Last updated: 11/07/2018 13:27:52
A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Oral Augmentin SR 2000/125mg Twice Daily Versus Oral Augmentin 875/125mg Twice Daily for 7 days in the Treatment of Adults with Bacterial Community Acquired Pneumonia.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Oral Augmentin SR 2000/125mg Twice Daily Versus Oral Augmentin 875/125mg Twice Daily for 7 days in the Treatment of Adults with Bacterial Community Acquired Pneumonia.
Trial description: A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Oral Augmentin SR 2000/125mg Twice Daily Versus Oral Augmentin 875/125mg Twice Daily for 7 days in the Treatment of Adults with Bacterial Community Acquired Pneumonia.
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:
File T, Garau J, Jacobs MR, Wynne B. Pharmacokinetically enhanced amoxicillin/clavulanate 2000/125 mg in the treatment of community-acquired pneumonia (CAP) caused by Streptococcus pneumoniae, including penicillin-resistant strains. Abstracts from the 41st Annual Meeting of the Infectious Disease Society of America, San Francisco, USA. October 2003, page 84, Abstract 303.
File T, Garau J, Jacobs MR, Wynne B. Pharmacokinetically enhanced amoxicillin/clavulanate 2000/125 mg in the treatment of community-acquired pneumonia (CAP) caused by Streptococcus pneumoniae, including penicillin-resistant strains. Int J Antimicrob Agents 2005; 25(2):110–119.
File T, Lode H, Kurz H, Crann R and The 600 Study Group. Comparative efficacy/safety of pharmacokinetically enhanced amoxicillin/clavulanate 2000/125 mg vs amoxicillin/clavulanate 875/125 mg in community-acquired pneumonia (CAP). Abstracts from the 99th Annual Meeting of the American Thoracic Society, Seattle, USA. May 2003, page A370, Abstract B37.
File TM Jr, Lode H, Kurz H, Kozak R, Xie H, Berkowitz E. Double-blind, randomized study of the efficacy and safety of oral pharmacokinetically enhanced amoxicillin-clavulanate (2000/125 milligrams) versus those of amoxicillin-clavulanate (875/125 milligrams), both given twice daily for 7 days, in treatment of bacterial community-acquired pneumonia in adults. Antimicrob Agents Chemother 2004;48:3323–3331.
Garau J, Jacobs MR, Wynne B, Berkowitz E, Twynholm M. Pharmacokinetically enhanced amoxicillin/clavulanate (AMX/CA) 2000/125 mg in the treatment of community-acquired pneumonia (CAP) and acute bacterial sinusitis (ABS) caused by Streptococcus pneumoniae. Abstracts from the 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy. Chicago, USA. September 2003, page 422, Abstract L-1382.
S. Miller, M. Twynholm, E. Berkowitz, S. Gormley, A. White, L.A. Miller, C. Jakielaszek. Bacteriological outcomes with pharmacokinetically enhanced amoxicillin/clavulanate (2000/125 mg) in patients with community-acquired respiratory infection caused by Streptococcus pneumoniae, including drug-resistant (DRSP) strains. Abstracts from the 15th European Congress of Clinical Microbiology and Infectious Diseases, April 2005.
Medical condition
Pneumonia, Community-Acquired
Product
amoxicillin/clavulanic acid
Collaborators
Not applicable
Study date(s)
January 2001 to March 2002
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
Clinical study report
Available language(s): English
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
2002-11-03
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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