Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
64
Countries
1
Sites
2
Periprosthetic hip joint infection Periprosthetic knee joint infection
A prospective comparative study of antibiotic treatment regimens for PJI guided by MIC or MBEC combined with MIC, and how it affects infection resolution, drug tolerability and relapse strain resistance patterns
Key facts
- Sponsor
- Vaestra Goetalandsregionen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Decision date (initial)
- 2024-10-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Swedish Government (ALFGBG-965217) · Swedish Research Counsil
External identifiers
- EU CT number
- 2024-518350-17-00
- EudraCT number
- 2020-003444-80
- ClinicalTrials.gov
- NCT04488458
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
A prospective comparative study of antibiotic treatment regimens for PJI guided by MIC or MBEC combined with MIC, and how it affects infection resolution, drug
tolerability and relapse strain resistance patterns
Secondary objectives 1
- To determine the virulence properties (e.g. biofilm formation ability, biofilm antimicrobial resistance, and production of toxins) of clinical strains of Staphylococcus spp. isolated from PJI.
Conditions and MedDRA coding
Periprosthetic hip joint infection Periprosthetic knee joint infection
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- First-time PJI in hip or knee according to Musculoskeletal Infection Society (MSIS) definitions; first DAIR (debridement, antibiotics and implant retention); mono-microbial staphylococcal infection; 14 days of intravenous treatment with either cloxacillin or vancomycin; standardized administration of local antibiotics.
Exclusion criteria 1
- Allergy/previous toxic event/unacceptable drug interaction to most effective antibiotic combination according to either MIC or MBEC; severe drug interactions to MBEC-guided compound. Pregnancy and women of childbearing potential (WOCBP).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportions of antimicrobial regimens other than 1st-line treatment that will be administered after the guidance of MIC-testing versus MIC- and MBEC-testing combined. [6 weeks]
Secondary endpoints 10
- Repeat procedure, relapse or reinfection [12 months]
- Oxford Hip Score/Oxford Knee Score [12 months]
- EQ-5D: Generic health status patient-reported outcome measure [12 months]
- Time to revision [12 months]
- Inpatient care: Resource consumption measure (days) [Up to 12 months]
- Outpatient visits: Resource consumption measure, number of visits, type of visits [Up to 12 months]
- Discharge destination: Resource consumption measure [Up to 12 months]
- Heath care costs: Compound measure using data from outcome 6-8 (currency EUR) [Time Frame: Up to 12 months]
- Development of additional antimicrobial resistance of the relapse causative strain [12 months]
- Correlation between the virulence properties of the causative bacteria and patient outcome (infection resolution versus recurrent infection) [12 months]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
SCP1166649 · ATC
- Active substance
- Bromhexine Hydrochloride
- Route of administration
- ORAL
- Max daily dose
- 2400 mg milligram(s)
- Max total dose
- 101 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01EE01 — SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1004780 · ATC
- Active substance
- Clindamycin Hydrochloride
- Route of administration
- ORAL
- Max daily dose
- 1800 mg milligram(s)
- Max total dose
- 76 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01FF01 — CLINDAMYCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP146976 · ATC
- Active substance
- Fusidic Acid
- Substance synonyms
- FUCIDIC ACID
- Route of administration
- ORAL
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 63 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01XC01 — FUSIDIC ACID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP13835914 · ATC
- Active substance
- Linezolid
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 50 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01XX08 — LINEZOLID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 2
SCP135738 · ATC
- Active substance
- Rifampicin
- Substance synonyms
- RIFAMPIN
- Route of administration
- ORAL
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 38 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J04AB02 — RIFAMPICIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP111060923 · ATC
- Active substance
- Ofloxacin Hydrochloride
- Route of administration
- ORAL
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 63 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01MA12 — LEVOFLOXACIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vaestra Goetalandsregionen
- Sponsor organisation
- Vaestra Goetalandsregionen
- Address
- Regionens Hus
- City
- Vänersborg
- Postcode
- 462 80
- Country
- Sweden
Scientific contact point
- Organisation
- Vaestra Goetalandsregionen
- Contact name
- Ola Rolfson
Public contact point
- Organisation
- Vaestra Goetalandsregionen
- Contact name
- Ola Rolfson
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 64 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-518350-17_redacted | 02 |
| Recruitment arrangements (for publication) | _Placeholder_transitional | 1 |
| Subject information and informed consent form (for publication) | L1_Forsokspersonsinfo_samtycke_2024-518350-17_redacted | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Bactrim forte | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Dalacin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Fucidin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Rimactan | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Tavanic | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Zyvoxid | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-10 | Sweden | Acceptable 2024-10-23
|
2024-10-23 |