Trichomonas InfectionsPhase 4NCT01018095
Trichomonas Vaginalis Recurrence Among HIV+ Women
A Phase 4 study testing Metronidazole in people with Trichomonas Infections and HIV Infections, run by Tulane University Health Sciences Center at 5 sites in United States.
Trial summary
The purpose of this study is to determine if the 2 gram single dose of metronidazole is as effective as the 7 day 500 mg BID dose for treatment of Trichomonas vaginalis (TV) among HIV-infected women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Trichomonas Infections, HIV Infections
- What is being tested?
- Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2005to Aug 2009
- Phase
- Phase 4
- 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
- 18 years or older
- HIV-positive
- TV positive by either wet preparation or culture
- ability to refrain from all alcohol use for 24 hours before and after taking oral metronidazole
- willing to take metronidazole treatment
Who cannot join
- pregnant
- incarcerated
- previously enrolled
- currently taking disulfiram
- alcoholism or known liver damage
- medical contraindications to metronidazole
- treated with metronidazole within the previous 14 days
- requires treatment for B.V. per Amsel's criteria
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Thomas St Clinic
Houston, Texas, 77009
Northwest Clinic
Houston, Texas, 77040
Crossroads Clinic
Jackson, Mississippi, 39216
HIV Outpatient Clinic
New Orleans, Louisiana, 70112
NOAIDS
New Orleans, Louisiana, 70119
About this study
Official title: Randomized Phase IV Trial of Metronidazole Single Dose Versus 7 Day Dose for Treatment of Trichomonas Vaginalis Among HIV-infected Women
The purpose of this study is to determine if the 2 gram single dose of metronidazole is as effective as the 7 day 500 mg BID dose for treatment of Trichomonas vaginalis (TV) among HIV-infected women.
Read the detailed description
This is a Phase IV equivalency trial as both doses of metronidazole are listed in the the Centers for Disease Control and Prevention Treatment Guidelines for the treatment of T vaginalis.
- Conditions
- Trichomonas Infections, HIV Infections
- Being tested
- Metronidazole
- Medical subject headings
- Trichomonas Infections, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Also called Flagyl
2 gm single dose versus 7 day 500 mg BID dose
| Study group | Role | What they receive |
|---|---|---|
| Single dose | Active comparator | Metronidazole 2 gm single dose Receives: Drug: Metronidazole |
| 7 day dose | Active comparator | Metronidazole 500 mg dose x 7 days Receives: Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
TV Culture Positive Result
At the participants' test of cure (TOC) visits they were screened for Trichomonas vaginalis using (InPouch) culture. Presence of parasite will yield a culture positive result.
Measured: test-of-cure visit at 6-12 days post-treatment completion
Secondary outcomes (1)
TV Culture Positive Result
Participants who returned for their follow up visits were tested for Trichomonas vaginalis using InPouch culture. If parasites are present, it will yield a culture positive result.
Measured: 3 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startMay 2005
- Primary completionJul 2009
- Study completionAug 2009
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 (2)Papers the sponsor has linked to this study.
- Other trials for Trichomonas InfectionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 270 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, Ph.D., Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018095
- Sponsor's protocol ID
- 543793
- Other IDs
- U19AI061972
- Status last verified
- Dec 2016
- First submitted
- 20 Nov 2009
- Last updated
- 20 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kissinger P, Muzny CA, Mena LA, Lillis RA, Schwebke JR, Beauchamps L, Taylor SN, Schmidt N, Myers L, Augostini P, Secor WE, Bradic M, Carlton JM, Martin DH. Single-dose versus 7-day-dose metronidazole for the treatment of trichomoniasis in women: an open-label, randomised controlled trial. Lancet Infect Dis. 2018 Nov;18(11):1251-1259. doi: 10.1016/S1473-3099(18)30423-7. Epub 2018 Oct 5.
PubMed 30297322Kissinger 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 21423852
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase IV Trial of Metronidazole Single Dose Versus 7 Day Dose for Treatment of Trichomonas Vaginalis Among HIV-infected Women
- ClinicalTrials.gov ID
- NCT01018095
- Acronym / sponsor ID
- 543793
- Conditions
- Trichomonas Infections, HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Tulane University Health Sciences CenterUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- May 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 23 Nov 2009 (estimated)
- Results
- Posted 15 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the 2 gram single dose of metronidazole is as effective as the 7 day 500 mg BID dose for treatment of Trichomonas vaginalis (TV) among HIV-infected women.
Detailed description
This is a Phase IV equivalency trial as both doses of metronidazole are listed in the the Centers for Disease Control and Prevention Treatment Guidelines for the treatment of T vaginalis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single dose | Active comparator | Drug: MetronidazoleMetronidazole 2 gm single dose |
| 7 day dose | Active comparator | Drug: MetronidazoleMetronidazole 500 mg dose x 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female
- 18 years or older
- HIV-positive
- TV positive by either wet preparation or culture
- ability to refrain from all alcohol use for 24 hours before and after taking oral metronidazole
Key exclusion criteria (8 listed)
- pregnant
- incarcerated
- previously enrolled
- currently taking disulfiram
- alcoholism or known liver damage
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 |
|---|---|---|
| MetronidazoleAlso: Flagyl2 gm single dose versus 7 day 500 mg BID dose | Drug | 7 day dose, Single dose |
Primary outcome
TV Culture Positive Result
Time frame: test-of-cure visit at 6-12 days post-treatment completion
At the participants' test of cure (TOC) visits they were screened for Trichomonas vaginalis using (InPouch) culture. Presence of parasite will yield a culture positive result.
1 secondary outcome
TV Culture Positive Result
Time frame: 3 months post-enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30297322Kissinger P, Muzny CA, Mena LA, Lillis RA, Schwebke JR, Beauchamps L, Taylor SN, Schmidt N, Myers L, Augostini P, Secor WE, Bradic M, Carlton JM, Martin DH. Single-dose versus 7-day-dose metronidazole for the treatment of trichomoniasis in women: an open-label, randomised controlled trial. Lancet Infect Dis. 2018 Nov;18(11):1251-1259. doi: 10.1016/S1473-3099(18)30423-7. Epub 2018 Oct 5.
- Derived from this study: 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.
- Individual participant dataSharing planned: No
Related trials for Trichomonas Infections
Recruiting
The Integrated Female Sexually Transmitted Infection Testing for HIV Epidemic Control Through PrEP (IN-STEP) Study
Gonorrhea Female, Chlamydia Females
Recruiting
Improving Maternal and Child Health Through Point-of-care STI Testing
Treponema Pallidum Infection, Chlamydia Trachomatis Infection
RecruitingPhase 3
STI Testing to Enhance PrEP Use in Pregnancy
PrEP Adherence, Sexually Transmitted Infections (STIs)
RecruitingPhase 4
Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole
Trichomonas Vaginitis, Bacterial Vaginitis
Active, not recruiting
Point-of-care Tests for Vaginal Discharge in Nepal
Vaginal Discharge, Sexually Transmitted Diseases
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, Ph.D. principal investigator
Tulane University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metronidazole in people with Trichomonas Infections and HIV Infections, run by Tulane University Health Sciences Center at 5 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 6 inclusion and 8 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 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 15 Jul 2013). 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?
TV Culture Positive Result (time frame: test-of-cure visit at 6-12 days 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 NCT01018095, which also lists 2 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 20 Dec 2016.