Antibiotic therapy in children for the upper respiratory tract infections. Study of the ''tollerability profile'' of cefaclor and amoxicillin-clavulanate - Clinical Trial FIMP

Conditions: Pharyngitis, Pharyngotonsillitis or Sinusitis
MedDRA version: 9.1Level: LLTClassification code 10057868Term: Upper respiratory tract infection bacterial

Registration Number: EUCTR2005-004363-34-IT

Lead Sponsor: VALEAS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Age <= 14 years; pharyngitis or pharyngotonsillitis (80% of the population to be enrolled) clinically diagnosed and confirmed by the rapid test for the determination of antigens for streptococcus A (SBEGA); sinusitis (20% of the population to be enrolled) clinically diagnosed with symptomatology (mucoid or purulent rhinorrhea, cough) lasted more than 10 days but less than 30 days and have not begun to improve (E.R. Wald, New England 3 Med., 326, 319,23 1992).
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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures