Back to resultsStandard Treatment Associated With Phage Therapy Versus Placebo for Diabetic Foot Ulcers Infected by S. Aureus (PhagoPied)
Primary Purpose
Diabetic Foot, Staphylococcal Infections
Status
Not yet recruiting
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Topical anti-Staphylococcus bacteriophage therapy
Topical placebo corresponding to anti-Staphylococcus bacteriophage therapy
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot focused on measuring Phage Therapy
Eligibility Criteria
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 target wound is classified as P (1 or 2), E (1-30 cm^2), D (2), I (2) and S (1 or 2) according to the PEDIS classification
Participant final 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 target wound is classified as P (1 or 2), E (1-30 cm^2), D (2), I (2) and S (1 or 2) according to the PEDIS classification
- The patient's wound is mono-infected with Staphylococcus aureus (MRSA or MSSA)
Participant pre-exclusion criteria:
- 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
Participant final exclusion criteria:
- 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 who have received antibiotics within the 7 days preceding inclusion
- Patients with diabetic foot wounds associated with clinical or radiographic signs of arthritis or osteomyelitis*
- Patients with diabetic foot wounds associated with critical limb ischemia according to P = grade 3 in the PEDIS classification
- Patients whose wound is infected by a pathogen other than S. aureus (includes multi-infections) according to bacteriological sampling performed at the pre-inclusion visit
Sites / Locations
- CHU de Bordeaux - Hôpital Pellegrin
- CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
- CHU de Nantes - Hôtel Dieu
- APHP - Groupe Hospitalier Pitié-Salpetrière
- APHP - Hôpital Lariboisière
- CHRU de Toulouse - Hôpital de Rangueil
- CH de Tourcoing
- Institut Robert Merle d'Aubigné
- CH Intercommunal de Villeneuve-Saint-Georges
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Phage therapy
Placebo
Arm Description
Patients randomized to this arm will have phage therapy. Intervention: Topical anti-Staphylococcus bacteriophage therapy
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
Outcomes
Primary Outcome Measures
The relative reduction in wound surface area (%)
Secondary Outcome Measures
Immediate Safety
The presence/absence of the following symptoms during each 1 hour observation periods following the application of each experimental wound dressing: local side effects (local rash onset or worsening of local inflammatory signs) and general symptoms (vital signs, fever, rash, arthralgia, gastro-intestinal symptoms...) will be performed.
Immediate Safety
The presence/absence of the following symptoms during each 1 hour observation periods following the application of each experimental wound dressing: local side effects (local rash onset or worsening of local inflammatory signs) and general symptoms (vital signs, fever, rash, arthralgia, gastro-intestinal symptoms...) will be performed.
Immediate Safety
The presence/absence of the following symptoms during each 1 hour observation periods following the application of each experimental wound dressing: local side effects (local rash onset or worsening of local inflammatory signs) and general symptoms (vital signs, fever, rash, arthralgia, gastro-intestinal symptoms...) will be performed.
The number of MedDRA coded Adverse Events per patient
The presence/absence of abnormal laboratory results
Wound surface area
Wound surface area
Wound surface area
Wound surface area
Wound surface area
Wound surface area
Wound depth
Wound depth
Wound depth
Wound depth
Wound depth
Wound depth
Time to healing
The % of completely healed wounds
Classification of Staphylococcus isolates as MSSA or MRSA resistant
MSSA: Methicillin-susceptible Staphylococcus aureus MRSA: Methicillin-resistant Staphylococcus aureus
What is reported is a binary result: isolates are classified as either "MSSA" or "MRSA"
Classification of Staphylococcus isolates as MSSA or MRSA resistant
MSSA: Methicillin-susceptible Staphylococcus aureus MRSA: Methicillin-resistant Staphylococcus aureus
What is reported is a binary result: isolates are classified as either "MSSA" or "MRSA"
Classification of Staphylococcus isolates as MSSA or MRSA resistant
MSSA: Methicillin-susceptible Staphylococcus aureus MRSA: Methicillin-resistant Staphylococcus aureus
What is reported is a binary result: isolates are classified as either "MSSA" or "MRSA"
Classification of Staphylococcus isolates according to clonal complexes (virulence classification)
Classification of Staphylococcus isolates according to clonal complexes (virulence classification)
Classification of Staphylococcus isolates according to clonal complexes (virulence classification)
Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant
Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant
Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant
Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant
Wound microbiota: OTU richness
OTU: Operational Taxonomic Unit
Wound microbiota: OTU richness
OTU: Operational Taxonomic Unit
Wound microbiota: OTU richness
OTU: Operational Taxonomic Unit
Wound microbiota: OTU richness
OTU: Operational Taxonomic Unit
Wound microbiota: Shannon's Diversity
Wound microbiota: Shannon's Diversity
Wound microbiota: Shannon's Diversity
Wound microbiota: Shannon's Diversity
Wound microbiota: Functional richness
