NCT00100126已完成3 期
A Phase III, Investigator Blind, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of APC-231 Sprinkle QD for 7 Days vs Penicillin VK 10 mg/kg QID for 10 Days in Pediatric Patients With Streptococcus Pyogenes
Advancis Pharmaceutical Corporation3 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2004年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Bacteriological outcome at Test of Cure Visit
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of APC-231 QD for 7 days in the bacteriological outcome at the Test of Cure Visit.
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
- Single
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Give informed consent, assent, and documentation of patient authorization for disclosure of study results.
- •Since all patients are below the legal age of consent, assent from the patient must be obtained (as applicable following state regulations) and written informed consent obtained from the parent or legal guardian.
- •Age > = 6 months -12 years.
- •A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat or difficulty feeding or swallowing or irritability that suggests the presence of a sore throat with at least one of the following:
- •Tonsillar or pharyngeal exudate
- •Tender cervical lymph nodes
- •Fever or history of fever treated with antipyretics
- •Odynophagia
- •Uvular edema
- •Pharyngeal Erythema of moderate or greater intensity
- •Elevated white blood cell (WBC) >12,000/mm3 or 10% bands
- •Red tongue and prominent papillae (Strawberry tongue)
- •A positive rapid screening test for S. pyogenes (enzyme immunoassay; SiGNIFY™ Strep A Test).
- •Patient is an appropriate candidate for oral antibiotic therapy and can swallow the study dosage forms.
- •Females must be non-lactating and:
- •If of childbearing potential and sexually active, the patient must have a negative prestudy urine pregnancy test and be utilizing acceptable birth control methods throughout the study.
排除标准
- •Chronic or recurrent (two weeks duration two times per year) odynophagia or enlarged tonsils secondary to viral or proven bacterial etiology.
- •The need for hospitalization or I.V. antimicrobial therapy.
- •Pharyngitis known or suspected to be due to a pathogen resistant to beta-lactam antimicrobials.
- •Patients who are known carriers of S. pyogenes.
- •Previous allergy, serious adverse reaction to, or intolerance to, penicillin or any other member of the beta-lactam class of antimicrobials.
- •Any serious illness or concomitant condition that the investigator judges would preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also include:
- •Any rapidly progressive underlying disease with a shortened life expectancy.
- •The inability to swallow the study dosage form.
- •Unable to understand the requirements of the study.
- •Neutropenia (<1000 PMNs/mm3) or other known immunocompromised state.
- •Hard chills or rigors.
- •Seizure disorder or lowered seizure threshold. This does not exclude children with previous febrile seizures.
- •Psychiatric condition requiring use of major tranquilizers.
- •Pregnancy or nursing.
- •Expectation that additional effective systemic antibacterials would be required for any condition during the duration of the study.
- •Current drug or alcohol abuse.
- •Receipt of any experimental drug or medical device within the previous 30 days (or are scheduled to receive any other experimental procedures during the study period).
- •Previous treatment under this protocol.
- •Systemic antimicrobial therapy with benzathine penicillin within 30 days or azithromycin within 14 days.
- •Hospitalization within the month prior to study admission, during which antibacterial therapy was administered.
- •The presence of clinically significant hematologic conditions or cardiac valvular disease.
- •History of cardiovascular disease, renal disease, or neurological disease secondary to previous infection with S. pyogenes.
- •Probenecid treatment or systemic steroids during the duration of the study.
结局指标
主要结局
Bacteriological outcome at Test of Cure Visit
次要结局
- Bacteriological outcome at Late Post Therapy Visit
- Clinical Outcomes
- Safety
研究者
研究点 (3)
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