EUCTR2011-003741-17-BG进行中（未招募）不适用
Randomized, Dose Ranging, Active Controlled Efficacy and Safety Evaluation of PMX-30063 As Initial Treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Caused by Staphylococcus aureus
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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. Provide written informed consent
- •2. Be = 18 years of age and <85 years of age
- •3. Have a diagnosis of ABSSSI in which S. aureus is clinically suspected to be the likely pathogen
- •4. Clinical manifestation of subjects’ ABSSSI must include the presence of purulent material suitable for microbiologic culture, Gram stain examination and PCR assay.
- •5. The ABSSSI must be 75 cm2 or greater in size in order for the subject to be eligible for this study. This includes the primary lesion and surrounding erythema, swelling or induration.
- •6. Have not received more than 24 hours of active treatment with another systemic antibiotic for the current ABSSSI within 72 hours prior to randomization, unless resistance has been established by showing that there is:
- •a. Clinical evidence of treatment failure following at least 48 hours of prior systemic antimicrobial therapy; OR
- •b. Microbiological evidence of failure including EITHER a Gram stain which reveals white blood cells and Gram-positive cocci in clusters obtained at least 48 hours after the first dose of a prior systemic antibacterial
- •prior isolation of a S. aureus organism which is resistant in vitro to the prior systemic antibacterial therapy at any time after initiation of such antibiotic therapy.
- •c. Positive PCR assay (Xpert® MRSA/SA SSTI) for S. aureus.
- •Note: not all sites will have PCR technology available. When sites do not have Xpert®MRSA/SA SSTI (Cepheid, Sunnyvale, CA) technology, inclusion criteria c” is not applicable.
- •7. Requires parenteral therapy for the infection, which is expected to continue for at least 7 days
- •8. Presents with at least TWO of the following local symptoms of infection:
- •a. Erythema
- •b. Fluctuance
- •c. Heat/Localized Warmth
- •d. Pain/tenderness to palpation
- •e. Swelling/induration
- •f. Lymph node enlargement and/or tenderness in the area of drainage from the infected site
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Female patients who are pregnant, lactating (breast milk feeding), or planning a pregnancy during the course of the study. Woman of child bearing potential (WOCBP)* who are not using an acceptable method of birth control (i.e., intrauterine device, oral contraceptive plus barrier contraceptive, hormone delivery system plus barrier contraceptive or condom in combination with
- •contraceptive cream, jelly or foam). WOCBP with a positive urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product.
- •*WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea = 12
- •consecutive months; or women on hormone replacement therapy with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL).
- •2. History of peripheral neuropathy of any form or etiology
- •3. Anticipated need for prolonged antibiotic therapy (i.e., >8 days)
- •4. ABSSSI known or suspected to be caused exclusively by Gram negative pathogens or anaerobes (both Gram positive or Gram negative)
- •5. ABSSSI known or suspected to be caused by non-bacterial infections
- •6. Known or suspected osteomyelitis or septic arthritis
- •7. Super-infected eczema or other chronic medical conditions (e.g., atopic dermatitis, hidradentitis suppurativa) characterized by prominent signs of inflammation for an extended period even after successful bacterial eradication. (Subjects with an ABSSSI that involves an anatomic location in which there is no evidence of a chronic skin condition are eligible for enrollment.)
- •8. Diabetic foot infection: defined as a subacute or chronic infection (> 4 weeks) below the ankle in a patient with diabetic neuropathy
- •9. Infected burns
- •10. Chronic skin ulcer present for over 2 months
- •11. Peri-rectal abscess or infected pilonidal cyst
- •12. Infected decubitus ulcer
- •13. Infection associated with severe peripheral vascular insufficiency: defined as patients with prior vascular surgery of the lower extremities or the presence of distal gangrene.
- •14. Infection resulting from human or animal bite (infection from insect bite is eligible)
- •15. Suspected necrotizing fasciitis
- •16. Unable or unwilling to adhere to the study-specified procedures and restrictions
- •17. Infections related to the presence of prosthetic materials that will not be removed such as permanent intra-cardiac devices or joint replacement prostheses
- •18. Moderately or severely impaired renal function with known creatinine clearance <50 mL/min (based on the Cockcroft-Gault formula using ideal body weight)
- •19. ALT or AST >2x upper limit of normal or bilirubin >1.5 x upper limit of normal (ULN) at baseline
- •20. Neutropenia defined as an absolute neutrophil count < 0.5 x 103/L
- •21. Thrombocytopenia defined as a platelet count <50 x 103/L
- •22. Prolonged QTc interval >450 msec at baseline or history of prolonged QT syndrome
- •23. Known infection with human immunodeficiency virus (HIV) and a CD4 count < 200/mm3
- •24. Active hepatitis B or hepatitis C receiving treatment with interferon or other immunosuppressive therapy
- •25. History of penicillin hypersensitivity reaction (allergy) if subject is to receive concomitant penicillin
- •26. Life expectancy of less than 3 months from the time of enrollment
- •27. The presence of a significant risk factor for a poor clinical
研究者
相似试验
进行中（未招募）
1 期
A Randomized, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly with Peginterferon alfa-2b and Ribavirin in Treatment-Naive Patients with Chronic Genotype 1 Hepatitis C Virus InfectioHepatitis C Virus InfectionMedDRA version: 14.0 Level: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestationsEUCTR2011-000759-18-ITMERCK SHARP & DOHME CORP.368
进行中（未招募）
1 期
Development of MK-5172 in combination with peginterferon plus ribavirin for the treatment of chronic hepatitis C virus infection in treatment-naive patients.Chronic Genotype 1 Hepatitis C Virus Infection in treatment-naive patientsMedDRA version: 14.0 Level: LLT Classification code 10019751 Term: Hepatitis C virus System Organ Class: 10022891 - InvestigationsEUCTR2011-000759-18-BEMerck Sharp & Dohme Corp.,a subsidiary of Merck&Co.,Inc.368
进行中（未招募）
不适用
AEUCTR2011-000759-18-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., USA650
招募中
不适用
Clinical Trial to Evaluate the Efficacy and Safety of Intra-articular DA-5202 in Patients with Osteoarthritis of the KneeDiseases of the musculo-skeletal system and connective tissueKCT0001699Dong-A ST120
招募中
不适用
A Clinical Study in AGHD to Assess Safety, Tolerability and Efficacy of GX-H9Endocrine, nutritional and metabolic diseaseKCT0001682Genexine60