Outpatient Registry Trial of Respiratory Tract Infections in Adults

To Evaluate the relationship between rate of S. pneumoniae killing in sputum, PK/PD, and
clinical response of oral telithromycin and azithromycin in patients with AECB or CAP and to
determine if there is a difference in the rates of infection site bacterial killing (as
described above) between these 3 antibiotics against penicillin- and erythromycin-resistant
S.pneumoniae

Inclusion Criteria:

- Adult patients, either males or non-pregnant females, aged 18 to 75 years of age with
clinical findings of CAP or AECB who are amenable to serial nasopharyngeal and
oropharyngeal sampling and having positive Binax-NOW tests indicating infection with
Streptococcus pneumoniae

- Patients with a medical history and clinical findings consistent with a respiratory
tract infection. A patient with advanced COPD, repeated exacerbations by history, a
BINAX-NOW test consistent with S. pneumoniae and/or proven culture positivity for S.
pneumoniae may be enrolled

- All patients (CAP or AECB) must produce purulent sputum and be positive on the
Urinary BINAX-NOW assay.

- The female patient of child bearing potential must agree to use an accepted method of
contraception (i.e., oral or implanted contraceptive with a barrier method,
spermicide and barrier methods, or IUD). The patient must agree to continue with the
same method throughout the study.

Exclusion Criteria:

- Baseline sputum cultures known to be negative for S. pneumoniae, or negative urinary
BINAX-NOW.

- Patients with a microbiologically documented pathogen known prior to inclusion to be
resistant to any of the study medications.

- History of hypersensitivity to macrolides, azalides, ketolide antibiotics or history
of serious hypersensitivity reaction to any drug.

- Pre-existing impaired hepatic function or impaired renal function CCL <20ml/min

- Patients who will require on-study treatment with medications known to have
contraindicated drug interactions with telithromycin

- Treatment with more than one dose of an antimicrobial prior to entry into the study

Others as per protocol