Trichomonas Infection
Conditions
Keywords
Vaginal Itching, Vaginal Discharge
Brief summary
This is a Phase 3, multi-center, prospective, randomized, placebo-controlled, delayed treatment, double-blind, study to evaluate the effectiveness, and safety of a single, oral dose of Solosec® containing 2 grams of secnidazole in female patients with trichomoniasis.
Detailed description
The study will consist of a primary study phase (Visit 1 (baseline) to Visit 2 (Day 6-12)) and a follow-up phase (Visit 2 to Visit 3 (7-12 days post Visit 2)). During the primary phase patients will be randomly assigned in a 1:1 ratio to either Solosec or placebo. Patients will return to the clinic for the test of cure (TOC) visit to be conducted on Days 6-12 (Visit 2). To ensure all patients receive treatment and to maintain the double-blind, after completion of the primary phase, patients will receive the opposite treatment , (placebo patients will receive Solosec and vice versa). Patients with V2 cultures that are subsequently positive for T. vaginalis will return to the clinic for Visit 3 (V3) assessments and investigator assessment of need for additional therapy (an additional Visit 4 may be scheduled at the investigator's discretion if culture at V3 is positive). Summary of results includes data reported during the primary phase of the study \[Visit 1 (baseline) to Visit 2/TOC (Day 6-12)\]
Interventions
DRUGSecnidazole
Oral Granules containing secnidazole
DRUGPlacebo
Oral Granules of placebo manufactured to mimic secnidazole
Sponsors
Lupin Research Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
For primary phase of study, patients were randomly assigned in a 1:1 ratio to either Solosec or Placebo.
Eligibility
Sex/Gender
FEMALE
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult female or post-menarche adolescent girl ≥12 years of age in general good health * Have a diagnosis of trichomoniasis at the screening visit as determined by one of the following: * positive T. vaginalis NAAT test within 30 days of screening for which treatment has not been initiated. * positive OSOM® rapid test. * positive wet mount assessment. * Agree to abstain from vaginal intercourse until the final study visit * Agree not to have any vaginal penetration or use of any vaginal products for the duration of the study
Exclusion criteria
* Are pregnant, lactating, or planning to become pregnant during the study. * Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including symptomatic vulvovaginal candidiasis, chlamydia, gonorrhea, or an active genital herpes outbreak * Are suspected clinically of having an acute urinary tract infection. * Have active genital lesions, including primary syphilitic chancres and herpes simplex virus lesions, or other vaginal or vulvar conditions which could confound the interpretation of the clinical response, as determined by the Investigator (patients with genital warts may be enrolled). * Have received systemic antibacterial therapy or topical antimicrobial/antifungal/ immunomodulatory therapies in the genital area (vagina, vulva and surrounding soft tissue), within 14 days prior to the Baseline Visit (Day 1).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological Cure at the TOC Visit | Study Day 6-12 | Vaginal Culture negative for T. vaginalis at TOC Visit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Solosec 2 Grams Orally administered as a single dose with applesauce.
Secnidazole: Oral Granules containing secnidazole then | 74 |
| Placebo Orally administered as a single dose with applesauce.
Placebo: Oral Granules of placebo manufactured to mimic secnidazole then | 73 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Solosec 2 Grams | Total | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 74 Participants | 146 Participants | 72 Participants |
| Age, Continuous | 36.5 years STANDARD_DEVIATION 0 | 37.6 years STANDARD_DEVIATION 0 | 38.6 years STANDARD_DEVIATION 0 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 72 Participants | 143 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants for Modified intent to treat population | 64 Participants | 131 Participants | 67 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 68 Participants | 134 Participants | 66 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 10 Participants | 6 Participants |
| Region of Enrollment United States | 74 participants | 147 participants | 73 participants |
| Sex: Female, Male Female | 74 Participants | 147 Participants | 73 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 73 |
| other Total, other adverse events | 6 / 74 | 14 / 73 |
| serious Total, serious adverse events | 0 / 74 | 0 / 73 |
Outcome results
Primary
Microbiological Cure at the TOC Visit
Vaginal Culture negative for T. vaginalis at TOC Visit
Time frame: Study Day 6-12
Population: Modified Intent to Treat Population (Patients with culture positive for T. vaginalis at baseline)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Solosec 2 Grams | Microbiological Cure at the TOC Visit | 59 Participants |
| Placebo | Microbiological Cure at the TOC Visit | 1 Participants |