Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
1,100
Countries
1
Sites
13
Prosthetic Joint Infection
To investigate whether antibiotic impregnated bone graft (AIBG) decreases the risk of infection 2 years after hip arthroplasty, compared to controls treated with placebo impregnated bone graft.
Key facts
- Sponsor
- Region Oestergoetland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Musculoskeletal Diseases [C05], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04], Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11]
- Trial duration
- 18 Mar 2022 → ongoing
- Decision date (initial)
- 2024-03-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-510921-25-00
- EudraCT number
- 2021-001708-14
- ClinicalTrials.gov
- NCT05169229
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
To investigate whether antibiotic impregnated bone graft (AIBG) decreases the risk of infection 2 years after hip arthroplasty, compared to controls treated with placebo impregnated bone graft.
Secondary objectives 4
- To investigate differences between the two experimental groups in time to and reason for reoperation for any reason within 2 and 5 years • time and reason for implant revision due to any reason within 2 and 5 years.
- To investigate differences between the two experimental groups in time to and reason for implant revision due to any reason within 2 and 5 years
- To investigate differences between the two experimental groups in the type of microorganism and antibiotic susceptability pattern in cases with postoperative infection.
- To evaluate the safety of using antibiotic impregnated bone graft (AIBG) as infection prophylaxis in hip arthroplasty.
Conditions and MedDRA coding
Prosthetic Joint Infection
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Antibiotic Impregnated Bone Graft to reduce infection in hip replacement. The ABOGRAFT trial. A pragmatic, phase II, randomized, double-blind, placebo-controlled, multicenter drug trial.
|
Randomised Controlled | Double | [{"id":167919,"code":5,"name":"Carer"},{"id":167920,"code":1,"name":"Subject"},{"id":167918,"code":2,"name":"Investigator"},{"id":167921,"code":4,"name":"Analyst"}] | Placebo impregnated bone graft: Morselized bone graft impregnated with 8ml NaCl. Antibiotic impregnated bone graft: 8 ml of tobramycin (80mg/ml) are aspirated in a sterile syringe and used to dissolve 1g vancomycin powder from its ampule. The solution will be mixed with the morselized bone graft. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age ≥ 18 years
- Hip arthroplasty requiring bone graft
- Willing to provide informed consent
- For females of childbearing potential; a negative pregnancy test prior to reoperation
Exclusion criteria 7
- Ongoing prosthetic joint infection
- Known allergies and contraindications for the use of vancomycin or tobramycin
- Mental inability, reluctance, or language difficulties that according to investigator judgement, result in difficulty understanding the meaning of study participation
- Expected difficulties to complete 2-year follow-up
- Females of child bearing potential not using contraception
- Pregnant females
- Nursing females
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Reoperation due to infection or diagnosed PJI with bacteria that are sensitive to either vancomycin or tobramycin, in the same hip joint, within two years after hip arthroplasty
Secondary endpoints 5
- Time and cause for reoperation for any reason within 2 and 5 years
- Time and cause for implant revision due to any reason within 2 and 5 years
- Type of microbe and antibiotic resistance pattern for cases complicated with postoperative infection
- Differences between the two experimental groups regarding the frequencies of adverse events
- Differences between the two experimental groups regarding the rates of revision due to aseptic loosening
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SCP101105926 · ATC
- Active substance
- Tobramycin Sulfate
- Substance synonyms
- Tobramycin hemipentasulfate, TOBRAMYCIN SULPHATE
- Route of administration
- INTRAARTICULAR USE
- Max daily dose
- 1920 mg/ml milligram(s)/millilitre
- Max total dose
- 1920 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01GB01 — TOBRAMYCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP121117533 · ATC
- Active substance
- Vancomycin
- Substance synonyms
- VANCOMYCINUM
- Route of administration
- INTRAARTICULAR USE
- Max daily dose
- 3000 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB20722 · Substance
- Active substance
- Saline
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAARTICULAR USE
- Max daily dose
- 8 ml millilitre(s)
- Max total dose
- 8 ml millilitre(s)
- Max treatment duration
- 1 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
Region Oestergoetland
- Sponsor organisation
- Region Oestergoetland
- Address
- Universitetssjukhuset 1
- City
- Linkoping
- Postcode
- 581 85
- Country
- Sweden
Scientific contact point
- Organisation
- Region Oestergoetland
- Contact name
- Jörg Schilcher
Public contact point
- Organisation
- Region Oestergoetland
- Contact name
- Jörg Schilcher
Locations
1 EU/EEA country · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 1,100 | 13 |
| Rest of world | — | 0 | — |
Investigational sites
Sahlgrenska University Hospital-Vastra Gotalandsregionen
orthopedi, Goteborgsvagen 31, Fassberg, Molndal
Vaesterviks Sjukhus Region Kalmar Laen
othopedi, Ostra Kyrkogatan 48, 593 33, Vastervik
Region Oerebro Laen
orthopedi, Sodra Grev Rosengatan, 701 85, Orebro
Region Skane Skanes Universitetssjukhus
orthopedi, Entregatan 7, 222 42, Lund
Laenssjukhuset I Kalmar Region Kalmar Laen
orthopedi, Lasarettsvagen 8, Kalmar S:t Johannes, Kalmar
Region Skane Hassleholm Hospital
orthopedi, Esplanadgatan 19, 281 38, Hassleholm
Region Oestergoetland
Orthopedi, Universitetssjukhuset I, 58185, Linkoping
Lasarettet I Motala Region Ostergotland
orthopedi, Lasarettsgatan 37, 591 35, Motala
Danderyds Sjukhus AB
orthopedi, Morbygardsvagen 88, 182 88, Danderyd
Region Dalarna
orthopedi, Vasagatan 27, Falu Kristine, Falun
Vrinnevisjukhuset I Norrkoeping Region Oestergoetland
Orthopedi, S Borg, Gamla Ovagen 25, Norrkoping
Uppsala University Hospital
Orthopedi, Sjukhusvagen 85, 751 85, Uppsala
Region Skane Lasarettet Trelleborg
Ortopedi, Hedvagen 46, 231 52, Trelleborg
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 |
|---|---|---|---|---|---|
| Sweden | 2022-03-18 | 2022-04-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-510921-25-00 | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | L1-SIS and ICF_RCT and cohort | 3.4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC tobramycin | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Vancomycin | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN 2024-510921-25-00 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis SE 2024-510921-25-00 | 4 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-08 | Sweden | Acceptable 2024-03-18
|
2024-03-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-18 | Sweden | Acceptable 2025-09-03
|
2025-09-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-06 | Sweden | Acceptable | 2026-03-30 |