Last updated: 11/07/2018 13:27:42
An Open, Non-Comparative Multicenter Study to Assess the Efficacy and Safety of Oral AUGMENTIN SR 2000/125mg Twice Daily for 10 Days in the Treatment of Acute Bacterial Sinusitis 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: An Open, Non-Comparative Multicenter Study to Assess the Efficacy and Safety of Oral AUGMENTIN SR 2000/125mg Twice Daily for 10 Days in the Treatment of Acute Bacterial Sinusitis in Adults.
Trial description: An Open, Non-Comparative Multicenter Study to Assess the Efficacy and Safety of Oral AUGMENTIN SR 2000/125mg Twice Daily for 10 Days in the Treatment of Acute Bacterial Sinusitis 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:
Anon J, Ferguson B, Wynne B, Kozak R and the 592 Clinical Study Group. Pharmacokinetically enhanced amoxicillin/clavulanate 2000/125 mg twice daily in the treatment of acute bacterial sinusitis (ABS) in adults. Abstracts from the 41st Annual Meeting of the Infectious Disease Society of America, San Francisco, USA. October 2003, page 84, Abstract 300
Anon JB, Berkowitz E, Breton J and Twynholm M. Efficacy and Safety of Pharmacokinetically Enhanced Amoxicillin/Clavulanate 2000/125 mg in Adult Patients With Acute Bacterial Sinusitis. Abstracts from the 42nd Annual Meeting of the Infectious Diseases Society of America, Boston, USA. September 2004, Abstract P414.
Efficacy and safety of pharmacokinetically enhanced amoxicillin/clavulanate 2000/125 mg in adult patients with acute bacterial sinusitis in Hungary, Tamas, L.; Kovacs, P.; Horvai, G.; Twynholm, M. Budapest, HUN; Harlow, UK; Prague; Czech Republic. 14th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). 5/1/2004
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. 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
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): 235–47.
Garau J, File T, Jacobs MR, Poole MD, Wynne B, The 546–551, 566, 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.
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. Abstract Accepted, Augmentin 1 g/125 mg 2 times a day in acute maxillary sinusitis: augmentin 1 g/125 mg 2 fois par jour dans les sinusites maxillaires aigues. Gehanno, P. Presse Med 2000; 29(26 Suppl):15-7
Medical condition
Sinusitis
Product
amoxicillin/clavulanic acid
Collaborators
Not applicable
Study date(s)
November 2000 to July 2003
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
2003-23-07
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website