Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
2,348
Countries
4
Sites
72
Staphylococcus aureus bacteremia
To examine the effect on all-cause mortality at 90 days of a range of interventions in patients with SAB
Key facts
- Sponsor
- University Medical Center Utrecht
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 26 Oct 2023 → ongoing
- Decision date (initial)
- 2026-01-08
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- ZonMW
External identifiers
- EU CT number
- 2023-503582-35-00
- ClinicalTrials.gov
- NCT05137119
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
To examine the effect on all-cause mortality at 90 days of a range of interventions in patients with SAB
Secondary objectives 1
- Examining the effect of a range of interventions on several secondary endpoints including mortality, hospital length of stay, treatment failure, treatment complications, and healthcare costs.
Conditions and MedDRA coding
Staphylococcus aureus bacteremia
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Staphylococcus aureus complex grown from ≥1 blood culture
- Admitted to a participating hospital at the time of eligibility assessment (OR if patient has died, they were admitted to this site anytime from the time of blood culture collection until the time of eligibility assessment)
Exclusion criteria 8
- Time of anticipated platform entry is greater than 72 hours post collection of the index blood culture
- Polymicrobial bacteraemia, defined as more than one organism (at species level) in the index blood cultures OR in any subsequent blood culture reported between the collection of the index blood culture and platform eligibility assessment, excluding those organisms judged to be contaminants by either the microbiology laboratory or treating clinician
- Known previous participation in the randomised SNAP platform
- Known positive blood culture for S. aureus (of the same silo: PSSA, MSSA or MRSA) between 72 hours and 180 days prior to the time of eligibility assessment
- Treating team deems enrolment in the study is not in the best interest of the patient
- Treating team believes that death is imminent and inevitable
- Patient is for end-of-life care and antibiotic treatment is considered not appropriate
- Patient has died since the collection of the index blood culture
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- all-cause mortality at 90 days after platform entry
Secondary endpoints 15
- All-cause mortality at 14, 28 and 42 days after platform entry
- Duration of survival censored at 90 days after platform entry
- Length of stay of acute index inpatient hospitalisation for those surviving until discharge from acute inpatient facilities (excluding HITH/COPAT/OPAT/rehab), measured from platform entry to discharge from acute inpatient facilities, truncated at 90 days after platform entry.
- Length of stay of total index hospitalisation for those surviving until hospital discharge (including HITH/COPAT/OPAT/rehab), measured from platform entry to discharge from total index hospitalisation, truncated at 90 days after platform entry.
- Time to being discharged alive from the total index hospitalisation (including HITH/COPAT/OPAT/rehab), measured from platform entry to discharge from total index hospitalisation, truncated at 90 days after platform entry (and all deaths within 90 days will be considered ’90 days’).
- Microbiological treatment failure defined as positive sterile site culture for S. aureus [of the same silo as the index isolate] between 14 and 90 days after platform entry). A sterile site means any sites deep to the skin and skin structures, including deep visceral and musculoskeletal abscesses that have been obtained in a sterile manner.
- Diagnosis of new foci between 14 and 90 days after platform entry. The presence of new foci will be determined by the site investigator and can incorporate clinical, radiological, microbiological and pathological findings.
- C. difficile diarrhoea as determined by a clinical laboratory in the 90 days following platform entry for participants ≥2 years of age. This means a stool submitted to a clinical laboratory has tested positive for C. difficile toxin or toxin gene.
- Serious adverse reactions (SARs) in the 90 days following platform entry.
- Health economic costs as detailed in the health economics appendix
- Proportion of participants who have returned to their usual level of function at day 90 as determined by whether the modified functional bloodstream infection score (FBIS) remained the same or improved between baseline and 90 days after platform entry Baseline=best within the 4 weeks prior to platform entry
- Desirability of outcome ranking 1 (modified Antibiotic Resistance Leadership Group version) at 90 days after platform entry
- Desirability of outcome ranking 2 (SNAP version) at 90 days after platform entry
- Total number of antibiotic days (IV and/or oral/enteral) in the 90 days following platform entry.
