EFFICACY AND SAFETY OF MOXIFLOXACIN 400 MG 1 TIME A DAY FOR 5 DAYS COMPARED WITH CLARITOMYCIN 250 MG 2 TIMES A DAY FOR 10 DAYS IN THE TREATMENT OF PHARINGO AMIGDALITIS IN ADULT PATIENTS CLINICAL STUDY PHASE III PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED IN PARALLEL GROUPS, MULTICENTRIC AND MULTINATIONA

Not Applicable

• Conditions: -J02-J039 Acute tonsillitis, unspecified; Acute tonsillitis, unspecified; J02; J039

• Registration Number: PER-071-00
• Lead Sponsor: BAYER S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-01-01
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

• 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 <1000 cells / mL).
• Patients in AIDS stage (guides when available: CD4 count <200
• cells / mm3) HIV positive patients may be included. HIV testing is not required for this study.
• Patients receiving antiretroviral therapy.
• Patients known to have congenital or sporadic QTc prolongation syndromes, or who are receiving concomitant medications that have been reported to increase the QTc interval, eg, amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine
• Patients with a history of allergy to fluoroquinolones, macrolides or related compounds.
• Patients with a history of tendinopathy secondary to fluoroquinolones.
• Patients with uncorrected hypokalemia.
• Patients with a history of rheumatic fever or glomerulonephritis.
• Patients with chronic treatment with a known immunosuppressive drug (including chronic treatment with> 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Culture of the posterior pharynx<br>Measure:Moxifloxacin microbiological eradication rate<br>Timepoints:First day of treatment and 8 and 35 days after treatment<br>