Pneumonia, Bacterial Clinical Trial
Official title:
Randomized Aseptic Pharmacokinetic Pharmacodynamic Outpatient Registry Trial of Respiratory Tract Infections in Adults (RAPPORT)
Verified date | July 2015 |
Source | CPL Associates |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To measure the speed of bacterial eradication from the respiratory tract after administration of azithromycin or telithromycin.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Western Kentucky Pulmonary Clinic | Louisville | Kentucky |
United States | Northshore Research Associates | Slidell | Louisiana |
Lead Sponsor | Collaborator |
---|---|
CPL Associates | Sanofi |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to bacterial eradication | 11-18 days | ||
Primary | Bacteriologic outcome | 11-18 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03303976 -
Phase I to Test a New Pneumococcal Vaccine
|
Phase 1 | |
Completed |
NCT02459158 -
A Study to Assess the Pharmacokinetic Profile, the Safety, and the Tolerability of ME1100 Inhalation Solution in Patients With Mechanically Ventilated Bacterial Pneumonia
|
Phase 1 | |
Completed |
NCT06113432 -
CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: Cross-over Study
|
N/A | |
Active, not recruiting |
NCT03577964 -
Development of Pneumonia Due to Alveolar Glucose Levels in Systemic Hyperglycemia
|
||
Completed |
NCT04540081 -
Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer
|
N/A | |
Completed |
NCT00538694 -
Comparative Study of Cidecin™ (Daptomycin) to Rocephin® (Ceftriaxone) in the Treatment of Moderate to Severe Community-Acquired Acute Bacterial Pneumonia
|
Phase 3 | |
Withdrawn |
NCT02218359 -
Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative and / or Gram-positive Bacterial Colonization
|
Phase 2 | |
Completed |
NCT01189487 -
The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
|
Phase 3 | |
Completed |
NCT00515034 -
A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia
|
Phase 2 | |
Completed |
NCT03239665 -
Vaccination Education Through Pharmacists and Senior Centers (VEPSC)
|
N/A | |
Completed |
NCT03034642 -
Modulation of Steroid Immunosuppression by Alveolar Efferocytosis
|
N/A | |
Completed |
NCT04047719 -
Pneumonia in the ImmunoCompromised - Use of the Karius Test for the Detection of Undiagnosed Pathogens
|
||
Completed |
NCT02292498 -
Thermal Imaging to Diagnose and Monitor Suspected Bacterial Infections
|
N/A | |
Completed |
NCT01763008 -
A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections
|
Phase 4 | |
Recruiting |
NCT05976581 -
Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients
|
N/A | |
Completed |
NCT03551210 -
Efficacy and Safety of Nemonoxacin vs Levofloxacin in Adult Patients With Community-Acquired Pneumonia
|
Phase 3 | |
Completed |
NCT04158804 -
PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs (ProSAVE): A RCT
|
N/A | |
Completed |
NCT00805168 -
Inhaled Amikacin Solution (BAY 41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
|
Phase 3 | |
Completed |
NCT02778672 -
Thermal Imaging of the Lung on a Smartphone to Differentiate Bacterial From Non Bacterial Causes of Pneumonia
|
N/A | |
Completed |
NCT00724828 -
Study Evaluating Streptococcus Pneumoniae Serotype Carriage Rate for Nasopharyngeal Carriage in Filipino Children
|
N/A |