EUCTR2005-004363-34-IT
Active, not recruiting
Not Applicable
Antibiotic therapy in children for the upper respiratory tract infections. Study of the ''tollerability profile'' of cefaclor and amoxicillin-clavulanate - Clinical Trial FIMP
VALEAS0 sitesDecember 11, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pharyngitis, Pharyngotonsillitis or Sinusitis
- Sponsor
- VALEAS
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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