Wound microbiota: Functional richness
Wound microbiota: Functional richness
Wound microbiota: Functional richness
Wound microbiota: Functional diversity
Wound microbiota: Functional diversity
Wound microbiota: Functional diversity
Wound microbiota: Functional diversity
Wound microbiota: the relative abundance of Staphylococcus relative to other bacteria in the wound
Wound microbiota: the relative abundance of Staphylococcus relative to other bacteria in the wound
Wound microbiota: the relative abundance of Staphylococcus relative to other bacteria in the wound
Wound microbiota: the relative abundance of Staphylococcus relative to other bacteria in the wound
Wound microbiota: the number of Staphylococcus strains in a wound
Wound microbiota: the number of Staphylococcus strains in a wound
Wound microbiota: the number of Staphylococcus strains in a wound
Wound microbiota: the number of Staphylococcus strains in a wound
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other bacteria in the wound
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other bacteria in the wound
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other bacteria in the wound
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other bacteria in the wound
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other Staphylococcus in the wound
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other Staphylococcus in the wound
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other Staphylococcus in the wound
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other Staphylococcus in the wound
Wound microbiota: ordination scores on each of two principal components extracted from UniFrac distances between all bacterial samples taken during the study
Wound microbiota: ordination scores on each of two principal components extracted from UniFrac distances between all bacterial samples taken during the study
Wound microbiota: ordination scores on each of two principal components extracted from UniFrac distances between all bacterial samples taken during the study
Wound microbiota: ordination scores on each of two principal components extracted from UniFrac distances between all bacterial samples taken during the study
The presence/absence of anti-phage antibodies in plasma samples
The presence/absence of anti-phage antibodies in plasma samples
The presence/absence of anti-phage antibodies in plasma samples
The presence/absence of anti-phage antibodies in plasma samples
Full Information
NCT ID
NCT02664740
First Posted
January 19, 2016
Last Updated
February 2, 2022
Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
Pherecydes Pharma
1. Study Identification
Unique Protocol Identification Number
NCT02664740
Brief Title
Standard Treatment Associated With Phage Therapy Versus Placebo for Diabetic Foot Ulcers Infected by S. Aureus
Acronym
PhagoPied
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
Pherecydes Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
E. To describe in the two study arms changes in wound microbiota 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.
F. To describe the production of anti-phage antibodies during the topical treatment: baseline and week 4, at modification of the first-line treatment or new antibiotic prescription (if any), and at week 12.
G. Creation of a biobank for future ancillary studies (including, but not limited to, cytokine levels and cellular immune responses): days 0 and week 4, as well as week 12.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Staphylococcal Infections
Keywords
Phage Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phage therapy
Arm Type
Experimental
Arm Description
Patients randomized to this arm will have phage therapy.
Intervention: Topical anti-Staphylococcus bacteriophage therapy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Topical anti-Staphylococcus bacteriophage therapy
Intervention Description
Patients randomized to the experimental arm will receive sterile compress dressings impregnated with a phage solution of 10^7 PFU/ml on days 0, 7 and 14 (unless the wound is already healed, i.e. phage solutions are not applied to healed wounds).
Intervention Type
Drug
Intervention Name(s)
Topical placebo corresponding to anti-Staphylococcus bacteriophage therapy
Intervention Description
Patients randomized to the placebo arm will receive sterile compress dressings impregnated with a placebo solution on days 0, 7 and 14 (unless the wound is already healed, i.e. placebo solutions are not applied to healed wounds).
Primary Outcome Measure Information:
Title
The relative reduction in wound surface area (%)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Immediate Safety
Description
The presence/absence of the following symptoms during each 1 hour observation periods following the application of each experimental wound dressing: local side effects (local rash onset or worsening of local inflammatory signs) and general symptoms (vital signs, fever, rash, arthralgia, gastro-intestinal symptoms...) will be performed.
Time Frame
Day 0, 1 hour after application of experimental dressing
Title
Immediate Safety
Description
The presence/absence of the following symptoms during each 1 hour observation periods following the application of each experimental wound dressing: local side effects (local rash onset or worsening of local inflammatory signs) and general symptoms (vital signs, fever, rash, arthralgia, gastro-intestinal symptoms...) will be performed.
