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Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

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.
 
ClinicalTrials.gov Identifier: NCT01832480
Recruitment Status : Completed
First Posted : April 16, 2013
Results First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Patricia Kissinger, Tulane University Health Sciences Center

Tracking Information
First Submitted Date  ICMJE April 4, 2013
First Posted Date  ICMJE April 16, 2013
Results First Submitted Date  ICMJE September 10, 2018
Results First Posted Date  ICMJE February 12, 2019
Last Update Posted Date February 12, 2019
Actual Study Start Date  ICMJE October 6, 2014
Actual Primary Completion Date June 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2019)
Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2013)
TV negative after treatment with either multi or single dose MTZ [ Time Frame: 1 month post treatment completion ]
Change History Complete list of historical versions of study NCT01832480 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
Official Title  ICMJE Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
This was an open label study
Primary Purpose: Treatment
Condition  ICMJE Vaginitis Trichomonal or Due to Trichomonas
Intervention  ICMJE
  • Drug: MTZ 500 mg twice daily x 7 days
    MTZ 500 mg twice daily x 7 days
    Other Name: Multi-dose MTZ
  • Drug: MTZ 2 g
    MTZ 2 g
    Other Name: Single dose MTZ
Study Arms  ICMJE
  • Active Comparator: MTZ 2 g
    Single dose MTZ
    Intervention: Drug: MTZ 2 g
  • Experimental: MTZ 500 mg twice daily x 7 days
    Multi dose MTZ
    Intervention: Drug: MTZ 500 mg twice daily x 7 days
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2017)
623
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2013)
2883
Actual Study Completion Date  ICMJE June 5, 2017
Actual Primary Completion Date June 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01832480
Other Study ID Numbers  ICMJE 4042013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Patricia Kissinger, Tulane University Health Sciences Center
Study Sponsor  ICMJE Tulane University Health Sciences Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patricia Kissinger, MD Tulane Univeristy
PRS Account Tulane University
Verification Date January 2019

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