EUCTR2016-001528-69-IE进行中（未招募）1 期
PENICILLIN FOR THE EMERGENCY DEPARTMENT-DIRECTED OUTPATIENT TREATMENT OF CELLULITIS (PEDOCELL) STUDY: A NON-INFERIORITY ADAPTIVE RANDOMISED CONTROLLED TRIAL.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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.Clinically diagnosed cellulitis, wound infection & abscess affecting any body part, excluding the perineum, and having any two of the following signs:
- •Tenderness / Pain of affected area
- •Oedema / Induration
- •Regional lymphadenopathy
- •Purulent drainage
- •2.Cellulitis, wound infection & abscess deemed treatable with oral antibiotics on an outpatient basis
- •3.Patients with cellulitis, wound infection & abscess who have no signs of systemic toxicity and have no uncontrolled co-morbidities.
- •4.Written informed consent obtained.
- •5.16 years of age or older.
- •6.Fluency in written and spoken English.
- •7.Willing to return for study follow-up or to have the research nurse or clinical project coordinator visit them.
- •8.Willing to receive a telephone call from a study investigator.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1.Penicillin allergy (self-reported or confirmed).
- •2.Any cellulitis wound infection & abscess that treating clinicians deem treatable with intravenous (IV) antibiotics.
- •3.Patients that may have a significant systemic upset such as acute confusion, tachycardia, tachypnoea, hypotension or may have unstable co-morbidities that may interfere with a response to therapy or have a limb threatening infection due to vascular compromise.
- •4.Patients who may have a severe life threatening infection such as necrotizing fasciitis.
- •5.Any cellulitis wound infection & abscess of the perineal region.
- •6.Patients who have received more than 24 hours of effective antibiotics for the current episode of acute cellulitis, wound infection & abscess
- •7.Any medical condition, based on clinical judgment that may interfere with the interpretation of the primary outcome measures (e.g. a chronic skin condition at the site of the cellulitis wound infection or abscess).
- •8.Immunodeficiency from primary or secondary causes (e.g. corticosteroids, chemotherapeutic agents).
- •9.Previous history of renal dysfunction or known chronic kidney disease under the care of a nephrologist. ?
- •10.Previous history of liver dysfunction defined as chronically deranged liver function tests elicited from the medical notes or history.
- •11.Suspected or confirmed septic arthritis.
- •12.Suspected or confirmed osteomyelitis.
- •13.Infection involving prosthetic material.
- •14.Pregnant or lactating women.
- •15.Patients with a previous history of flucloxacillin-associated jaundice/hepatic dysfunction
- •16.Patients with a previous history of methicillin-resistant staphylococcus aureus (MRSA) colonisation/infection.
- •17.Patients with lactose intolerance diagnosed by a medical professional.
- •18.Patients currently taking probenecid, neomycin, chloramphenicol, erythromycin , tetracyclines sulfinpyrazone, methotrexate, guar gum or an oral anticoagulant.
研究者
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