Time Frame
Day 7, 1 hour after application of experimental dressing
Title
Immediate Safety
Description
The presence/absence of the following symptoms during each 1 hour observation periods following the application of each experimental wound dressing: local side effects (local rash onset or worsening of local inflammatory signs) and general symptoms (vital signs, fever, rash, arthralgia, gastro-intestinal symptoms...) will be performed.
Time Frame
Day 14, 1 hour after application of experimental dressing
Title
The number of MedDRA coded Adverse Events per patient
Time Frame
throughout the study; 12 weeks
Title
The presence/absence of abnormal laboratory results
Time Frame
throughout the study; 12 weeks
Title
Wound surface area
Time Frame
2 weeks
Title
Wound surface area
Time Frame
4 weeks
Title
Wound surface area
Time Frame
6 weeks
Title
Wound surface area
Time Frame
8 weeks
Title
Wound surface area
Time Frame
10 weeks
Title
Wound surface area
Time Frame
12 weeks
Title
Wound depth
Time Frame
2 weeks
Title
Wound depth
Time Frame
4 weeks
Title
Wound depth
Time Frame
6 weeks
Title
Wound depth
Time Frame
8 weeks
Title
Wound depth
Time Frame
10 weeks
Title
Wound depth
Time Frame
12 weeks
Title
Time to healing
Time Frame
censored at 12 weeks
Title
The % of completely healed wounds
Time Frame
12 weeks
Title
Classification of Staphylococcus isolates as MSSA or MRSA resistant
Description
MSSA: Methicillin-susceptible Staphylococcus aureus MRSA: Methicillin-resistant Staphylococcus aureus
What is reported is a binary result: isolates are classified as either "MSSA" or "MRSA"
Time Frame
4 weeks
Title
Classification of Staphylococcus isolates as MSSA or MRSA resistant
Description
MSSA: Methicillin-susceptible Staphylococcus aureus MRSA: Methicillin-resistant Staphylococcus aureus
What is reported is a binary result: isolates are classified as either "MSSA" or "MRSA"
Time Frame
at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Title
Classification of Staphylococcus isolates as MSSA or MRSA resistant
Description
MSSA: Methicillin-susceptible Staphylococcus aureus MRSA: Methicillin-resistant Staphylococcus aureus
What is reported is a binary result: isolates are classified as either "MSSA" or "MRSA"
Time Frame
at week 12 if the wound is still not healed
Title
Classification of Staphylococcus isolates according to clonal complexes (virulence classification)
Time Frame
4 weeks
Title
Classification of Staphylococcus isolates according to clonal complexes (virulence classification)
Time Frame
at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Title
Classification of Staphylococcus isolates according to clonal complexes (virulence classification)
Time Frame
at week 12 if the wound is still not healed
Title
Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant
Time Frame
week 0
Title
Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant
Time Frame
week 4
Title
Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant
Time Frame
at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Title
Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant
Time Frame
at week 12 if the wound is still not healed
Title
Wound microbiota: OTU richness
Description
OTU: Operational Taxonomic Unit
Time Frame
week 0
Title
Wound microbiota: OTU richness
Description
OTU: Operational Taxonomic Unit
Time Frame
week 4
Title
Wound microbiota: OTU richness
Description
OTU: Operational Taxonomic Unit
Time Frame
at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Title
Wound microbiota: OTU richness
Description
OTU: Operational Taxonomic Unit
Time Frame
at week 12 if the wound is still not healed
Title
Wound microbiota: Shannon's Diversity
Time Frame
week 0
Title
Wound microbiota: Shannon's Diversity
Time Frame
week 4
Title
Wound microbiota: Shannon's Diversity
Time Frame
at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Title
Wound microbiota: Shannon's Diversity
Time Frame
at week 12 if the wound is still not healed
Title
Wound microbiota: Functional richness
Time Frame
week 0
Title
Wound microbiota: Functional richness
Time Frame
week 4
Title
Wound microbiota: Functional richness
Time Frame
at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Title
Wound microbiota: Functional richness
Time Frame
at week 12 if the wound is still not healed
Title
Wound microbiota: Functional diversity
Time Frame
week 0
Title
Wound microbiota: Functional diversity
Time Frame
week 4
Title
Wound microbiota: Functional diversity
Time Frame
at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Title
Wound microbiota: Functional diversity
Time Frame
at week 12 if the wound is still not healed
Title
Wound microbiota: the relative abundance of Staphylococcus relative to other bacteria in the wound
Time Frame
week 0
Title
Wound microbiota: the relative abundance of Staphylococcus relative to other bacteria in the wound
Time Frame
week 4
Title
Wound microbiota: the relative abundance of Staphylococcus relative to other bacteria in the wound
Time Frame
at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Title
Wound microbiota: the relative abundance of Staphylococcus relative to other bacteria in the wound
Time Frame
at week 12 if the wound is still not healed
Title
Wound microbiota: the number of Staphylococcus strains in a wound
Time Frame
week 0
Title
Wound microbiota: the number of Staphylococcus strains in a wound
Time Frame
week 4
Title
