Last updated: 11/07/2018 13:27:19
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 Three Times Daily for 7 or 10 Days for the Treatment of Bacterial Community Acquired Pneumonia in Adults.
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 Three Times Daily for 7 or 10 Days for the Treatment of Bacterial Community Acquired Pneumonia in Adults.
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 Three Times Daily for 7 or 10 Days for the Treatment of Bacterial Community Acquired Pneumonia in Adults.
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:
Bactericidal activity of 2000/125mg sustained-release versus 875/125 mg amoxicillin/clavulanic acid against S. pneumoniae: an amoxi- cillin in vitro pharmacodynamic simulation, Sevillano, D; Calvo, A; Aguilar, L; Alou, L; Giménez, MJ; Valero, E; Prieto, J. Microbiology Department, School of Medicine, Universidad Complutense de Madrid, Madrid, Spain; Paris; France. 6th European Congress of Chemotherapy and Infection and 24th Interdisciplinary Meeting on Chemotherapy and Infection. 12/1/2004
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):110119.
File T, Jacobs MR, Poole MD, Wynne B. Clinical efficacy of pharmacokinetically enhanced amoxicillin/clavulanate (AMX/CA) vs comparators against Streptococcus pneumoniae (Sp) in respiratory tract infections (RTIs). Abstracts from the 2nd Forum on Respiratory Tract Infections, Monte Carlo, Monaco. February 2002, page 62, Abstract P4.
File T, Jacobs MR, Poole MD, Wynne B. Outcome of treatment of respiratory tract infections due to Streptococcus pneumoniae, including drug-resistant strains, with pharmacokinetically enhanced amoxycillin/clavulanate. Int J Antimicrob Agents 2002; 20(4): 23547.
File T, Jacobs MR, Poole MD, Wynne B. Pharmacokinetically enhanced amoxicillin/clavulanate against Streptococcus pneumoniae (Sp) in respiratory tract infections (RTIs). Abstracts from the 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, USA. September 2002, page 359, Abstract L-990.
Garau J, File T, Jacobs MR, Poole MD, Wynne B, The 546551, 556, 557 and 592 Clinical Study Groups. Efficacy of amoxicillin/clavulanate (AMX/CA) 2000/125 mg b.i.d. against Streptococcus pneumoniae non-susceptible to AMX. Abstracts from the 4th International Meeting on the Therapy of Infections, Florence, Italy. October 2002, page 71, Abstract A5.
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.
Garau J, Twynholm M, Garcia-Mendez E, Siquier B, Rivero A and the 557 Clinical Study Group. Oral pharmacokinetically enhanced co-amoxiclav 2000/125 mg, twice daily, compared with co-amoxiclav 875/125 mg, three times daily, in the treatment of community-acquired pneumonia in European adults. J Antimicrob Chemother 2003; 52(5): 82636.
Garau J, Twynholm M, Garcia-Mendez E. Comparative efficacy and safety of pharmacokinetically enhanced amoxicillin/clavulanate b.d. versus amoxicillin/clavulanate 875/125 mg t.d.s. in community-acquired pneumonia (CAP). Abstracts from the 12th European Congress of Clinical Microbiology and Infectious Diseases. Clin Microbiol Infect 2002; 8 (Suppl 1): 322. Abstract P1374
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 2000 to January 2001
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
2001-02-01
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
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