Comparative study in pharyngitis and / or acute tonsillitis of Cephalexin (Keflex) versus Amoxicilli

Not Applicable

• Conditions: -J029 Acute pharyngitis, unspecified-J039 Acute tonsillitis, unspecified; Acute pharyngitis, unspecified; Acute tonsillitis, unspecified; J029; J039

• Registration Number: PER-002-00
• Lead Sponsor: ELI LILLY INTERAMERICA INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-01-21
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

Inclusion Criteria

Patients from 2 years to 12 years of age.
Diagnosis of acute pharyngitis or acute tonsillitis (<7 days duration)
Rapid Stret positive test before starting treatment.
The parent or legal representative must sign an informed consent document approved by a CE (Ethics Committee).
The investigator will try to select those patients with a history of complying with the instructions received.

Exclusion Criteria

Patients whose symptoms are due to evident viral infection of the upper respiratory tract.
Researchers and their immediate family members are not allowed to be subjects or patients in studies sponsored by Lilly. As an immediate family member, the researcher´s spouse, parents, children, grandparents or grandchildren are defined.
People who have previously completed this study or have withdrawn from it will not be eligible to participate in this study.
Reaction of severe hypersensitivity prior to cephalosporins or penicillin.
Administration of systemic antibiotics in the 7 days prior to randomization.
Inability to go to valuation consultation.
Concomitant use of probenecid or concomitant treatment with corticosteroids.
History of significant renal deterioration.
Any condition that, in the opinion of the investigator, could impede the evaluation of the response.
Patients who have received an agent in research (a drug that has not been approved for sale in the countries in which this study is conducted) as participants in a study, in the last 30 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:The symptomatic response will be evaluated during treatment and in post-treatment evaluations, and documented in the form for clinical reporting. The symptomatic response will be based on the definitions presented below.<br>Healing: Elimination of the signs and symptoms of infection without recurrence in the follow-up period, in relation to the initial symptomatic condition of the patient.<br>Improvement: Significant, although incomplete, resolution of the signs and symptoms of infection.<br>Patients with cultures positive for Streptococcus beta<br>Hemolytic group A (GABHS) among other germs sensitive to cephalexin or amoxicillin will be evaluated in terms of their bacteriological response to treatment.<br>Measure:Efficacy<br>Timepoints:During treatment and follow up<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:During the first evaluation, the staff of the research center will question each patient or parent / guardian and note the occurrence and nature of the condition (s) of presentation and any pre-existing condition (s). During subsequent evaluations, staff at the research center will cross-examine the patient or parent / guardian and note any change in the presentation (s), any change in the pre-existing condition (s). {s), and / or the appearance and nature of any adverse event that may arise.<br>Measure:Safety<br>Timepoints:During the treatment<br>