We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01832480
First Posted: April 16, 2013
Last Update Posted: August 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Patricia Kissinger, Tulane University Health Sciences Center
April 4, 2013
April 16, 2013
August 4, 2017
October 6, 2014
June 5, 2017   (Final data collection date for primary outcome measure)
TV negative after treatment with either multi or single dose MTZ [ Time Frame: 4 weeks post treatment completion ]
TV is assessed by nucleic acid amplification technique
TV negative after treatment with either multi or single dose MTZ [ Time Frame: 1 month post treatment completion ]
Complete list of historical versions of study NCT01832480 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
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 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 BID 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).
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
This was an open label study
Primary Purpose: Treatment
Vaginitis Trichomonal or Due to Trichomonas
  • Drug: MTZ 500 mg BID x 7 days
    MTZ 500 mg BID x 7days
    Other Name: Multi-dose MTZ
  • Drug: MTZ 2 g
    MTZ 2 g
    Other Name: Single dose MTZ
  • Active Comparator: MTZ 2 g
    Single dose MTZ
    Intervention: Drug: MTZ 2 g
  • Experimental: MTZ 500 mg BID x 7 days
    Multi dose MTZ
    Intervention: Drug: MTZ 500 mg BID x 7 days

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
623
June 5, 2017
June 5, 2017   (Final data collection date for primary outcome measure)

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 BV at visit
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01832480
4042013
Yes
Not Provided
Plan to Share IPD: No
Patricia Kissinger, Tulane University Health Sciences Center
Tulane University Health Sciences Center
Not Provided
Principal Investigator: Patricia Kissinger, MD Tulane Univeristy
Tulane University
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP