Open-label, Multicentre, Randomized, Parallel Group Study to Assess the Efficacy and Safety of Oxygen-ozone Therapy Plus Oral Antibiotic Therapy in the Treatment of Infections Secondary to Implant of Orthopaedic Devices
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 186
- 试验地点
- 7
- 主要终点
- Clinical success at Day 14
研究概览
简要总结
This is an open-label, multicentre, randomized, parallel group study to evaluate the efficacy of treatment with oxygen-ozone therapy plus oral antibiotic therapy, in comparison with oral antibiotic therapy alone, in the proportion of patients with resolution/improvement of signs and symptoms of infection of the wound (e.g. ulcer, eschar, sore) in the target lesion after 14 days of treatment, in patients with infections secondary to implant of orthopaedic devices.
详细描述
This will be an open-label, multicentre, randomized, parallel group study. The study plan will include a screening visit (Visit 1, Day -7/-3) in which patients will be screened on the basis of inclusion/exclusion criteria and clinically evaluated.
At the end of the 3-7 days of run-in (Visit 2, Baseline visit, Day 0), patient still eligible will be randomised to one of the two following treatment groups:
- Oxygen-ozone therapy SIOOT plus antibiotic therapy
- Antibiotic therapy
Patients in both groups will receive oral antibiotic therapy, which will be prescribed at discretion of the Investigator, based on the results of the colture of the swab collected in the target lesion at the screening visit (and later, if needed) and the associated antibiogram.
Follow-up visits will be performed after 7 days (Visit 3, Day 7), 14 days (Visit 4, Day 14), 28 days (Visit 5, Day 28) and 42 days (Visit 6, End of study, Day 42) from the start of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent;
- •Male or female aged ≥ 18 years;
- •Patient having undergone surgery for implant of an orthopaedic device in the previous 8 weeks;
- •Presence of at least one (but no more than 3) post-operative wounds in the site of surgery (ulcers, eschars, sores);
- •Presence of at least one symptom (pain, burning, redness and malodour) and at least one sign (erythema, local warmth, swelling, purulent secretion) of infection of at least moderate intensity (score ≥ 2) in the target lesion at the screening visit (Visit 1), to be confirmed again at the baseline visit (Visit 2);
- •Wound area of the target lesion ≤ 100 cm2;
- •Patient with presence at least one pathogen identified in the swab collection in the target lesion, which is amenable to be eradicated with oral antibiotic therapy;
- •In case of multiple wounds (however not more than three), non-target lesions must not overlap with the target one (i.e. the largest one);
- •Patient able to perform the wound self-care at home or care by his/her primary caregiver;
- •Willing to refrain from all non-permitted concomitant medication from the screening visit through to the entire study duration.
- •Female subjects of childbearing potential must have a negative urinary pregnancy test at Screening and must practice a reliable method of contraception throughout the study;
- •Patient able to read and understand the study procedures, the requirements for follow-up visits, willing to provide information at the scheduled evaluations and willing, able and ensuring to comply with the study requirements for the whole study period.
排除标准
- •Wounds without signs of localized infection;
- •Presence of more than four wounds;
- •Presence of one or more wounds with area > 100 cm2;
- •Presence of undermining wounds;
- •Patients with favism, i.e. deficiency of the glucose-6-phosphate dehydrogenase (G6PD) enzyme;
- •Patients with uncontrolled hyperthyroidism;
- •Patients with history of connective tissue disease, e.g., mixed connective tissue disease;
- •Patients with active malignant disease;
- •Patients with other clinically significant diseases, or other major diseases deemed clinically significant by the Investigator or which in the opinion of the Investigator would interfere with the study procedures or study outcome;
- •Patients candidate to any surgery during the overall study duration;
- •Treatment with topical corticosteroids in the previous 4 weeks and/or with systemic corticosteroids in the previous 7 days;
- •Treatment with any hydrating and/or moisturizing cream in the previous 24 hours.
- •Patients on treatment with chemotherapeutic agents, radiation therapy or immunosuppressive therapies;
- •Patients with contraindications to antibiotic therapy;
- •Pregnant, breastfeeding women and female child-bearing potential who are not using a highly effective method of birth control and not willing to use it during the participation to the study;
- •Participation in any clinical research study evaluating another investigational drug or device within 30 days prior to consenting to study entry;
- •Patient unable to understand informed consent or having a high probability of non-compliance with the study procedures and or non-completion of the study according to investigator's judgement.
结局指标
主要结局
Clinical success at Day 14
时间窗: 2 week
Resolution/improvement of signs and symptoms of infection of the wound in the target lesion (i.e. a score ≤ 1 for a maximum of two signs/symptoms) from baseline to Day 14. The following symptoms will be evaluated by patients on a 0-4 point Likert scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom; 4 = very severe symptom): pain, burning, redness and malodour. The following signs will be evaluated by investigators on a 0-4 point Likert scale (0 = no sign; 1 = mild sign; 2 = moderate sign; 3 = severe sign; 4 = very severe sign): erythema, local warmth, swelling, purulent secretion.
次要结局
- Changes in High-sensitivity C-reactive protein(7 weeks)
- Eradication of the pathogen isolated at the screening visit(7 weeks)
- Global assessment of the target lesion at Day 14 and Day 42(7 weeks)
- Changes in WBCs count(7 weeks)
- Changes in Erythrocyte sedimentation rate(7 weeks)
- Proportion of patients with clinical success at Day 7, Day 28, and Day 42(Day 7, Day 28, and Day 42)
- Time to resolution of all signs and symptoms of infection(7 weeks)
- Changes from baseline to any post-baseline time-point of the size of the target lesion(7 weeks)
- Changes from baseline to any post-baseline time-point in body temperature(7 weeks)