Status:
COMPLETED
Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections
Lead Sponsor:
Grünenthal GmbH
Conditions:
Otitis Media
Tonsillitis
Eligibility:
All Genders
2-12 years
Phase:
PHASE3
Brief Summary
This study was performed in children with upper respiratory tract infections (acute ear infection, infection of the tonsils or throat, or bacterial inflammation of the bronchi) who needed treatment wi...
Detailed Description
The study population were children aged 2-12 years (weight 12-40 kg) suffering from upper respiratory tract infections (acute otitis media, tonsillitis, pharyngitis, or acute bacterial bronchitis) and...
Eligibility Criteria
Inclusion
- Male and female children weighing 12-40 kg.
- Age 2 -12 years.
- Written informed consent (parents).
- Diagnosis of acute otitis media, tonsillitis, pharyngitis, or acute bacterial bronchitis requiring antibiotic treatment.
Exclusion
- Participation in another study of investigational products or of devices parallel to, or less than 4 weeks before study entry, or previous participation in this study (for safety reasons).
- Known to or suspected of not being able to comply with the study protocol and the use of clarithromycin.
- Requirement for, or current use of, systemic antibacterial agents not specified in the protocol.
- Necessity of dose reduction due to any concomitant disease.
- Known human immunodeficiency virus (HIV) positive.
- Other inflammatory/infectious diseases of the ear, the upper respiratory tract or the nose and throat.
- History or presence of disease or concomitant medication contraindicating the use of clarithromycin.
- Known or suspected intolerance / hypersensitivity to macrolides.
- Contraindications according to the clarithromycin Summary of Product Characteristics (SmPC).
- Indication for antibiotic treatment for less than 7 days or more than 10 days.
- If known before entry, bacterial isolate resistant to clarithromycin.
Key Trial Info
Start Date :
September 22 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2004
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT04016051
Start Date
September 22 2004
End Date
December 23 2004
Last Update
July 11 2019
Active Locations (20)
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1
DE11
Balve, Germany, 58802
2
DE10
Beckum, Germany, 59269
3
DE09
Hamelin, Germany, 31785
4
DE08
Hanover, Germany, 30625