Surveillance Study Finds Newly-Approved Antibiotic KETEK(R) (telithromycin) Tablets 99% Effective In Vitro Against Streptococcus
23 Maio 2004 - 2:15PM
PR Newswire (US)
Surveillance Study Finds Newly-Approved Antibiotic KETEK(R)
(telithromycin) Tablets 99% Effective In Vitro Against
Streptococcus pneumoniae Bacteria - Multi-drug resistance common
among isolates of Streptococcus pneumoniae in the United States -
ORLANDO, Fla., May 23 /PRNewswire-FirstCall/ -- Results from an
ongoing surveillance study, PROTEKT US (Prospective Resistant
Organism Tracking and Epidemiology of the Ketolide Telithromycin -
United States) Year 2 (2001- 2002), suggest that KETEK(R)
(telithromycin) is highly active in vitro against Streptococcus
pneumoniae (S. pneumoniae) isolates, including those resistant to
other antimicrobial agents. These data were presented today at the
100th International Conference of the American Thoracic Society
(ATS). Increasing multi-drug resistance among S. pneumoniae
isolates compromises the treatment of community-acquired
respiratory tract infections. This study found that nearly 30%
(n=2,805) of S. pneumoniae isolates were resistant to several
antibacterials, including penicillin, cefuroxime, erythromycin,
clindamycin, levofloxacin, tetracycline and co-trimoxazole, while
more than 99% (n=9,517) of S. pneumoniae isolates were susceptible
to KETEK, irrespective of multi-drug resistance. A total of 242
centers submitted 9,531 S. pneumoniae isolates for the study. "The
increasing incidence of multi-drug resistant S. pneumoniae poses a
challenge in the management of community-acquired respiratory tract
infections," said Steven Brown, PhD, of the Clinical Microbiology
Institute, Wilsonville, Oregon and the lead author of the poster.
"As results from PROTEKT US demonstrate, KETEK is active against
these resistant strains of S. pneumoniae in vitro." About the Study
Data from PROTEKT US were analyzed to determine the prevalence of
multi- drug resistance (defined as resistant to > or equal to 2
antimicrobials) among S. pneumoniae isolates. A total of 9,531 S.
pneumoniae isolates from bronchoalveolar lavage, blood, ear,
nasopharyngeal swab/aspirate, sinus and sputum cultures were
examined from patients in 242 centers across the United States.
Isolates were studied for in vitro resistance to penicillin,
cefuroxime, erythromycin, clindamycin, levofloxacin, tetracycline
and co-trimoxazole. Study results found that 2,805 of the S.
pneumoniae isolates were multi-drug resistant. Resistance to four
antibacterials was the most common type of multi-drug resistance in
all culture sources. The most common example of multi-drug
resistance was resistance to penicillin, cefuroxime, erythromycin
and co- trimoxazole, accounting for 74.6% of four antimicrobial
resistance from bronchoalveolar lavage cultures, 85.9% from blood
cultures, 73.4% from ear cultures, 76.0% from nasopharyngeal
swab/aspirate cultures, 73.8% from sinus cultures and 69.1% from
sputum cultures. Overall, 99.9% of the S. pneumoniae isolates were
susceptible to KETEK, ranging from 99.4% (bronchoalveolar lavage
cultures) to 99.9% (blood and sputum). About Streptococcus
pneumoniae The pathogen S. pneumoniae, which accounts for more than
4 million deaths annually, is recognized as the most important
pathogen of the respiratory tract in adults and is identified as
the most common etiologic agent in community-acquired pneumonia
(CAP) and acute bacterial sinusitis. Additionally, it is the
pathogen most associated with morbidity and mortality and is
identified in virtually all CAP studies, causing approximately two
thirds of all cases of bacteremic pneumonia. Resistance to
established antibiotics continues to grow, with penicillin and
macrolide resistance rates for S. pneumoniae reported at 39% and
31%, respectively. About PROTEKT PROTEKT US is one of the largest
surveillance studies in the United States, evaluating in its first
year more than 17,000 pathogens in more than 206 sites across 44
states. The study was initiated in 2000 and was designed to monitor
the spread of resistant phenotypes and genotypes of the major
respiratory tract infection pathogens across the nation. It is an
ongoing study that is a branch of a larger international study
called PROTEKT, which altogether includes more than 500 centers in
35 countries worldwide. About KETEK(R) KETEK was recently approved
by the U.S. Food and Drug Administration to treat
community-acquired respiratory tract infections in patients age 18
and older with acute bacterial exacerbation of chronic bronchitis;
acute bacterial sinusitis; and mild to moderate community-acquired
pneumonia, including those infections caused by multi-drug
resistant Streptococcus pneumoniae (MDRSP). In clinical trials, the
most commonly reported side effects were nausea, headache,
dizziness, vomiting, and diarrhea. About Aventis Aventis is
dedicated to treating and preventing disease by discovering and
developing innovative prescription drugs and human vaccines. In
2003, Aventis generated sales of 16.79 billion euros (US $18.99),
invested 2.86 billion euros (US $3.24) in research and development
and employed approximately 69,000 people in its core business.
Aventis corporate headquarters are in Strasbourg, France. The
company's prescription drugs business is conducted in the U.S. by
Aventis Pharmaceuticals Inc., which is headquartered in
Bridgewater, New Jersey. For more information, please visit:
http://www.aventis-us.com/. Statements in this news release
containing projections or estimates of revenues, income, earnings
per share, capital expenditures, capital structure, or other
financial items; plans and objectives relating to future
operations, products, or services; future economic performance; or
assumptions underlying or relating to any such statements, are
forward-looking statements subject to risks and uncertainties.
Actual results could differ materially depending on factors such as
the timing and effects of regulatory actions, the results of
clinical trials, the company's relative success developing and
gaining market acceptance for new products, the outcome of
significant litigation, and the effectiveness of patent protection.
Additional information regarding risks and uncertainties is set
forth in the current Annual Report on Form 20-F of Aventis on file
with the Securities and Exchange Commission and in the current
Annual Report -- "Document de Reference" -- on file with the
"Autorite des marches financiers" in France. DATASOURCE: Aventis
CONTACT: Lise Geduldig, +1-908-243-6580, , or Melissa Feltmann,
+1-908-243-7080, , both of Aventis US Product Communications Web
site: http://www.aventis-us.com/
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