Clinical trial NCT00245453: Outpatient Registry Trial of Respiratory Tract Infections in Adults
Official title: Randomized Aseptic Pharmacokinetic Pharmacodynamic Outpatient Registry Trial of Respiratory Tract Infections in Adults (RAPPORT)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pneumonia, Bacterial
Bronchitis, Chronic
Keywords: pneumonia
Spneumoniae
bronchitis
telithromycin
azithromycin
Lead sponsor: CPL Associates
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2005-10-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: Time to bacterial eradication
timeFrame: 11-18 days
measure: Bacteriologic outcome
timeFrame: 11-18 days
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Western Kentucky Pulmonary Clinic
state: Kentucky
city: Slidell
country: United States
facility: Northshore Research Associates
state: Louisiana
Study officials:
affiliation: State University of New York at Buffalo
name: Jerome J Schentag, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of New York at Buffalo
name: Joseph Paladino, Pharm.D.
role: STUDY_DIRECTOR
References: