Acute pharyngotonsillitis MedDRA version: 6.1 Level: PT Classification code 10062352
Conditions
Interventions
Trade Name: PANACEF*GRATxSOSP 250MG/5ML
Product Name: cefacloro
Pharmaceutical Form: Granules for oral suspension
INN or Proposed INN: Cefaclor
Current Sponsor code: MB 1206/1770/04
Concentration uni
Sponsors
VALEAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Clinical diagnosis of pharyngotonsillitis in male or female Patients aged 3 to 12 years Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients affected by liver, kidney, hematologic or neoplastic diseases. Patients with gastrointestinal disorders. Patients with immunological disorders. Patients with hypersensitivity to beta-lactame. Concomitant use of immuno active or antibiotic drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study the ''in vivo'' effects of Cefaclor versus Amoxicillin on some functional parameters of the Immune System in paediatric patients in order to evaluate the use in Clinical practice concerning the interactions on the immune system;Secondary Objective: Correlate the Clinical efficacy (clinical judgement and bacterial eradication) with the effects on the functional parameters of the immune system;Primary end point(s): Study the ''in vivo'' effects of Cefaclor versus Amoxicillin on some functional parameters of the Immune System in paediatric patients in order to evaluate the use in Clinical practice concerning the interactions on the immune system | — |
Countries
Italy
Outcome results
None listed