tulane Univeristy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson County Dept of Health/STD Specialty Clinic | Birmingham | Alabama | 35233 | United States | ||
| CrescentCare Health and Wellness Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19008776 | Background | Kissinger P, Amedee A, Clark RA, Dumestre J, Theall KP, Myers L, Hagensee ME, Farley TA, Martin DH. Trichomonas vaginalis treatment reduces vaginal HIV-1 shedding. Sex Transm Dis. 2009 Jan;36(1):11-6. doi: 10.1097/OLQ.0b013e318186decf. | |
| 18444815 | Background | Kissinger P, Secor WE, Leichliter JS, Clark RA, Schmidt N, Curtin E, Martin DH. Early repeated infections with Trichomonas vaginalis among HIV-positive and HIV-negative women. Clin Infect Dis. 2008 Apr 1;46(7):994-9. doi: 10.1086/529149. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metronidazole (MTZ) 2 g | Single dose MTZ MTZ 2 g: MTZ 2 g |
| FG001 | Metronidazole (MTZ) 500 mg Twice Daily x 7 Days | Multi dose MTZ MTZ 500 mg twice daily x 7 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metronidazole (MTZ) 2 g | Single dose MTZ MTZ 2 g: MTZ 2 g |
| BG001 | Metronidazole (MTZ) 500 mg BID x 7 Days | Multi dose MTZ MTZ 500 mg BID x 7 days: MTZ 500 mg BID x 7days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | there were 3 subjects with missing age. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 570 cases available. Multiple imputation performed for those with missing Test of Cure (TOC) data. | Posted | Count of Participants | Participants | 4 weeks post treatment completion |
|
4 weeks post completion of treatment
A standard event reporting form will be used by all sites. In the event of an adverse event, the form was filled out by study personnel within 24 hours of the reporting of the event and sent to the investigators for review.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metronidazole (MTZ) 2 g | This is the control dose arm. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| spontaneous abortion | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | women tested negative for pregnancy at baseline but were found to be pregnant at follow-up and had a spontaneous abortion that may or may not have been a results of the medication |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Kissinger, Ph.D. | Tulane University School of Public Health and Tropical Medicine | 504-988-7320 | kissing@tulane.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 2, 2017 | Jan 15, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014247 | Trichomonas Vaginitis |
| ID | Term |
|---|---|
| D014245 | Trichomonas Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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This was an open label study
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| MTZ 2 g | Drug | MTZ 2 g |
|
|
| New Orleans |
| Louisiana |
| 70119 |
| United States |
| Crossroads Clinic | Jackson | Mississippi | 39213 | United States |
| 16531939 | Background | Kissinger P, Schmidt N, Mohammed H, Leichliter JS, Gift TL, Meadors B, Sanders C, Farley TA. Patient-delivered partner treatment for Trichomonas vaginalis infection: a randomized controlled trial. Sex Transm Dis. 2006 Jul;33(7):445-50. doi: 10.1097/01.olq.0000204511.84485.4c. |
| 21423852 | Background | Kissinger P, Mena L, Levison J, Clark RA, Gatski M, Henderson H, Schmidt N, Rosenthal SL, Myers L, Martin DH. A randomized treatment trial: single versus 7-day dose of metronidazole for the treatment of Trichomonas vaginalis among HIV-infected women. J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):565-71. doi: 10.1097/QAI.0b013e3181eda955. |
| 27898571 | Background | Howe K, Kissinger PJ. Single-Dose Compared With Multidose Metronidazole for the Treatment of Trichomoniasis in Women: A Meta-Analysis. Sex Transm Dis. 2017 Jan;44(1):29-34. doi: 10.1097/OLQ.0000000000000537. |
| 26602621 | Background | Meites E, Gaydos CA, Hobbs MM, Kissinger P, Nyirjesy P, Schwebke JR, Secor WE, Sobel JD, Workowski KA. A Review of Evidence-Based Care of Symptomatic Trichomoniasis and Asymptomatic Trichomonas vaginalis Infections. Clin Infect Dis. 2015 Dec 15;61 Suppl 8(Suppl 8):S837-48. doi: 10.1093/cid/civ738. |
| 26242185 | Background | Kissinger P. Trichomonas vaginalis: a review of epidemiologic, clinical and treatment issues. BMC Infect Dis. 2015 Aug 5;15:307. doi: 10.1186/s12879-015-1055-0. |
| post randomization ineligible |
|
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects who were randomized to MTZ multi dose (500mg twice daily x 7 days) and tested TV positive at test of cure
|
|
| 311 |
| 0 |
| 311 |
| 90 |
| 311 |
| EG001 | Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Dose | This is the experimental dose arm. | 0 | 312 | 2 | 312 | 89 | 312 |
|
| headache | Nervous system disorders | headache | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Bad taste in mouth | General disorders | Systematic Assessment |
|
| Vaginal itching | Reproductive system and breast disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Yeast infections | Reproductive system and breast disorders | Systematic Assessment |
|
| Stomach Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Verbal intimidation by partner | General disorders | Systematic Assessment |
|
| Vision change | Eye disorders | Systematic Assessment |
|
| Persistent nausea/vomiting | Gastrointestinal disorders | Systematic Assessment | This was recorded as a single adverse event |
|
| Increased bowel movements | Gastrointestinal disorders | Systematic Assessment |
|
| Numbness | Nervous system disorders | Systematic Assessment |
|
| Restlessness | General disorders | Systematic Assessment |
|
| Vaginal bleeding | Reproductive system and breast disorders | Systematic Assessment |
|
| Loss of appetite | General disorders | Systematic Assessment |
|
| Depression | General disorders | Systematic Assessment | Not clinically assessed, described as feeling low |
|
| Gas | Gastrointestinal disorders | Systematic Assessment |
|
| Hot flashes | General disorders | Systematic Assessment |
|
| General feeling sick | General disorders | Systematic Assessment |
|
| Dry mouth | General disorders | Systematic Assessment |
|
| Dark urine | Renal and urinary disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Peeling skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Myalagia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Altered mental state | General disorders | Systematic Assessment |
|
| Stiff neck | General disorders | Systematic Assessment |
|
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| D014627 |
| Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|