Phase
Condition
Bronchitis
Ear Infections (Pediatric)
Respiratory Syncytial Virus (Rsv) Infection
Treatment
N/AClinical Study ID
Ages 2-12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 bacterialbronchitis requiring antibiotic treatment.
Exclusion
Exclusion Criteria:
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 (forsafety reasons).
Known to or suspected of not being able to comply with the study protocol and the useof clarithromycin.
Requirement for, or current use of, systemic antibacterial agents not specified in theprotocol.
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 thenose and throat.
History or presence of disease or concomitant medication contraindicating the use ofclarithromycin.
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.
Study Design
Study Description
Connect with a study center
DE11
Balve, 58802
GermanySite Not Available
DE10
Beckum, 59269
GermanySite Not Available
DE09
Hameln, 31785
GermanySite Not Available
DE08
Hannover, 30625
GermanySite Not Available
DE12
Künzing, 94550
GermanySite Not Available
DE02
München, 81675
GermanySite Not Available
DE03
München, 81669
GermanySite Not Available
DE05
München, 81241
GermanySite Not Available
DE06
München, 81543
GermanySite Not Available
DE13
München, 81739
GermanySite Not Available
DE14
München, 80393
GermanySite Not Available
DE04
Olching, 82140
GermanySite Not Available
DE07
Pullach im Isartal, 82049
GermanySite Not Available
DE01
Unterhaching, 82008
GermanySite Not Available
PL03
Kozieglowy,
PolandSite Not Available
PL06
Kraków,
PolandSite Not Available
PL01
Lódz,
PolandSite Not Available
PL04
Otwock,
PolandSite Not Available
PL05
Warszawa,
PolandSite Not Available
PL02
Wroclaw,
PolandSite Not Available
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