Trial Outcomes & Findings for Trichomonas Vaginalis Repeat Infections Among HIV Negative Women (NCT NCT01832480)

Last Updated: 2019-02-12

Results Overview

Presence of TV is assessed by nucleic acid amplification test (NAAT) of vaginal swab collected 4 weeks post treatment completion.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

623 participants

Primary outcome timeframe

4 weeks post treatment completion

Results posted on

2019-02-12

Participant Flow

Participant milestones

Participant milestones
Measure	Metronidazole (MTZ) 2 g Single dose MTZ MTZ 2 g: MTZ 2 g	Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Multi dose MTZ MTZ 500 mg twice daily x 7 days
Overall Study STARTED	311	312
Overall Study COMPLETED	270	270
Overall Study NOT COMPLETED	41	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Metronidazole (MTZ) 2 g Single dose MTZ MTZ 2 g: MTZ 2 g	Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Multi dose MTZ MTZ 500 mg twice daily x 7 days
Overall Study Lost to Follow-up	33	30
Overall Study Withdrawal by Subject	0	2
Overall Study post randomization ineligible	8	10

Baseline Characteristics

there were 3 subjects with missing age.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metronidazole (MTZ) 2 g n=311 Participants Single dose MTZ MTZ 2 g: MTZ 2 g	Metronidazole (MTZ) 500 mg BID x 7 Days n=312 Participants Multi dose MTZ MTZ 500 mg BID x 7 days: MTZ 500 mg BID x 7days	Total n=623 Participants Total of all reporting groups
Age, Customized >=30 years	132 Participants n=309 Participants • there were 3 subjects with missing age.	116 Participants n=310 Participants • there were 3 subjects with missing age.	248 Participants n=619 Participants • there were 3 subjects with missing age.
Age, Customized <30 years	178 Participants n=311 Participants • there were 3 subjects with missing age.	193 Participants n=312 Participants • there were 3 subjects with missing age.	371 Participants n=623 Participants • there were 3 subjects with missing age.
Age, Customized missing	2 Participants n=311 Participants • there were 3 subjects with missing age.	1 Participants n=312 Participants • there were 3 subjects with missing age.	3 Participants n=623 Participants • there were 3 subjects with missing age.
Sex: Female, Male Female	311 Participants n=311 Participants	312 Participants n=312 Participants	623 Participants n=623 Participants
Sex: Female, Male Male	0 Participants n=311 Participants	0 Participants n=312 Participants	0 Participants n=623 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=311 Participants	0 Participants n=312 Participants	0 Participants n=623 Participants
Race (NIH/OMB) Asian	0 Participants n=311 Participants	0 Participants n=312 Participants	0 Participants n=623 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=311 Participants	0 Participants n=312 Participants	0 Participants n=623 Participants
Race (NIH/OMB) Black or African American	293 Participants n=311 Participants	298 Participants n=312 Participants	591 Participants n=623 Participants
Race (NIH/OMB) White	12 Participants n=311 Participants	8 Participants n=312 Participants	20 Participants n=623 Participants
Race (NIH/OMB) More than one race	4 Participants n=311 Participants	4 Participants n=312 Participants	8 Participants n=623 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=311 Participants	2 Participants n=312 Participants	4 Participants n=623 Participants
Region of Enrollment United States	311 participants n=311 Participants	312 participants n=312 Participants	623 participants n=623 Participants

PRIMARY outcome

Timeframe: 4 weeks post treatment completion

Population: 570 cases available. Multiple imputation performed for those with missing Test of Cure (TOC) data.

Presence of TV is assessed by nucleic acid amplification test (NAAT) of vaginal swab collected 4 weeks post treatment completion.

Outcome measures

Outcome measures
Measure	Trichomonas (TV) Positive After 2 g Dose n=311 Participants Subjects who were randomized to MTZ singe dose (2g) and tested TV positive at test of cure	Trichomonas (TV) Positive After Metronidazole (MTZ) Multi Dose n=312 Participants Subjects who were randomized to MTZ multi dose (500mg twice daily x 7 days) and tested TV positive at test of cure
Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ)	58 Participants	34 Participants

Adverse Events

Metronidazole (MTZ) 2 g

Serious events: 0 serious events

Other events: 90 other events

Deaths: 0 deaths

Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Dose

Serious events: 2 serious events

Other events: 89 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Metronidazole (MTZ) 2 g n=311 participants at risk This is the control dose arm.	Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Dose n=312 participants at risk This is the experimental dose arm.
Pregnancy, puerperium and perinatal conditions spontaneous abortion	0.00% 0/311 • 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.	0.64% 2/312 • Number of events 2 • 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.