- Days alive and free of antibiotics in the 90 days following platform entry.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 15
SUB05076MIG · Substance
- Active substance
- Vancomycin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 6 g gram(s)
- Max total dose
- 540 g gram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13038MIG · Substance
- Active substance
- Benzylpenicillin Sodium
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 24 g gram(s)
- Max total dose
- 2160 g gram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07379MIG · Substance
- Active substance
- Cefazolin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 8 g gram(s)
- Max total dose
- 720 g gram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06393MIG · Substance
- Active substance
- Doxycycline
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 18000 mg milligram(s)
- Max treatment duration
- 90 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13477MIG · Substance
- Active substance
- Co-Trimoxazole
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 3840 mg milligram(s)
- Max total dose
- 345600 mg milligram(s)
- Max treatment duration
- 90 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06665MIG · Substance
- Active substance
- Clindamycin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1800 mg milligram(s)
- Max total dose
- 9 g gram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06910MIG · Substance
- Active substance
- Daptomycin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 10 mg/kg milligram(s)/kilogram
- Max total dose
- 90 g gram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06165MIG · Substance
- Active substance
- Cefalexin
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 4000 mg milligram(s)
- Max total dose
- 360000 mg milligram(s)
- Max treatment duration
- 90 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07673MIG · Substance
- Active substance
- Flucloxacillin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 12 g gram(s)
- Max total dose
- 1080 g gram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01342MIG · Substance
- Active substance
- Clindamycin Hydrochloride
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 1800 mg milligram(s)
- Max total dose
- 162000 mg milligram(s)
- Max treatment duration
- 90 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10309MIG · Substance
- Active substance
- Rifampicin
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 81000 mg milligram(s)
- Max treatment duration
- 90 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05481MIG · Substance
- Active substance
- Amoxicillin
- Pharmaceutical form
- DISPERSIBLE TABLET
- Route of administration
- ORAL
- Max daily dose
- 3000 mg milligram(s)
- Max total dose
- 270000 mg milligram(s)
- Max treatment duration
- 90 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08471MIG · Substance
- Active substance
- Levofloxacin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 90000 mg milligram(s)
- Max treatment duration
- 90 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08520MIG · Substance
- Active substance
- Linezolid
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 108000 mg milligram(s)
- Max treatment duration
- 90 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09086MIG · Substance
- Active substance
- Moxifloxacin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 36000 mg milligram(s)
- Max treatment duration
- 90 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Medical Center Utrecht
- Sponsor organisation
- University Medical Center Utrecht
- Address
- Heidelberglaan 100
- City
- Utrecht
- Postcode
- 3584 CX
- Country
- Netherlands
Scientific contact point
- Organisation
- University Medical Center Utrecht
- Contact name
- Marjolein Hensgens
Public contact point
- Organisation
- University Medical Center Utrecht
- Contact name
- Marc Bonten
Locations
4 EU/EEA countries · 72 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 1,000 | 32 |
| Germany | Ongoing, recruiting | 500 | 20 |
| Netherlands | Ongoing, recruiting | 648 | 12 |
| Sweden | Ongoing, recruiting | 200 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
CHU de Montpellier
Infectious Diseases, 39 Avenue Charles Flahaut, 34295, Montpellier Cedex 05
CHU de Bordeaux, Hôpital Pellegrin
Infectious Diseases, Place Amélie Raba Lèon, Department of Infectious and Tropical Diseases, Bordeaux
Centre Hospitalier Universitaire De Toulouse
Infectious Diseases, 9 Place Lange, 31300, Toulouse
CHU Nantes
Infectious Diseases, 5, allée de l’Ile Gloriette, Nantes
CHU Caen Normandie
Infectious Diseases, Côte de Nacre, Service de Maladies Infectieuses, Caen
Centre Hospitalier Intercommunal De Cornouaille
Infectious Diseases, 14 Avenue Yves Thepot, Bp 31757, Quimper Cedex
Hôpital Saint-Louis
