PER-054-01已完成未知
RANDOMIZED, DOUBLE-BLIND, MULTICENTRIC COMPARATIVE STUDY, PHASE III, WITH TWO COURSES OF DIFFERENT THERAPY WITH BMS-284756 ORAL VS AMOXICILLINE / ORAL CLAVULANATE IN THE TREATMENT OF ACUTE SINUSITIS
BRISTOL MYERS SQUIBB PERU S.A.,0 个研究点目标入组 0 人开始时间: 2001年8月7日最近更新:
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
- 年龄范围
- 0 至 0（—）
入选标准
- •Men or women of eighteen years of age or older, in whom oral therapy is indicated;
- •Subjects with clinical signs and symptoms consistent with acute maxillary sinus infection, proven by:
- •1) Pain and / or facial hypersensitivity in one or both maxillary areas (the duration of the signs and symptoms of sinusitis is more than 7 days and less than 28 days),
- •2) Two or more of the following signs / symptoms / laboratory findings:
- •(a) Fever (oral temperature> 38 ° C or> 100.4 ° F, tympanic temperature> 38.5 ° C or> I01.2 ° F, or rectal temperature> 39 ° C or> 102.2 = F),
- •(b) Leukocytosis (> 10,000 leukocytes / mm or> 15% band forms),
- •(c) Nasal congestion,
- •(d) Postnasal drainage,
- •(e) Frequent cough,
- •(f) Headache.
- •3) At least one of the following findings on the physical examination.
- •(a) Purulent discharge from the maxillary sinus orifice, or
- •(b) Purulent discharge from the nose, or
- •(c) Purulent drainage in the posterior pharynx.
- •The informed consent of the subject or his legally authorized representative must be obtained
- •Women of childbearing age (MEF) must have a serum or urine pregnancy test with a negative result (minimum sensitivity 25 IU / L or its equivalent in units of HCG) obtained in the 48 prior to the start of the administration of the drug of the study.
排除标准
- •Subjects presenting with a current episode of sinusitis with symptoms for more than 28 days;
- •Three or more episodes of acute sinusitis in the previous six months,
- •Complicated sinusitis (eg, Pott´s swollen tumor, malignancy affecting the breast, osteomyelitis, infection of the contiguous bone, or need for reconstructive surgery);
- •Anatomical abnormality that involves the ostium of the maxillary sinus and that would damage the sinus drainage, being able to affect the response to the therapy (for example, post-traumatic or post-surgical defect);
- •Recent surgery of the nose or sinuses (that is, in the 3 months prior to admission);
- •Nosocomial sinusitis secondary to head trauma or nasotracheal intubation;
- •Have received more than a single dose of any therapy with systemic antibiotics in the 7 days prior to admission, or probability of receiving other systemic antibiotics during their participation in the study;
- •Subjects who, in the opinion of the Investigator, may require long-term antibacterial therapy (for more than 10 days);
- •Subjects with cystic fibrosis;
- •Current known and clinically significant liver disease, or known levels of ALT and / or AST and / or total bilirubin times the normal maximum limit;
- •Known renal insufficiency (eg, serum creatinine> 2.0 mg / dL [176.7 pmol / L] or requiring renal dialysis);
- •History of serious hypersensitivity reaction (eg, urticaria, anaphylaxis) to any quinolone or beta-lactam compound,
- •Subjects with previous diagnosis of immune system disease (s) (eg, AIDS, current neutrophil count <1000 / mm ^);
- •Malabsorption syndromes or other gastrointestinal disorders that affect the absorption of the medication;
- •Use of a research agent concomitantly or within 30 days, immediately prior to admission in this study;
- •Pregnancy and / or lactation;
- •Fertile women who are not using an adequate birth control method,
- •Have been previously admitted to any study with BMS-284756;
- •Presence of any disorder or disease that may interfere with the evaluation of the study medication and / or due to which, in the opinion of the investigator, it would not be appropriate to admit the subject in the study.
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