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Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

Primary Purpose

Vaginitis Trichomonal or Due to Trichomonas

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MTZ 500 mg twice daily x 7 days
MTZ 2 g
Sponsored by
Tulane University Health Sciences Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginitis Trichomonal or Due to Trichomonas focused on measuring Trichomonas vaginalis, metronidazole

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jefferson County Dept of Health/STD Specialty Clinic
  • CrescentCare Health and Wellness Center
  • Crossroads Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

MTZ 2 g

MTZ 500 mg twice daily x 7 days

Arm Description

Single dose MTZ

Multi dose MTZ

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 4, 2013
Last Updated
January 22, 2019
Sponsor
Tulane University Health Sciences Center
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1. Study Identification

Unique Protocol Identification Number
NCT01832480
Brief Title
Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
Official Title
Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 6, 2014 (Actual)
Primary Completion Date
June 5, 2017 (Actual)
Study Completion Date
June 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tulane University Health Sciences Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginitis Trichomonal or Due to Trichomonas
Keywords
Trichomonas vaginalis, metronidazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
This was an open label study
Allocation
Randomized
Enrollment
623 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MTZ 2 g
Arm Type
Active Comparator
Arm Description
Single dose MTZ
Arm Title
MTZ 500 mg twice daily x 7 days
Arm Type
Experimental
Arm Description
Multi dose MTZ
Intervention Type
Drug
Intervention Name(s)
MTZ 500 mg twice daily x 7 days
Other Intervention Name(s)
Multi-dose MTZ
Intervention Description
MTZ 500 mg twice daily x 7 days
Intervention Type
Drug
Intervention Name(s)
MTZ 2 g
Other Intervention Name(s)
Single dose MTZ
Intervention Description
MTZ 2 g
Primary Outcome Measure Information:
Title
Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ)
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Kissinger, MD
Organizational Affiliation
Tulane Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jefferson County Dept of Health/STD Specialty Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
CrescentCare Health and Wellness Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Crossroads Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19008776
Citation
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.
Results Reference
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PubMed Identifier
18444815
Citation
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.
Results Reference
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PubMed Identifier
16531939
Citation
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.
Results Reference
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PubMed Identifier
21423852
Citation
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.
Results Reference
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PubMed Identifier
27898571
Citation
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.
Results Reference
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PubMed Identifier
26602621
Citation
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.
Results Reference
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PubMed Identifier
26242185
Citation
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.
Results Reference
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Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

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