EUCTR2006-002110-35-EE进行中（未招募）不适用
A Double-Blinded, Randomized, Parallel group, Multi-Centre, Multi-National Comparative Study of the Safety and Efficacy of Cethromycin 300mg QD to Clarithromycin (KLACID®) 250mg BID for the treatment of Community-Acquired Pneumonia in Adults
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Ambulatory male or female subjects 18 years of age or older.
- •2. A female must be non-lactating and at no risk for pregnancy for one of the
- •following reasons:
- •postmenopausal for at least 1 year, surgically sterile (hysterectomy) OR
- •if of child bearing potential, the subject must have a negative human
- •chorionic gonadotropin (HCG) pregnancy test and be utilizing a highly
- •effective method of birth control throughout the course of the study. (A
- •highly effective method of birth control is defined as one that results in a low
- •failure rate when used consistently and correctly, such as implants,
- •injectables, bilateral tubal ligation, combined oral contraceptives plus a
- •barrier method, some intrauterine devices, sexual abstinence, or a
- •vasectomized partner). If hormonal contraceptives are used, the specific
- •contraceptive must have been used for at least 2 months prior to screening. If
- •a subject is currently using an oral contraceptive the subject should also use
- •a barrier method (e.g., condom or diaphragm) during the study and for 1
- •month after study completion.
- •Subjects must not attempt to become pregnant during the study period.
- •(NOTE: All criteria are based on recommendations of the ICH Steering
- •Committee dated July 16, 1997)
- •3. Ambulatory male or female subjects 18 years of age or older. Subject must have a
- •chest X-ray consistent with a clinical diagnosis of bacterial pneumonia as
- •interpreted by the radiologist. If a previous radiograph (within 48 hours before
- •therapy) is available, the infiltrate must be a new one and there must have been no
- •intercurrent procedures or antimicrobial treatment.
- •(NOTE: Subjects may be enrolled based upon investigator assessment of X-ray,
- •but subsequent confirmation by a local board certified radiologist is required
- •for assessment of evaluability)
- •4. Subject must be a suitable candidate for oral antibiotic therapy and must be able to swallow capsules intact.
- •5. The subject must present with a recent respiratory illness which, upon consideration of the signs and symptoms after physical examination, is consistent with the diagnosis of bacterial CAP. Subjects requiring immediate study drug therapy before culture results are known may be entered with a presumptive diagnosis based on a chest radiograph which demonstrates a new pulmonary infiltrate(s) and at least two of the following categories of signs and symptoms:
- •fever (oral temperature >38.0°C or >100.4°F or equivalent tympanic or
- •rectal temperature);
- •development of, or increase in, dyspnea or tachypnea (elevated respiratory
- •rate =20/min);
- •auscultatory findings on pulmonary examination of rales and/or evidence of
- •pulmonary consolidation (i.e., dullness on percussion, bronchial breath
- •sounds [crackles, rhonchi, wheezes, or egophony]);
- •an elevated total peripheral white blood cell count (WBC >10,000/mm3); or
- •>15% immature neutrophils (bands), regardless of total peripheral WBC
- •count; or leukopenia with WBC <4500/mm3
- •6. Subjects are required to have specimens collected for microbiological
- •documentation within 48 hours prior to enrollment. Specimens should include:
- •Mucopurulent or purulent respiratory/sputum sample for testing via Gram
- •stain, culture and susceptibility testing;
- •Blood samples for culture of typical aerobic microorganisms (aerobic bottle
- •only, X 2 samples) and serology for atypical pathogens (L. pneumophila, M.
- •pneumoniae, and C. pneumoniae):
- •Urine sample for antigen detection of L. pneumophila.
- •(NOTE: Subjects will be
排除标准
- •1. A prior hospitalization within previous 4 weeks or residence at a chronic care
- •2. Evidence of active tuberculosis (or other mycobacterial infections), empyema, lung
- •abscess, pulmonary embolism, pulmonary edema, cystic fibrosis, tumor (primary or
- •metastatic) involving the lung, bronchial obstruction, a history of post obstructive
- •pneumonia (chronic obstructive pulmonary disease is not an exclusionary criterion),
- •or known or suspected Pneumocystis carinii pneumonia.
- •3. Treatment with a long-acting injectable antimicrobial agent (e.g., penicillin G
- •benzathine) within 4 weeks, treatment with ceftriaxone, azithromycin or
- •dirithromycin antibiotics within 7 days, or subjects who have received more than 24
- •hours of treatment with other antibiotics within 7 days prior to study drug
- •administration.
- •4. Any infection which necessitates the use of a concomitant antimicrobial agent, in
- •addition to study drug.
- •5. History of hypersensitivity or allergic reactions to macrolide, ketolide, quinolone,
- •azalide or streptogramin antimicrobials.
- •6. Treatment with an investigational drug within 4 weeks prior to study drug
- •administration.
- •7. Females who are pregnant or lactating.
- •8. Subjects with known significant renal or hepatic impairment (or disease) indicated
- •by recent chemistries:
- •serum creatinine =2.0 mg/dl (172 µmole/1iter);
- •SGOT (AST) >2X the upper limit of the reference range;
- •SGPT (ALT) >2 X the upper limit of the reference range;
- •total bilirubin =1.5 X the upper limit of the reference range.
- •9. Subjects with history of impaired renal function:
- •A creatinine clearance rate (CrCL) <50 mL/min. The CrCL will be calculated based
- •upon clinical laboratory tests obtained at Evaluation 1 and according to the
- •following formulae:
- •MEN CrCL (mL/min) = Body Weight (kg) x (140 - age in years)
- •72 x serum creatinine (mg/dL)
- •WOMEN CrCL (mL/min) = 0.85 x value calculated for men
- •10. Evidence of uncontrolled clinically significant cardiovascular, pulmonary,
- •metabolic, gastrointestinal, neurological or endocrine disease, malignancy, or other
- •abnormality (other than the disease being studied).
- •11. Subjects who would require parenteral antimicrobial therapy for treatment of
- •pneumonia should not be enrolled into the study.
- •12. Any underlying condition or disease state that would interfere with the completion of the study procedures and evaluations or absorption of study drug.
- •13. Currently receiving or are likely to require any of the following medications during
- •the period between 2 weeks prior to Evaluation 1 (initial presentation to
- •office/clinic) and within 24 hours after the last dose of study drug:
- •astemizole (Hismanal®), or pimozide (Orap®).
- •14. Currently receiving or are likely to require any of the following medications during
- •the period between Evaluation 1 (initial presentation to office/clinic) and within 24
- •hours after the last dose of study drug:
- •concomitant theophylline, or any theophylline analogue, unless adequately
- •monitored (either clinically or by plasma levels) during the study. If plasma
- •levels for theophylline will be monitored, the sample will be collected in the
- •same tube as the safety chemistry sample and measured and reported by the
- •central laboratory.
- •carbamazepine, dexamethasone, phenobarbital, phenytoin, St. John’s Wort,
- 另有 3 项未显示
研究者
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