Last updated: 11/07/2018 13:25:02
An Open-Label Study to Demonstrate Bacteriological Efficacy of Augmentin ES in the Treatment of Acute Otitis Media Due to S. pneumoniae.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An Open-Label Study to Demonstrate Bacteriological Efficacy of Augmentin ES in the Treatment of Acute Otitis Media Due to S. pneumoniae.
Trial description: An Open-Label Study to Demonstrate Bacteriological Efficacy of Augmentin ES in the Treatment of Acute Otitis Media Due to S. pneumoniae.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Dagan R, Hoberman A, Johnson C, Leibovitz EL, Arguedas A, Rose FV, Wynne BR, Jacobs MR. Bacteriologic and clinical efficacy of high dose amoxicillin/clavulanate in children with acute otitis media. Pediatr Infect Dis J 2001; 20(9): 829–837.
Dagan R, Hoberman A, Leibovitz E, Arguedas A, Wynne B, Rose FV, Jacobs M. Bacteriological and clinical efficacy of a new amoxicillin/clavulanate extra-strength formulation (A/C 14:1) in the treatment of acute otitis media. Abstracts from the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy 2000; Abstract 107, p 491.
Medical condition
Otitis Maedia
Product
amoxicillin/clavulanic acid
Collaborators
Not applicable
Study date(s)
February 1999 to June 2000
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2000-12-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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