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Trial record 9 of 54 for:    "Vaginitis" | "Metronidazole"

Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Vaginitis Trichomonal or Due to Trichomonas
Interventions Drug: MTZ 500 mg twice daily x 7 days
Drug: MTZ 2 g
Enrollment 623
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Metronidazole (MTZ) 2 g Metronidazole (MTZ) 500 mg Twice Daily x 7 Days
Hide Arm/Group Description

Single dose MTZ

MTZ 2 g: MTZ 2 g

Multi dose MTZ

MTZ 500 mg twice daily x 7 days

Period Title: Overall Study
Started 311 312
Completed 270 270
Not Completed 41 42
Reason Not Completed
Lost to Follow-up             33             30
Withdrawal by Subject             0             2
post randomization ineligible             8             10
Arm/Group Title Metronidazole (MTZ) 2 g Metronidazole (MTZ) 500 mg BID x 7 Days Total
Hide Arm/Group Description

Single dose MTZ

MTZ 2 g: MTZ 2 g

Multi dose MTZ

MTZ 500 mg BID x 7 days: MTZ 500 mg BID x 7days

Total of all reporting groups
Overall Number of Baseline Participants 311 312 623
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
>=30 years Number Analyzed 309 participants 310 participants 619 participants
132
  42.7%
116
  37.4%
248
  40.1%
<30 years Number Analyzed 311 participants 312 participants 623 participants
178
  57.2%
193
  61.9%
371
  59.6%
missing Number Analyzed 311 participants 312 participants 623 participants
2
   0.6%
1
   0.3%
3
   0.5%
[1]
Measure Analysis Population Description: there were 3 subjects with missing age.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 311 participants 312 participants 623 participants
Female
311
 100.0%
312
 100.0%
623
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 311 participants 312 participants 623 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
293
  94.2%
298
  95.5%
591
  94.9%
White
12
   3.9%
8
   2.6%
20
   3.2%
More than one race
4
   1.3%
4
   1.3%
8
   1.3%
Unknown or Not Reported
2
   0.6%
2
   0.6%
4
   0.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 311 participants 312 participants 623 participants
311 312 623
1.Primary Outcome
Title Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
570 cases available. Multiple imputation performed for those with missing Test of Cure (TOC) data.
Arm/Group Title Trichomonas (TV) Positive After 2 g Dose Trichomonas (TV) Positive After Metronidazole (MTZ) Multi Dose
Hide Arm/Group Description:
Subjects who were randomized to MTZ singe dose (2g) and tested TV positive at test of cure
Subjects who were randomized to MTZ multi dose (500mg twice daily x 7 days) and tested TV positive at test of cure
Overall Number of Participants Analyzed 311 312
Measure Type: Count of Participants
Unit of Measure: Participants
58
  18.6%
34
  10.9%
Time Frame 4 weeks post completion of treatment
Adverse Event Reporting Description 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.
 
Arm/Group Title Metronidazole (MTZ) 2 g Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Dose
Hide Arm/Group Description This is the control dose arm. This is the experimental dose arm.
All-Cause Mortality
Metronidazole (MTZ) 2 g Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/311 (0.00%)      0/312 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Metronidazole (MTZ) 2 g Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/311 (0.00%)      2/312 (0.64%)    
Pregnancy, puerperium and perinatal conditions     
spontaneous abortion  [1]  0/311 (0.00%)  0 2/312 (0.64%)  2
Indicates events were collected by systematic assessment
[1]
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
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metronidazole (MTZ) 2 g Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   90/311 (28.94%)      89/312 (28.53%)    
Eye disorders     
Vision change   1/311 (0.32%)  1 0/312 (0.00%)  0
Gastrointestinal disorders     
nausea   61/311 (19.61%)  61 63/312 (20.19%)  63
Vomiting   7/311 (2.25%)  7 13/312 (4.17%)  13
Stomach Pain   2/311 (0.64%)  2 0/312 (0.00%)  0
Persistent nausea/vomiting  [1]  1/311 (0.32%)  1 0/312 (0.00%)  0
Increased bowel movements   0/311 (0.00%)  0 1/312 (0.32%)  1
Gas   0/311 (0.00%)  0 1/312 (0.32%)  1
General disorders     
Bad taste in mouth   6/311 (1.93%)  6 4/312 (1.28%)  4
Fatigue   3/311 (0.96%)  3 2/312 (0.64%)  2
Verbal intimidation by partner   1/311 (0.32%)  1 1/312 (0.32%)  1
Restlessness   0/311 (0.00%)  0 1/312 (0.32%)  1
Loss of appetite   1/311 (0.32%)  1 0/312 (0.00%)  0
Depression  [2]  1/311 (0.32%)  1 1/312 (0.32%)  1
Hot flashes   1/311 (0.32%)  1 0/312 (0.00%)  0
General feeling sick   0/311 (0.00%)  0 1/312 (0.32%)  1
Dry mouth   0/311 (0.00%)  0 1/312 (0.32%)  1
Altered mental state   1/311 (0.32%)  1 0/312 (0.00%)  0
Stiff neck   0/311 (0.00%)  0 1/312 (0.32%)  1
Musculoskeletal and connective tissue disorders     
Myalagia   1/311 (0.32%)  1 0/312 (0.00%)  0
Nervous system disorders     
headache  1  15/311 (4.82%)  15 24/312 (7.69%)  24
Dizziness   18/311 (5.79%)  18 16/312 (5.13%)  16
Numbness   1/311 (0.32%)  1 1/312 (0.32%)  1
Renal and urinary disorders     
Dark urine   0/311 (0.00%)  0 1/312 (0.32%)  1
Dysuria   1/311 (0.32%)  1 0/312 (0.00%)  0
Reproductive system and breast disorders     
Vaginal itching   1/311 (0.32%)  1 3/312 (0.96%)  3
Yeast infections   1/311 (0.32%)  1 2/312 (0.64%)  2
Vaginal bleeding   1/311 (0.32%)  1 0/312 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash   0/311 (0.00%)  0 2/312 (0.64%)  2
Peeling skin   0/311 (0.00%)  0 1/312 (0.32%)  1
1
Term from vocabulary, headache
Indicates events were collected by systematic assessment
[1]
This was recorded as a single adverse event
[2]
Not clinically assessed, described as feeling low
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Patricia Kissinger, Ph.D.
Organization: Tulane University School of Public Health and Tropical Medicine
Phone: 504-988-7320
Publications:
Responsible Party: Patricia Kissinger, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01832480     History of Changes
Other Study ID Numbers: 4042013
First Submitted: April 4, 2013
First Posted: April 16, 2013
Results First Submitted: September 10, 2018
Results First Posted: February 12, 2019
Last Update Posted: February 12, 2019