Pharyngitis, Pharyngotonsillitis or Sinusitis MedDRA version: 9.1 Level: LLT Classification code 10057868 Term: Upper respiratory tract infection bacterial
Conditions
Interventions
Trade Name: PANACEF*GRATxSOSP 250MG/5ML
Pharmaceutical Form: Granules for oral suspension
INN or Proposed INN: Cefaclor
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concen
Sponsors
VALEAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: For both pathologies: Patients with hypersensitivity established with beta-lactamase; Patients treated with antibiotics in the preceding 10 days; patients suffering from renal, hepatic, hematologic and neoplastic pathologies, patients with immune system disorders and undergoing immunosuppressive therapy; patients with gastrointestinal conditions that could influence absorption; patients with mononucleosis. For the sinusitis pathology only: Patients suffering from chronic bacteric sinusitis resistant to antibiotic therapy. Patients who have undergone surgery of the paranasal sinus; patients with nasal polyposis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Tolerability evaluation (minor adverse drug reactions during the first 3 days of treatment with cefaclor in comparison to amoxicilline-clavulanate);Secondary Objective: Palatability evaluation; tolerability evaluation also during the remaining period of treatment; clinical and bacteriologic response to the treatment;Primary end point(s): Tolerability evaluation (minor adverse drug reactions during the first 3 days of treatment with cefaclor in comparison to amoxicilline-clavulanate) | — |
Countries
Italy
Outcome results
None listed