Infectious Diseases, 1 Av. Claude Vellefaux, 75010, Paris
APHP - Hôpital Universitaire Pitié-Salpêtrière
Infectious Diseases, 47-83 Boulevard de l'hôpital, 75013, PARIS
Centre Hospitalier Regional D'Angers
Infectious Diseases, 4 Rue Larrey, 49100, Angers
Centre Hospitalier De Niort
[email protected], 40 Avenue Charles De Gaulle, 79000, Niort
Centre Hospitalier Le Mans
Infectious Diseases, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Hospital Kremlin-Bicêtre Ap-Hp
Infectious Diseases, 78, Rue du Général Leclerc, Le Kremlin-Bicêtre
CHRU Jean Minjoz
Infectious Diseases, 3 Boulevard Alexandre Fleming, 25030, Besançon
CHU Guadeloupe
Infectious Diseases, D106 Les Abymes, 97139, Les Abymes
CHU Limoges
Infectious Diseases, 8 avenue Dominique Larrey, 87000, Limoges
CHU Caremeau
Infectious Diseases, 4 Rue du Professeur Robert Debré, 30900, Nîmes
Hôpital Lariboisière - APHP
Infectious Diseases, 2 Rue Ambroise Paré, 75010, Paris
CH Pau
Infectious Diseases, 4 Bd Hauterive, France, Pau
Centre Hospitalier de la Côte Basque
Infectious Diseases, 13 avenue Interne Jacques LOËB, 64100, Bayonne
Centre Hospitalier De Perpignan
Infectious Diseases, 20 Avenue Du Languedoc, Cs 49954, Perpignan Cedex
Hopital de Hautepierre Strasbourg
Infectious Diseases, 1 Place de l'Hopital, 67000, Strasbourg
Hospital Raymond Poincare
Infectious Diseases, 104 boulevard Raymond-Poincaré, 92380, Garches
CHU De Martinique
Infectious Diseases, P. O. Box 90632, 97261, Fort De France Cedex
Hôpital l'Archet 1
Infectious Diseases, CHU NIce, 151 route de Saint-Antoine de Ginestière, Nice
Pontchaillou University Hospitalier
Infectious Diseases, 4 Rue Henrie LE GUILLOUX, Infectious Diseases and ICU, Rennes
Hopital Saint Antoine
Infectious Diseases, 184 Rue du Faubourg Saint-Antoine, 75012, paris
CHRU Tours Hopital Bretonneau
Infectious Diseases, 2 Tonnelle boulevard, 37000, Tours
CHU De Dijon
Infectious Diseases, 14 rue Gaffarel, Department of Infectious Diseases, Dijon
Centre Hospitalier Universitaire Grenoble Alpes
Infectious Diseases, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
CH Périgueux
Infectious Diseases, 80 Av. Georges Pompidou, 24000, Périgueux
Hôpital d’Instruction des Armées Laveran
Infectious Diseases, 34 Bd Lavéran, 13013, Marseille
APHP Bichat-Claude Bernard
Infectious Diseases, 46 rue Henri Huchard, Department of Infectious and Tropical Diseases, Paris
Universitaetsklinikum Augsburg
Internal Medicine, Stenglinstrasse 2, Kriegshaber, Augsburg
Universitaetsklinikum Schleswig-Holstein AöR
Internal medicine, Schittenhelmstrasse 12, Brunswik, Kiel
Otto Von Guericke Universitaet Magdeburg
Institute for Medical Microbiology and Hospital Hygiene, Leipziger Strasse 44, Leipziger Str., Magdeburg
Universitaetsklinikum Jena KöR
Institute for Infectious Diseases and Infection Control, Am Klinikum 1, Lobeda, Jena
University Hospital Cologne AöR
Clinic I of Internal Medicine, Kerpener Strasse 62, Lindenthal, Cologne
Carl Von Ossietzky Universitaet Oldenburg
Anesthesiology, Intensive Care Medicine, Emergency Care, Pain Therapy, Ammerlaender Heerstrasse 114-118, Wechloy, Oldenburg
Technische Universitaet Dresden
Infectious diseases, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Wuerzburg AöR
Infectious diseases, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Heidelberg AöR
Internal Medicine and Infectious Diseases, Im Neuenheimer Feld 324, Neuenheim, Heidelberg
Universitaetsklinikum Giessen und Marburg GmbH
Internal Medicine, Klinikstrasse 33, 35392, Giessen
Charite Universitaetsmedizin Berlin KöR
Infectious diseases, Chariteplatz 1, Mitte, Berlin
Universitaetsklinikum Regensburg AöR
Emergency department and department of infectious diseases, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Ludwig Maximilian University Of Munich
Internal Clinic IV, Department for Infectious Diseases, Ziemssenstrasse 1a, Ludwigsvorstadt-Isarvorstadt, Munich
Klinikum St. Georg gGmbH
Infectious diseases, Delitzscher Strasse 141, Eutritzsch, Leipzig
Medical Center - University Of Freiburg
Internal Medicine, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Universitaetsmedizin Greifswald KöR
Institute for Hygiene and Environmental Medicine, Fleischmannstrasse 8, Noerdliche Muehlenvorstadt, Greifswald
Universitaetsklinikum Ulm AöR
Infectious Diseases, Albert-Einstein-Allee 23, Eselsberg, Ulm
Goethe University Frankfurt
Infectiology, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
University Medical Center Hamburg-Eppendorf
Internal Medicine, Infectiology, Martinistrasse 52, Eppendorf, Hamburg
Medizinische Hochschule Hannover
Department for Respiratory Medicine and Infectious Disease, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Ikazia Ziekenhuis
Internal Medicine, Montessoriweg 1, 3083 AN, Rotterdam
Stichting Martini Ziekenhuis
Infectious diseases, Van Swietenplein 1, 9728 NT, Groningen
Bernhoven B.V.
