NCT00245453撤回4 期
Randomized Aseptic Pharmacokinetic Pharmacodynamic Outpatient Registry Trial of Respiratory Tract Infections in Adults (RAPPORT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Time to bacterial eradication
研究概览
简要总结
To measure the speed of bacterial eradication from the respiratory tract after administration of azithromycin or telithromycin.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
1 Azithromycin
Active Comparator
干预措施: azithromycin (Drug)
2 Clarythromycin
Active Comparator
干预措施: Clarythromycin (Drug)
3 Telithromycin
Active Comparator
干预措施: telithromycin (Drug)
结局指标
主要结局
Time to bacterial eradication
时间窗: 11-18 days
Bacteriologic outcome
时间窗: 11-18 days
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean DeliveryEndometritisNCT01464840University of Alabama at Birmingham30
已完成
2 期
A Study To Measure The Level Of Drug In Nasal Tissue And Blood After Taking A Single 2g Dose Or 500mg Tablets For Up ToSinusitisNCT00232154Pfizer72
已完成
4 期
Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled TrialPreterm Premature Rupture of MembraneNCT04294069Thomas Jefferson University6
已完成
2 期
A Study of Standard Drugs for Mycobacterium Avium ComplexMycobacterium Avium ComplexNCT04287049Johns Hopkins University10
已完成
1 期
A Single-Dose, Three-Way, Three-Sequence, Crossover BA Study of Azithromycin OleogelInfectious DiseaseDrug EffectClinical InfectionNCT05796362Brigham and Women's Hospital18