NCT02664740尚未招募1 期
Comparison of the Efficacy of Standard Treatment Associated With Phage Therapy Versus Standard Treatment Plus Placebo for Diabetic Foot Ulcers Monoinfected by Staphylococcus Aureus: a Randomized, Multi-centre, Controlled, 2-parallel-group, Double-blind, Superiority Trial
Centre Hospitalier Universitaire de Nīmes6 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- The relative reduction in wound surface area (%)
研究概览
简要总结
The primary objective of this study is to compare the efficacy of standard treatment associated with a topical anti-staphylococcal bacteriophage cocktail versus standard treatment plus placebo for diabetic foot ulcers monoinfected by methicillin-resistant or susceptible S. aureus (MRSA or MSSA) as measured by the relative reduction in wound surface area (%) at 12 weeks.
详细描述
The secondary objectives of this study are:
A. To compare the two study arms in terms of treatment safety and tolerance throughout the study.
B. To compare the two study arms in terms of further changes in wound healing at weeks 2, 4, 6, 8, 10, 12.
C. To describe the changes in the resistance and virulence of S. aureus (if present in the wound) from baseline to week 4, at modification of the first-line treatment or new antibiotic prescription (if any) and at week 12 if the wound is still not healed.
D. To describe in the two study arms the antibiotic resistance status of other bacteria isolated from wounds at week 4, at modification of the first-line treatment or new antibiotic prescription (if any) and at week 12 if the wound is still not healed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Participant pre-inclusion criteria:
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is at least 18 years old
- •The patient has type 1 or type 2 diabetes
- •The patient is hospitalized/consulting in a participating centre
- •The patient has a wound below the ankle that has be evolving for >2 weeks
- •The patient has a neuropathic foot wound, classified S (0 or 1), I (0 or 1), N (1), B (1), A (0 or1) and D (1) according to the SINBAD classification,
- •without ischaemia or with non-critical ischaemia defined by: ankle arterial pressure > 50 mm Hg or toe systolic arterial pressure > 30 mm Hg or TcpO2 > 30 mm Hg )
- •with a surface area ≥ 0,5 cm2
- •With IWGDF/IDSA grade 2 or 3 infection without osteomyelitis (normal radiography*)
- •Females of childbearing potential or Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices) for 1 month after the last study drug administration
- •Negative pregnancy test must be obtained before starting any experimental drug
- •Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months)
- •Participant final inclusion criteria:
- •The patient has a neuropathic foot wound:
- •Classified S (0 or 1), I (0 or 1), N (1), B (1), A (0 or1) and D (1) according to the SINBAD classification,
- •without ischaemia or with non-critical ischaemia defined by: ankle arterial pressure > 50 mm Hg or toe systolic arterial pressure > 30 mm Hg or TcpO2 > 30 mm Hg )
- •with a surface area ≥ 0,5 cm2
- •With IWGDF/IDSA grade 2 or 3 infection without osteomyelitis
- •The patient's wound is monoinfected by methicillin-resistant or susceptible S. aureus (MSSA or MRSA ), or infected by MSSA or MRSA and other bacteria (a total of 3 bacteria when accounting for MSSA or MRSA)
- •The Phagogram of the patient demonstrated that the strains are susceptible to at least one phage(PP1493 and/or PP1815).
- •Participant pre-
排除标准
- •The patient is participating in, or has participated in over the past three months, another trial
- •The patient is participating in, or has participated in over the past three months, another study that may interfere with the results or conclusions of this study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, or is an adult under guardianship
- •It is impossible to correctly inform the patient
- •The patient refuses to sign the consent
- •The patient is pregnant, parturient or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the treatment period and 1 month after the last administration of study drug
- •Women/Men refusing to use an effective contraception during and1 month after the last administration of study drug
- •Participant final exclusion criteria:
- •The patient refuses to participate to the study
- •The patient is pregnant, parturient or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the treatment period and 1 month after the last administration of study drug
- •Women/Men refusing to use an effective contraception during and1 month after the last administration of study drug
- •Patients with diabetic foot wounds associated with clinical or radiographic signs of arthritis or osteomyelitis*
- •Patient is not infected by S. aureus or infected by more than 3 bacteria even if the culture isolates a S. aureus.
研究组 & 干预措施
Phage therapy
Experimental
Patients randomized to this arm will have phage therapy.
Intervention: Topical anti-Staphylococcus bacteriophage therapy
干预措施: Topical anti-Staphylococcus bacteriophage therapy (Drug)
Placebo
Placebo Comparator
Patients randomized to this arm will have placebo therapy anologous to that of the experimental arm.