Internal medicine, Nistelrodeseweg 10, 5406 PT, Uden
University Medical Center Utrecht
Infectious diseases, Heidelberglaan 100, 3584 CX, Utrecht
Treant Ziekenhuis
Internal Medicine, Boermarkeweg 60, Netherlands, Emmen
Dijklander Ziekenhuis
Internal medicine, Maelsonstraat 3, 1624 NP, Hoorn Nh
Rijnstate Ziekenhuis Stichting
Internal medicine, Wagnerlaan 55, 6815 AD, Arnhem
Jeroen Bosch Ziekenhuis
Infectious diseases, Henri Dunantstraat 1, 5223 GZ, 's-Hertogenbosch
Stichting Radboud University Medical Center
Clinical Pharmacology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Maastricht University Medical Center
MMI, P Debyelaan 25, 6229HX, Maastricht
UMC Groningen
Internal Medicine, Hanzeplein 1, 9700RB, Groningen
Antonius ziekenhuis Sneek
Internal Medicine and Infectious diseases, Bolswarderbaan 1, 8601ZK, Sneek
Skaraborg Hospital-Vastra Gotalandsregionen
Infectious diseases, Lovangsvagen 1, 541 42, Skovde
Region Jaemtland Haerjedalen
Infectious diseases, Kyrkgatan 12, 831 50, Ostersund
Västmanlands sjukhus Västerås
Infectious diseases, Västmanlands sjukhus Västerås, 721 89, Västerås
Region Västerbotten
Infectious diseases, Köksvägen 11, 90737, Umea
Region Skane Helsingborg Hospital
Infectious diseases, Charlotte Yhlens Gata 10, Helsingborgs Maria, Helsingborg
Region Skane Skanes Universitetssjukhus
Infectious diseases, St. Johns, Fritz Bauers Gata 5, Malmo
Karolinska University Hospital
Infectious diseases, Halsovagen, Flemingsberg, Huddinge
Region Skane Skanes Universitetssjukhus
Infectious diseases, Entregatan 7, 222 42, Lund
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2025-02-24 | 2025-03-13 | |||
| Netherlands | 2023-10-26 | 2023-10-26 | |||
| Sweden | 2025-04-30 | 2025-06-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 84 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_SNAP country addendum 2023-503582-35-00_redacted | 9 |
| Protocol (for publication) | D1_Protocol_SNAP country addendum 2023-503582-35-00_TC | 9 |
| Protocol (for publication) | D1_Protocol_SNAP country addendum_2023-503582-35-00 | 7 |
| Protocol (for publication) | D1_Protocol_SNAP EU Region Specific Appendix_redacted | 4 |
| Protocol (for publication) | D1_Protocol_SNAP EU Region Specific Appendix_TC_redacted | 4 |
| Protocol (for publication) | D1_SNAP Country-Specific Substudies Appendix | 4 |
| Protocol (for publication) | D1_SNAP Country-Specific Substudies Appendix_TC | 4 |
| Protocol (for publication) | D5_SNAP Adjunctive Treatment Domain Specific Appendix_20232023-503582-35-00 | 2 |
| Protocol (for publication) | D5_SNAP Core Protocol_20232023-503582-35-00 | 2 |
| Protocol (for publication) | D5_SNAP EOS Domain-Specific Appendix_20232023-503582-35-00 | 2 |
| Protocol (for publication) | D5_SNAP Health Economics Appendix_20232023-503582-35-00 | 2 |
| Protocol (for publication) | D5_SNAP Microbiology Appendix_20232023-503582-35-00 | 2 |
| Protocol (for publication) | D5_SNAP MRSA Backbone Domain-Specific Appendix_20232023-503582-35-00 | 2 |
| Protocol (for publication) | D5_SNAP PSSA_MSSA Backbone Domain-Specific Appendix_20232023-503582-35-00 | 2 |
| Protocol (for publication) | D5_SNAP PWID Appendix_20232023-503582-35-00 | 2 |
| Protocol (for publication) | D5_SNAP Registry Appendix_20232023-503582-35-00 | 2 |
| Protocol (for publication) | D5_SNAP Statistical Appendix_20232023-503582-35-00 | 2 |
| Recruitment arrangements (for publication) | D1_Protocol_SNAP country addendum_2023-503582-35-00 | 5 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements_EN | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements_ENG_clean | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements_ENG_TC | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements_SE | 1 |
| Recruitment arrangements (for publication) | K1_recruitmentprocedure_NLD | 1 |
| Subject information and informed consent form (for publication) | L1_Patientforetradare_overenskommelse_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LAR_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LAR_TC_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF SNAPregistry_Betreuer_DE | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF SNAPregistry_DE | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF SNAPtrial_DE_Anhang | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FRA redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FRA_TC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LAR_FRA redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LAR_FRA_TC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Platform_SE_clean | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Partner_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Partner_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Partner_TC_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Registry | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Registry LAR_FRA redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Registry LAR_FRA_TC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Registry_FRA redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Registry_FRA_TC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Registry_TC | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Registry_Vertegenwoordiger | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Registry_Vertegenwoordiger_TC | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SUBSTUDIES adult | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SUBSTUDIES adult_TC | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TC_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TC_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Vertegenwoordiger_redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Vertegenwoordiger_TC_redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Registry_SE_clean | 1 |
| Subject information and informed consent form (for publication) | L2_Letter to treating physician_FRA | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_clinicalletter_NL | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_dischargeletter_NL | 1 |
| Subject information and informed consent form (for publication) | L2_other subject information_instructionswabs_substudy2 | 2 |
| Subject information and informed consent form (for publication) | L2_other subject information_instructionswabs_substudy2_track_change | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Shipping instruction_substudy2 | 1 |
| Subject information and informed consent form (for publication) | L2_Patient and medication pass | 2 |
| Subject information and informed consent form (for publication) | L2_Patient facing document_clinical letter_SE | 1 |
| Subject information and informed consent form (for publication) | L2_Patient facing document_clinicalletter_DE | 1 |
| Subject information and informed consent form (for publication) | L2_Patient facing document_dischargeletter_DE | 1 |
| Subject information and informed consent form (for publication) | L2_Patient facing document_patient letter_SE | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Letter_FRA_clean | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Amoxicillin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Clindamycin oral | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Linezolid | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Rifampicin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC_Cefalexin | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC_Cotrimoxazole | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC_Doxycycline | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC_Levofloxacin | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC_Moxifloxacin | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Benzylpenicillin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Cefazolin | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Clindamycin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Daptomycin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Flucloxacillin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Vancomycin_ | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NLD_2023-503582-35-00 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_FR_2023-503582-35-00 | NA |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_SE_2023-503582-35-00 | 1 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-04 | Netherlands | Acceptable with conditions 2023-07-31
|
2023-08-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-21 | Netherlands | Acceptable 2023-10-04
|
2023-10-05 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-04-04 | 2024-07-15 | ||
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-04-25 | Acceptable 2023-10-04
|
2024-07-08 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-08-03 | Netherlands | No conclusion 2024-10-07
|
2024-10-15 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-02-10 | No conclusion | 2025-03-21 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-04-07 | Netherlands | No conclusion 2025-05-26
|
2025-06-10 |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2025-09-02 | 2026-01-08 | ||
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-01-23 | Netherlands | Acceptable 2026-04-28
|
2026-04-28 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-06 | Acceptable 2026-04-28
|
2026-05-06 |