PER-020-01已完成未知
Prospective, double-blind, double-masked, randomized, comparative, parallel group, multicenter and multinational phase III trial to evaluate the efficacy and safety of faropenem dainxate 300 mg orally twice daily for 5 days against penicillin V 1,000,000 Ul orally three times a day for 10 days in the treatment of acute pharyngitis or streptococcal tonsillitis in adult patients.
BAYER S.A.,0 个研究点目标入组 0 人开始时间: 2001年5月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Male patient or woman with 18 or more years of age.
- •Patients with a clinical diagnosis of suspected strep throat or streptococcal tonsillitis.
- •Patients with a positive result in the rapid antigen detection test (RADT) for Group A p-hemolytic streptococci performed on a pharyngeal sample.
- •Patients to whom a deep pharyngeal sample appropriate for the culture has been extracted before the start of treatment.
- •Written informed consent signed by the patient or their legal representative before entering the study.
- •Women of childbearing age, including women in the postmenopausal period for less than 1 year and / or without surgical sterilization, should use reliable contraceptive methods during exposure to the study drug. Since the interaction studies between faropenem daloxate and oral contraceptives have not been completed, a barrier method of contraception should be used during the time of administration of the study drug.
排除标准
- •Patients who are known carriers of S. pyogenes.
- •Patients treated for pharyngitis or streptococcal tonsillitis within 30 days before inclusion in the study.
- •Patients with periamigdalar abscess or other locally invasive diseases (such as otitis or meningitis)
- •Pregnant or lactating patients, who use inadequate contraceptive methods or in which the pregnancy can not be ruled out.
- •Patients who can not tolerate oral medication.
- •Signs and symptoms or tests that suggest the existence of a viral infection of the upper respiratory tract (eg cough, acute rhinorrhea, conjunctivitis, positive results in the reaction of heterophile antibodies).
- •History of rheumatic fever or glomerulonephritis.
- •Patients with known neutropenia (<1,000 / mm3),
- •Patients with known AIDS (guideline, if data are available: CD4 count <5on / mm3) or under highly active antiretroviral therapy (HAART). An HIV test is not required.
- •Patients with known significant hepatic impairment (baseline serum transaminases> twice the upper normal limit or bilirubin> 1.5 times the upper normal limit).
- •Patients with known renal insufficiency (serum creatinine> 2.0 mg / dl, 177 umol / l)
- •Patients who have been diagnosed with a disease of rapid fatal outcome, with death expected in 2 months
- •Patients requiring other systemic antibiotics during the study.
- •Patients who have received a systemic antibacterial agent during the 3 days prior to inclusion
- •Patients with a history of allergy to beta-lactams (penicillins, cephalosporins, penemes, etc.), or related compounds.
- •Patients who have already participated in this trial or in any study on faropenem daloxato.
- •Patients who have taken any investigational drug in the last 30 days.
研究者
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