Other adverse events

Additional Information

Patricia Kissinger, Ph.D.

Tulane University School of Public Health and Tropical Medicine

Phone: 504-988-7320

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Metronidazole (MTZ) 2 g n=311 participants at risk This is the control dose arm.	Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Dose n=312 participants at risk This is the experimental dose arm.
Gastrointestinal disorders nausea	19.6% 61/311 • Number of events 61 • 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.	20.2% 63/312 • Number of events 63 • 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.
Nervous system disorders headache	4.8% 15/311 • Number of events 15 • 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.	7.7% 24/312 • Number of events 24 • 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.
Gastrointestinal disorders Vomiting	2.3% 7/311 • Number of events 7 • 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.	4.2% 13/312 • Number of events 13 • 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.
Nervous system disorders Dizziness	5.8% 18/311 • Number of events 18 • 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.	5.1% 16/312 • Number of events 16 • 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.
General disorders Bad taste in mouth	1.9% 6/311 • Number of events 6 • 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.	1.3% 4/312 • Number of events 4 • 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.
Reproductive system and breast disorders Vaginal itching	0.32% 1/311 • Number of events 1 • 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.	0.96% 3/312 • Number of events 3 • 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.
General disorders Fatigue	0.96% 3/311 • Number of events 3 • 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.	0.64% 2/312 • Number of events 2 • 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.
Skin and subcutaneous tissue disorders Rash	0.00% 0/311 • 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.	0.64% 2/312 • Number of events 2 • 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.
Reproductive system and breast disorders Yeast infections	0.32% 1/311 • Number of events 1 • 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.	0.64% 2/312 • Number of events 2 • 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.
Gastrointestinal disorders Stomach Pain	0.64% 2/311 • Number of events 2 • 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.	0.00% 0/312 • 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.
General disorders Verbal intimidation by partner	0.32% 1/311 • Number of events 1 • 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.	0.32% 1/312 • Number of events 1 • 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.
Eye disorders Vision change	0.32% 1/311 • Number of events 1 • 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.	0.00% 0/312 • 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.
Gastrointestinal disorders Persistent nausea/vomiting	0.32% 1/311 • Number of events 1 • 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.	0.00% 0/312 • 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.
Gastrointestinal disorders Increased bowel movements	0.00% 0/311 • 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.	0.32% 1/312 • Number of events 1 • 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.
Nervous system disorders Numbness	0.32% 1/311 • Number of events 1 • 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.	0.32% 1/312 • Number of events 1 • 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.
General disorders Restlessness	0.00% 0/311 • 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.	0.32% 1/312 • Number of events 1 • 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.
Reproductive system and breast disorders Vaginal bleeding	0.32% 1/311 • Number of events 1 • 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.	0.00% 0/312 • 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.
General disorders Loss of appetite	0.32% 1/311 • Number of events 1 • 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.	0.00% 0/312 • 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.
General disorders Depression	0.32% 1/311 • Number of events 1 • 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.	0.32% 1/312 • Number of events 1 • 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.
Gastrointestinal disorders Gas	0.00% 0/311 • 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.	0.32% 1/312 • Number of events 1 • 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.
General disorders Hot flashes	0.32% 1/311 • Number of events 1 • 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.	0.00% 0/312 • 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.
General disorders General feeling sick	0.00% 0/311 • 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.	0.32% 1/312 • Number of events 1 • 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.
General disorders Dry mouth	0.00% 0/311 • 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.	0.32% 1/312 • Number of events 1 • 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.
Renal and urinary disorders Dark urine	0.00% 0/311 • 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.	0.32% 1/312 • Number of events 1 • 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.
Renal and urinary disorders Dysuria	0.32% 1/311 • Number of events 1 • 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.	0.00% 0/312 • 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.
Skin and subcutaneous tissue disorders Peeling skin	0.00% 0/311 • 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.	0.32% 1/312 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Myalagia	0.32% 1/311 • Number of events 1 • 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.	0.00% 0/312 • 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.
General disorders Altered mental state	0.32% 1/311 • Number of events 1 • 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.	0.00% 0/312 • 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.
General disorders Stiff neck	0.00% 0/311 • 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.	0.32% 1/312 • Number of events 1 • 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.