Outpatient Registry Trial of Respiratory Tract Infections in Adults

CPL Associates

Status and phase: Withdrawn; Phase 4

Conditions: Bronchitis, Chronic; Pneumonia, Bacterial

Treatments: Drug: Clarythromycin; Drug: azithromycin; Drug: telithromycin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00245453

HMR3647A6004

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

1 Azithromycin

Active Comparator group

Treatment:

Drug: azithromycin

2 Clarythromycin

Active Comparator group

Treatment:

Drug: Clarythromycin

3 Telithromycin

Active Comparator group

Treatment:

Drug: telithromycin