Last updated: 11/07/2018 13:28:24
A Randomised Double Blind, Double-dummy Multicentre study to assess efficacy and safety of Oral Augmentin SR 2000/125mg bid versus oral Augmentin 875/125mg tid for 7 or 10 days for the treatment of CAP of suspected pneumococcal origin 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 study to assess efficacy and safety of Oral Augmentin SR 2000/125mg bid versus oral Augmentin 875/125mg tid for 7 or 10 days for the treatment of CAP of suspected pneumococcal origin in adults
Trial description: A Randomised Double Blind, Double-dummy Multicentre study to assess efficacy and safety of Oral Augmentin SR 2000/125mg bid versus oral Augmentin 875/125mg tid for 7 or 10 days for the treatment of CAP of suspected pneumococcal origin 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:
Pallars R, Siquier B, Palacios R, Snchez-Alvarez J, Sabri M, Garca-Mndez E, Kalia V, Twynholm M and the 620 Study Group. Pharmacokinetically Enhanced Amoxicillin/Clavulanate 2000/125 mg (PKE AMX/CA) vs AMX/CA 875/125 mg for Community-Acquired Pneumonia (CAP) in Spain. Abstracts from the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, USA. October 2004. Abstract L-911.
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 number P-1365.
Medical condition
Pneumonia, Community-Acquired
Product
amoxicillin, amoxicillin/clavulanic acid, clavulanic acid
Collaborators
Not applicable
Study date(s)
October 2001 to December 2003
Type
Not applicable
Phase
2/3
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
2003-16-12
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