Intervention: Topical placebo corresponding to anti-Staphylococcus bacteriophage therapy
干预措施: Topical placebo corresponding to anti-Staphylococcus bacteriophage therapy (Drug)
结局指标
主要结局
The relative reduction in wound surface area (%)
时间窗: 12 weeks
次要结局
- Wound surface area(12 weeks)
- Wound microbiota: OTU richness(at week 12 if the wound is still not healed)
- Immediate Safety(Day 14, 1 hour after application of experimental dressing)
- Time to healing(censored at 12 weeks)
- The number of MedDRA coded Adverse Events per patient(throughout the study; 12 weeks)
- The presence/absence of abnormal laboratory results(throughout the study; 12 weeks)
- Wound depth(12 weeks)
- The % of completely healed wounds(12 weeks)
- Classification of Staphylococcus isolates according to clonal complexes (virulence classification)(at week 12 if the wound is still not healed)
- Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant(at week 12 if the wound is still not healed)
- Wound microbiota: Functional richness(at week 12 if the wound is still not healed)
- Classification of Staphylococcus isolates as MSSA or MRSA resistant(at week 12 if the wound is still not healed)
- Wound microbiota: the number of Staphylococcus strains in a wound(at week 12 if the wound is still not healed)
- Wound microbiota: Shannon's Diversity(at week 12 if the wound is still not healed)
- Wound microbiota: Functional diversity(at week 12 if the wound is still not healed)
- The presence/absence of anti-phage antibodies in plasma samples(at week 12 if the wound is still not healed)
- Wound microbiota: the relative abundance of Staphylococcus relative to other bacteria in the wound(at week 12 if the wound is still not healed)
- Wound microbiota: ordination scores on each of two principal components extracted from UniFrac distances between all bacterial samples taken during the study(at week 12 if the wound is still not healed)
- Wound microbiota: the relative abundance of Staphylococcus aureus relative to other bacteria in the wound(at week 12 if the wound is still not healed)
- Wound microbiota: the relative abundance of Staphylococcus aureus relative to other Staphylococcus in the wound(at week 12 if the wound is still not healed)
- Wound surface area(8 weeks)
- Wound surface area(10 weeks)
- Wound depth(2 weeks)
- Wound depth(4 weeks)
- Wound depth(6 weeks)
- Wound depth(8 weeks)
- Wound depth(10 weeks)
- Wound microbiota: Functional richness(week 0)
- Immediate Safety(Day 0, 1 hour after application of experimental dressing)
- Immediate Safety(Day 7, 1 hour after application of experimental dressing)
- Wound surface area(2 weeks)
- Wound surface area(4 weeks)
- Wound surface area(6 weeks)
- Classification of Staphylococcus isolates as MSSA or MRSA resistant(4 weeks)
- Classification of Staphylococcus isolates as MSSA or MRSA resistant(at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks))
- Classification of Staphylococcus isolates according to clonal complexes (virulence classification)(4 weeks)
- Classification of Staphylococcus isolates according to clonal complexes (virulence classification)(at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks))
- Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant(week 0)
- Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant(week 4)
- Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant(at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks))
- Wound microbiota: OTU richness(week 0)
- Wound microbiota: OTU richness(week 4)
- Wound microbiota: OTU richness(at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks))
- Wound microbiota: Shannon's Diversity(week 0)
- Wound microbiota: Shannon's Diversity(week 4)
- Wound microbiota: Shannon's Diversity(at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks))
- Wound microbiota: Functional richness(week 4)
- Wound microbiota: Functional richness(at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks))
- Wound microbiota: Functional diversity(week 0)
- Wound microbiota: Functional diversity(week 4)
- Wound microbiota: Functional diversity(at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks))
- Wound microbiota: the relative abundance of Staphylococcus relative to other bacteria in the wound(week 0)
- Wound microbiota: the relative abundance of Staphylococcus relative to other bacteria in the wound(week 4)
- Wound microbiota: the relative abundance of Staphylococcus relative to other bacteria in the wound(at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks))
- Wound microbiota: the number of Staphylococcus strains in a wound(week 0)
- Wound microbiota: the number of Staphylococcus strains in a wound(week 4)
- Wound microbiota: the number of Staphylococcus strains in a wound(at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks))
- Wound microbiota: the relative abundance of Staphylococcus aureus relative to other bacteria in the wound(week 0)
- Wound microbiota: the relative abundance of Staphylococcus aureus relative to other bacteria in the wound(week 4)
- Wound microbiota: the relative abundance of Staphylococcus aureus relative to other bacteria in the wound(at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks))
- Wound microbiota: the relative abundance of Staphylococcus aureus relative to other Staphylococcus in the wound(week 0)
- Wound microbiota: the relative abundance of Staphylococcus aureus relative to other Staphylococcus in the wound(week 4)
- Wound microbiota: the relative abundance of Staphylococcus aureus relative to other Staphylococcus in the wound(at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks))
- Wound microbiota: ordination scores on each of two principal components extracted from UniFrac distances between all bacterial samples taken during the study(week 0)
- Wound microbiota: ordination scores on each of two principal components extracted from UniFrac distances between all bacterial samples taken during the study(week 4)
- Wound microbiota: ordination scores on each of two principal components extracted from UniFrac distances between all bacterial samples taken during the study(at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks))
- The presence/absence of anti-phage antibodies in plasma samples(week 0)
- The presence/absence of anti-phage antibodies in plasma samples(week 4)
- The presence/absence of anti-phage antibodies in plasma samples(at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks))
研究者
研究点 (6)
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