None listed
Conditions
Interventions
Cefalexin (Keflex) will be 50 mg / kg / day twice daily for 10 days
Group name:Cefadroxil Type of group
Cefadroxil 30 mg / kg / day twice a day for 10 days.
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: • Patients from 2 years to 12 years of age. • Diagnosis of acute pharyngitis or acute tonsillitis (<7 days duration) • Rapid Strep positive test before starting treatment. • The parent or legal representative must sign an informed consent document approved by a CE (Ethics Committee). • The researcher will try to select those patients with a history of complying with the instructions received.
Exclusion criteria
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. • Persons who have previously completed this study or withdrawn from it will not be eligible to participate in this study.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 assessment 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name: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. Improvement: Significant, although incomplete, resolution of the signs and symptoms of infection. Failure (applies only to a Post-treatment Evaluation): Signs and symptoms have not been alleviated or improved with treatment. Indefinite: Inability to evaluate a symptomatic response Relapse: There is no improvement or there is worsening of the signs and symptoms of infection after a symptomatic cure response or improvement in post-treatment evaluations. Measure:Sintomatic Response Timepoints:The symptomatic response will be evaluated during treatment and in post-treatment evaluations. ; Outcome name:Indefinite: Inability to evaluate Eradication: Group A beta hemolytic Streptococcus (EBHGA) was eliminated Alleged eradication: It implies that obtaining culture was not clinically indicated. This requires a symptomatic response to cure or improvement. Persistence: 10 or more colony forming units of GABHS appear in the post-treatment culture. Recurrence: Absence of EBHGA in the post-treatment culture, although a minimum of 10 colony forming units are found in the Special Follow-up culture. Measure:Bacteriological Response Timepoints:After treatment | — |
Outcome results
None listed