EUCTR2006-002110-35-NL进行中（未招募）1 期
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 (CAP) in Adults
相关药物
试验速览
- 阶段
- 1 期
- 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)
- •A male subject must be willing to utilize a highly effective method of birth control (i.e., condom, abstinence) and must make all efforts to avoid fathering children while participating in this study.
- •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. If the radiologist does NOT confirm CAP, the subject should not be automatically withdrawn from the study. Subjects should continue in the study based on the signs and symptoms of pneumonia as interpreted by the investigator. These subjects will be classified as indeterminate at Test-of-Cure Visit 4.)
- •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 (based on local labs, if available)
排除标准
- •1. Prior hospitalization within previous 4 weeks or residence at chronic care facility.
- •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, history of post obstructive pneumonia (chronic obstructive pulmonary disease is not exclusionary), 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. Prior to enrollment, treatment with 1 dose of a short-acting antibiotic (e.g., amoxicillin, clarithromycin) is allowed if necessary.
- •4. Any infection which necessitates 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) based on historical medical data or known local laboratory chemistries prior to visit 1 enrollment:
- •serum creatinine =2.0 mg/dl (172 ?mole/liter)
- •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
- •GGT > 2X the upper limit of the reference range
- •9. Subjects with history of impaired renal function based on historical medical data or known local laboratory chemistries prior to visit 1 enrollment:
- •A creatinine clearance rate (CrCL) <50 mL/min. During the study, the CrCL will be calculated 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.
- •11. Subjects who would require parenteral antimicrobial therapy for treatment of pneumonia should not be enrolled.
- •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 likely to require any of the following medications during the period between 2 weeks prior to Evaluation 1 and within 24 hours after last dose of study drug:
- •astemizole (Hismanal®), or pimozide (Orap®).
- •14. Currently receiving or likely to require any of the following medications during the period between Evaluation 1 and within 24 hours after 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, sample will be collected in same tube as safety chemistry sample and measured and reported by the central laboratory.
- •carbamazepine, dexamethasone, phenobarbital, phenytoin, St. John’s Wort, lamotrigine, troglitazone, warfarin and digitalis glycoside. Other barbiturates may be us
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