None listed
Conditions
Interventions
Nitazoxanide Type of group
Each patient will blindly receive six 500mg tablets of Nitazoxanide and four tablets of a Metronidazole placebo. Then, follow-up evaluations of adverse experiences will be carried out on the first and third post-treatment days. A final evaluation of the cure will be carried out on the seventh day post-treatment, which will include a sampling for T. Vaginalis and the evaluation of symptoms and adverse experiences.
Group name:metronidazole Type of group
They will receive six tablets of a Nitazoxanide placebo and four 500 mg tablets of Metronidazole.
Follow-up evaluations of adverse experiences will be carried out on the first and third post-treatment days. A final evaluation of the cure will be carried out on the seventh day post-treatment, which will include a sampling for T. Vaginalis and the
evaluation of symptoms and adverse experiences.
Sponsors
ASOCIACION BENEFICA PRISMA,
Eligibility
Inclusion criteria
Inclusion criteria: • Patients 18 years of age or older, with vaginal discharge. • Presence of mobile trichomonads in direct examination with saline or culture Positive to T. vaginalis or Polymerase Chain Reaction Test (PCR) positive for T. vaginalis in the 5 days prior to inclusion in the study. • Written informed consent of the patient or her legal representative. • Patients of reproductive age must also have a pregnancy test in negative urine in the 48 hours prior to the start of the clinical study.
Exclusion criteria
Exclusion criteria: • Diagnosis of Vulvovaginal Candidiasis by identification of pseudohyphae in the direct examination. • Diagnosis of Bacterial Vaginosis by observation of clue cells in the direct examination. • Having received a derivative of S-nitroimidazoIe (metronidazole, tinidazole, ornidazole or secnidazole) or treatment with nitazoxanide in a period of 14 days prior to randomization. • History of hypersensitivity to nitazoxanide or metronidazole. • Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:• Complete physical examination. • Evaluation of symptoms. • Evaluation of adverse experiences. • Record sexual contacts. • Gynecological examination. • Fresh sample taken to identify T. vaginalis according to the same procedure that the pre-enrollment visit • Sample taking for T. vaginalis culture and evaluation by PCR. Measure:Efficacy of Nitazoxanide in a single dose of 3g VO and metronidazole in a single dose of 2g in the eradication of T. vaginalis. Timepoints:from day 7 to day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:• vulvovaginal irritation • Abnormal vaginal odor • Abnormal vaginal discharge • vulvovaginal itching • Dysuria • Dyspareunia. Measure:Evaluation of symptoms: it will be done according to the method described in the study by Du Bouchet et al. Timepoints:from day 7 to day 10 | — |
Countries
Peru
Outcome results
None listed