EUCTR2014-000714-65-BE进行中（未招募）1 期
Evaluation of phage therapy for the treatment of Pseudomonas aeruginosa wound infections in burned patients (Phase I-II clinical trial) - PHAGOBUR
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 125
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
- •Man or woman 18 years old or more
- •Informed consent obtained from patient or next of kin
- •In-hospital patient treated for burn wounds in a burn unit
- •Burn wounds with a microbiologically documented infection defined by positive surface swab, due to P. aeruginosa whatever their resistance profile.
- •As poly-microbial infections are usual in burn wounds infection, when one another bacterial specie is also present on the wound, the patient may be included whether this specie is rare and overwhelmed by the targeted strain (daily swabs will support monitoring the burden of the colonizing specie)
- •Patients with local infection due to P. aeruginosa without general signs.
- •Patients with local infection due to P. aeruginosa and general signs, and without antibiotic treatment.
- •Patients with local infection due to P. aeruginosa and general signs, and with active or non-active antibiotic treatment at the inclusion (randomization and stratification).
- •Patients with local infection due to P. aeruginosa and general signs, and with non-active antibiotic treatment during the protocol.
- •Patients with local infection due to P. aeruginosa and general signs, and treated with active antibiotic treatment during the protocol must be considered as failure of local treatment.
- •Burn wound (grafted or not) or donor site, presenting local signs of infection defined by one or more of the following SFETB criteria:
- •- A local or loco-regional inflammatory reaction;
- •- And/or an adverse and unexpected local evolution;
- •- And/or regarding burn wounds: presence of pus, fast spontaneous debridement and separation, occurrence of blackish spots (necrosis or hemorrhage), unexplained conversion from a superficial lesion to a deep one (> 48th hour);
- •- And/or regarding graft donor sites: presence of pus, unexplained delay in epidermisation, bed sore;
- •- And/or regarding graft recipient sites: presence of pus, lysis of grafts, necrosis of fat located under the graft.
- •Patient treated by povidone-iodine, or any dressing without silver for more than one day before inclusion
- •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 125
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant or breastfeeding woman
- •Undercurrent condition requiring a treatment which may interfere with analysis results: such as high dose of chronic corticotherapy, immunosuppressive medication, oncologic chemotherapy (but antibiotic treatment is not an exclusion criterion, see below).
- •Patient included in an interventional research protocol with therapeutic intervention still ongoing upon inclusion time or having participated into anti-infective drug trials during the previous month.
- •Patient with a secondary colonization by another species than P. aeruginosa if the colonization level is growing to infection
- •Patient considered as part of a vulnerable population as defined by the ICH.
- •Patient for whom treatment limitation or withdrawal during study period is considered.
- •Patient with general or local sensitization to Sulphonamide (contact dermatitis)
- •Patients previously included in this study.
- •Patients who have experienced an increase in the SOFA score greater than or equal to 2 during the 48 hours preceding the inclusion day.
研究者
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