Outpatient Registry Trial of Respiratory Tract Infections in Adults

Condition(s) targeted: Pneumonia, Bacterial; Bronchitis, Chronic

Intervention: azithromycin (Drug); telithromycin (Drug); Clarythromycin (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: CPL Associates

Official(s) and/or principal investigator(s):
Jerome J Schentag, Pharm.D., Principal Investigator, Affiliation: State University of New York at Buffalo
Joseph Paladino, Pharm.D., Study Director, Affiliation: State University of New York at Buffalo

To measure the speed of bacterial eradication from the respiratory tract after administration of azithromycin or telithromycin.

Official title: Randomized Aseptic Pharmacokinetic Pharmacodynamic Outpatient Registry Trial of Respiratory Tract Infections in Adults (RAPPORT)

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study

Primary outcome:

Time to bacterial eradication

Bacteriologic outcome

Detailed description: 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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Western Kentucky Pulmonary Clinic, Louisville, Kentucky 42240, United States

Northshore Research Associates, Slidell, Louisiana 70461, United States

Starting date: October 2005
Ending date: July 2006
Last updated: October 30, 2007