None listed
Conditions
Interventions
Days 1-5: .1 capsule with 1 tablet of 400 mg of Moxifloxacin active orally in the morning + 1 capsule of identical placebo orally in the afternoon.
Days 6-10: 1 capsule of identical placebo orally in the morning + 1 capsule of identical placebo orally in the afternoon
Group name:Group II Type of group
Days 1-10 1 capsule with 1 tablet of 250 mg of Clarithromycin oral in the morning + 1 capsule with 1 tablet of 250 mg oral Clarithromycin in the afternoon
Sponsors
BAYER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Ambulatory patients of both sexes of at least 18 years old. • Patients with a clinical diagnosis of strep throat / streptococcal tonsillitis suspected as evidenced by: • Absence of symptoms that suggest a viral infection • Patients with a rapid positive antigen detection test for p-hemolytic Streptococcus Group A. • Patients who have been taken a sample suitable for culture from smears of the anterior pharynx and tonsillar columns prior to the start of treatment. • Written informed consent signed by the patient prior to the recruitment has been received.
Exclusion criteria
Exclusion criteria: • Female patients who are pregnant, breast-feeding or using an inadequate method of contraception. Pregnancy should be ruled out by rapid urinary pregnancy test during the evaluation stage in all women of childbearing age, regardless of the method of contraception used. • Patients known to be carriers of Streptococcus pyogenes. • Patients with complications of pharyngitis or pharyngotonsillitis such as peri-tonsillar abscess, otitis media, meningitis, etc. • Patients who require antibiotic therapy for other reasons. • Patients who have received systemic antimicrobial therapy for more than 24 hours within two weeks prior to recruitment. • Patients with a previous history of seizures, severe injury from head trauma, or within 2 months after a stroke event. • Patients diagnosed with an underlying disease of rapid fatal course (death expected within 2 months). • Patients with severe hepatic impairment (Child-Pngh C) • Patients with severe renal insufficiency (plasma creatinine> 3.0 mg / dl. • Patients known or suspected to have severe neutropenia (absolute neutrophil count 15 mg / day of systemic prednisolone or equivalent). • Patients previously recruited in this study. • Patients who have participated in other clinical work within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Culture of the posterior pharynx Measure:Moxifloxacin microbiological eradication rate Timepoints:First day of treatment and 8 and 35 days after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical examination and clinical response evaluation Measure:Clinical Response to both medications Timepoints:On days 3 to 5 of treatment and days 4 to 8 after the end of treatment ; Outcome name:Clinical examination, clinical response evaluation and Culture of the posterior pharynx Measure:General correlation between clinical cure and bacterial eradication Timepoints:On days 3 to 5 of treatment and days 4 to 8 after the end of treatment ; Outcome name:Clinical evaluation and evaluation of clinical response Measure:Recurrence frequency or carrier status of S. pyogenes Timepoints:at 28 to 35 days after the end of treatment. ; Outcome name:Physical examination, blood chemistry and liver tests, Hematology Measure:Development of sequelae to infection such as nephritis or carditis Timepoints:at 28 to 35 days after the end of treatment. ; Outcome name:Physical examination, blood chemistry and liver tests, Hematology Measure:Safety and Tolerability Timepoints:at 28 to 35 days after the end of treatment. | — |
Outcome results
None listed