CLINICAL TRIAL FOR COMMUNITY-ACQUIRED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS
CLINICAL TRIAL FOR COMMUNITY-ACQUIRED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS
批准号:
8881881
负责人:
ANDREW BOULTER
金额:
$184.5万
依托单位国家:
美国
项目类别:
财政年份:
2007
资助国家:
美国
项目状态:
已结题
起止时间:
2007-07-27 至 2015-12-31
关键词:
AbscessAdultAmoxicillinAntimicrobial ResistanceAreaCellulitisChildClavulanateClindamycinClinical TrialsCommunitiesContractsDrainage procedureInfectionOperative Surgical ProceduresPlacebosRegimenResearchSafetySeveritiesSkin TissueSoft Tissue InfectionsStaphylococcus aureusSubgroupTestingTherapeuticTrimethoprimVisitclinical efficacyclinically relevantcomparative efficacyfollow-upmethicillin resistant Staphylococcus aureusprogramssafety studytreatment strategy
中文摘要
社区获得性耐甲氧西林金黄色葡萄球菌(CA-MRSA)感染的临床试验计划为单纯性皮肤和软组织感染提供了临床相关的治疗策略,更具体地说,用于治疗化脓性感染(例如,脓肿)和非化脓性感染(例如,蜂窝织炎),在CA-MRSA流行的地区的儿童和成人中。主要目的-在治疗试验访问时确定的疗效:比较克林霉素和甲氧苄啶-磺胺甲恶唑联合手术引流治疗化脓性无并发症皮肤和软组织感染的疗效。� 比较克林霉素和甲氧苄啶-磺胺甲恶唑与安慰剂联合手术引流治疗大小和严重程度有限的化脓性无并发症皮肤和软组织感染的疗效。� 目的比较阿莫西林-克拉维酸与克林霉素治疗非化脓性感染的疗效。次要目的-在治疗结束和一个月随访时确定的疗效-比较治疗结束和一个月随访时研究方案的临床疗效-比较治疗结束和治愈试验访视时研究方案的安全性和耐受性。� 在儿童亚组和成人亚组中比较研究方案的疗效、耐受性和安全性。
英文摘要
The Clinical Trial for Community Acquired Methicillin-Resistant Staphylococcus Aureus (CA-MRSA) Infections program provides a clinically relevant treatment strategy for uncomplicated skin and soft tissue infections, more specifically, for treatment of suppurative infections (e.g., abscess) and nonsuppurative infections (e.g., cellulitis), in both children and adults in areas where CA-MRSA is prevalent. Primary objectives � Efficacy determined at a Test of Cure Visit: � To compare the efficacy of clindamycin and trimethoprim-sulfmethoxazole in conjunction with surgical drainage for suppurative uncomplicated skin and soft tissue infections. � To compare the efficacy of clindamycin and trimethoprim-sulfmethoxazole and placebo in conjunction with surgical drainage for suppurative uncomplicated skin and soft tissue infections of limited size and severity. � To compare the efficacy of amoxicillin-clavulanate and clindamycin for nonsuppurative infection. Secondary objectives � Efficacy determined at End of Treatment and One-Month Follow-Up � To compare clinical efficacy of study regimens at End of Treatment and at One-Month Follow-Up � To compare safety and tolerability of study regimens at End of Treatment and at Test of Cure Visit. � To compare efficacy, tolerability, and safety of study regimens in the subgroup of children and the subgroup of adults.
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Retrovirus Epidemiology Donor Study-II (REDS-II) Blood Center
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批准号:8051065
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项目类别:
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资助金额:$37.04万
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财政年份:2004
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负责人:ANDREW BOULTER
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依托单位:
RETROVIRUS EPIDEMIOLOGY DONOR STUDY-II, BLOOD CENTER
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批准号:7542907
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项目类别:
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资助金额:$85.53万
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财政年份:2004
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负责人:ANDREW BOULTER
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依托单位:--
海外基金