Vaginitis Trichomonal or Due to TrichomonasPhase 3NCT01832480
Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
A Phase 3 study testing MTZ 500 mg twice daily x 7 days and MTZ 2 g in people with Vaginitis Trichomonal or Due to Trichomonas, run by Tulane University Health Sciences Center at 3 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginitis Trichomonal or Due to Trichomonas
- What is being tested?
- MTZ 500 mg twice daily x 7 days and MTZ 2 g
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 623 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Oct 2014to 5 Jun 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female
- English speaking
- >= 18 years old
Who cannot join
- HIV-infected
- unable to provide informed consent
- pregnant
- breast feeding
- treated by their provider for Bacterial vaginosis (BV) at visit
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Jefferson County Dept of Health/STD Specialty Clinic
Birmingham, Alabama, 35233
Crossroads Clinic
Jackson, Mississippi, 39213
CrescentCare Health and Wellness Center
New Orleans, Louisiana, 70119
About this study
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
Read the 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).
- Being tested
- MTZ 500 mg twice daily x 7 days, MTZ 2 g
- Keywords
- Trichomonas vaginalis, metronidazole
- Medical subject headings
- Trichomonas Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTZ 500 mg twice daily x 7 daysDrug
Also called Multi-dose MTZ
MTZ 500 mg twice daily x 7 days
MTZ 2 gDrug
Also called Single dose MTZ
MTZ 2 g
| Study group | Role | What they receive |
|---|---|---|
| MTZ 2 g | Active comparator | Single dose MTZ Receives: Drug: MTZ 2 g |
| MTZ 500 mg twice daily x 7 days | Experimental | Multi dose MTZ Receives: Drug: MTZ 500 mg twice daily x 7 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks post treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study start6 Oct 2014
- Primary completion5 Jun 2017
- Study completion5 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Vaginitis Trichomonal or Due to TrichomonasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 623 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Kissinger, Tulane University Health Sciences Center
- Investigators
- Patricia Kissinger, MD, Principal investigator, Tulane Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832480
- Sponsor's protocol ID
- 4042013
- Status last verified
- Jan 2019
- First submitted
- 4 Apr 2013
- Last updated
- 12 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 19008776Kissinger 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.
PubMed 18444815Kissinger 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.
PubMed 16531939Kissinger 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.
PubMed 21423852Howe 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.
PubMed 27898571Meites 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.
PubMed 26602621Kissinger 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.
PubMed 26242185
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
- ClinicalTrials.gov ID
- NCT01832480
- Acronym / sponsor ID
- 4042013
- Keywords
- Trichomonas vaginalis, metronidazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 623 participants (actual)
- Lead sponsor
- Tulane University Health Sciences CenterUniversity, hospital or other
- Study start
- 6 Oct 2014 (actual)
- Primary completion
- 5 Jun 2017 (actual)
- Study completion
- 5 Jun 2017 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Posted 12 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTZ 2 g | Active comparator | Drug: MTZ 2 gSingle dose MTZ |
| MTZ 500 mg twice daily x 7 days | Experimental | Drug: MTZ 500 mg twice daily x 7 daysMulti dose MTZ |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female
- English speaking
- >= 18 years old
Key exclusion criteria (5 listed)
- HIV-infected
- unable to provide informed consent
- pregnant
- breast feeding
- treated by their provider for Bacterial vaginosis (BV) at visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTZ 500 mg twice daily x 7 daysAlso: Multi-dose MTZMTZ 500 mg twice daily x 7 days | Drug | MTZ 500 mg twice daily x 7 days |
| MTZ 2 gAlso: Single dose MTZMTZ 2 g | Drug | MTZ 2 g |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19008776Kissinger 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.
- Background: PubMed 18444815Kissinger 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.
- Background: PubMed 16531939Kissinger 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.
- Background: PubMed 21423852Kissinger 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.
- Background: PubMed 27898571Howe 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.
- Background: PubMed 26602621Meites 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.
- Background: PubMed 26242185Kissinger 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Kissinger, MD principal investigator
Tulane Univeristy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MTZ 500 mg twice daily x 7 days and MTZ 2 g in people with Vaginitis Trichomonal or Due to Trichomonas, run by Tulane University Health Sciences Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ) (time frame: 4 weeks post treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01832480, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.