Wound microbiota: the number of Staphylococcus strains in a wound
Time Frame
at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Title
Wound microbiota: the number of Staphylococcus strains in a wound
Time Frame
at week 12 if the wound is still not healed
Title
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other bacteria in the wound
Time Frame
week 0
Title
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other bacteria in the wound
Time Frame
week 4
Title
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other bacteria in the wound
Time Frame
at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Title
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other bacteria in the wound
Time Frame
at week 12 if the wound is still not healed
Title
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other Staphylococcus in the wound
Time Frame
week 0
Title
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other Staphylococcus in the wound
Time Frame
week 4
Title
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other Staphylococcus in the wound
Time Frame
at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Title
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other Staphylococcus in the wound
Time Frame
at week 12 if the wound is still not healed
Title
Wound microbiota: ordination scores on each of two principal components extracted from UniFrac distances between all bacterial samples taken during the study
Time Frame
week 0
Title
Wound microbiota: ordination scores on each of two principal components extracted from UniFrac distances between all bacterial samples taken during the study
Time Frame
week 4
Title
Wound microbiota: ordination scores on each of two principal components extracted from UniFrac distances between all bacterial samples taken during the study
Time Frame
at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Title
Wound microbiota: ordination scores on each of two principal components extracted from UniFrac distances between all bacterial samples taken during the study
Time Frame
at week 12 if the wound is still not healed
Title
The presence/absence of anti-phage antibodies in plasma samples
Time Frame
week 0
Title
The presence/absence of anti-phage antibodies in plasma samples
Time Frame
week 4
Title
The presence/absence of anti-phage antibodies in plasma samples
Time Frame
at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Title
The presence/absence of anti-phage antibodies in plasma samples
Time Frame
at week 12 if the wound is still not healed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 target wound is classified as P (1 or 2), E (1-30 cm^2), D (2), I (2) and S (1 or 2) according to the PEDIS classification
Participant final 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 target wound is classified as P (1 or 2), E (1-30 cm^2), D (2), I (2) and S (1 or 2) according to the PEDIS classification
The patient's wound is mono-infected with Staphylococcus aureus (MRSA or MSSA)
Participant pre-exclusion criteria:
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
Participant final exclusion criteria:
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 who have received antibiotics within the 7 days preceding inclusion
Patients with diabetic foot wounds associated with clinical or radiographic signs of arthritis or osteomyelitis*
Patients with diabetic foot wounds associated with critical limb ischemia according to P = grade 3 in the PEDIS classification
Patients whose wound is infected by a pathogen other than S. aureus (includes multi-infections) according to bacteriological sampling performed at the pre-inclusion visit
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Albert Sotto, MD, PhD
Phone
+33.(0)6.09.56.66.55
Email
albert.sotto@chu-nimes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Carey Suehs, PhD
Phone
+33.(0)4.66.68.67.88
Email
carey.suehs@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Sotto, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Bordeaux - Hôpital Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Dupon, MD, PhD
Facility Name
CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
City
Le Grau du Roi
ZIP/Postal Code
30240
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Schuldiner, MD
Facility Name
CHU de Nantes - Hôtel Dieu
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Boutoille, MD, PhD
Facility Name
APHP - Groupe Hospitalier Pitié-Salpetrière
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnès Hartemann, MD, PhD
Facility Name
APHP - Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-François Gautier, MD,PhD
Facility Name
CHRU de Toulouse - Hôpital de Rangueil
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Martini, MD
Facility Name
CH de Tourcoing
City
Tourcoing
ZIP/Postal Code
59200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Senneville, MD, PhD
Facility Name
Institut Robert Merle d'Aubigné
City
Valenton
ZIP/Postal Code
94460
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gérard Chiesa, MD
Facility Name
CH Intercommunal de Villeneuve-Saint-Georges
City
Villeneuve-Saint-Georges
ZIP/Postal Code
94195
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Patey, MD
12. IPD Sharing Statement
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Standard Treatment Associated With Phage Therapy Versus Placebo for Diabetic Foot Ulcers Infected by S. Aureus
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