The DALBA-study Introduction of the antibiotic dalbavancin in orthopaedic surgery – an evaluation of: • Health economic costs • Patient-reported outcomes on quality of life • Local bone and soft tissue concentrations • Effect on the gut microbiome A randomised controlled study of dalbavancin versus standard antibiotic treatment of Gram-positive periprosthetic joint infections.

2025-522088-13-00 Protocol 32522 Therapeutic use (Phase IV) Ongoing, recruiting

Start 12 Dec 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol 32522

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 50
Countries 1
Sites 1

Periprosthetic joint infection

To perform a cost-utility analysis (CUA) in a randomized clinical trial including patients with knee, hip, or shoulder periprosthetic joint infections. Participants are randomized to receive either standard antibiotic therapy or dalbavancin. Health economic costs will be compared between the two treatment groups and as…

Key facts

Sponsor
Region Midtjylland
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
12 Dec 2025 → ongoing
Decision date (initial)
2025-10-02
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacoeconomic, Pharmacokinetic, Others

To perform a cost-utility analysis (CUA) in a randomized clinical trial including patients with knee, hip, or shoulder periprosthetic joint infections. Participants are randomized to receive either standard antibiotic therapy or dalbavancin. Health economic costs will be compared between the two treatment groups and assessed in relation to patients’ health-related quality of life. Economic data will be collected from Aarhus University Hospital and Statistics Denmark. Quality of life will be measured using patient-reported outcome measures (PROMs).

Secondary objectives 4

  1. To assess whether treatment with dalbavancin enables a higher level of physical activity compared to standard therapy, measured as daily activity using an activity tracker during the treatment period (6 or 12 weeks).
  2. To use microdialysis for determining dalbavancin concentrations in bone and subcutaneous tissue, compared with plasma samples, in a subgroup of non-infected participants (Group 3) undergoing elective knee arthroplasty.
  3. To identify and quantify the microbial diversity and functional characteristics of the gut through sequencing. Additionally, to investigate, using bioinformatics, the effect of dalbavancin treatment on the gut microbiome resistome compared to standard antibiotic treatment.
  4. To characterise local pathological and immunological conditions in periprosthetic joint infections through histological and molecular analyses of tissue collected during surgery.

Conditions and MedDRA coding

Periprosthetic joint infection

VersionLevelCodeTermSystem organ class
21.0 LLT 10021799 Infection and inflammatory reaction due to other internal orthopedic device implant and graft 10021881
21.1 PT 10059650 Implant site infection 100000004862

Study design 2 periods

#TitleAllocationBlindingRoles blindedArms
1 Group 1 + 2
The 40 trial participants with gram-positive prosthetic joint infection will be randomised into: Group 1: 20 participants undergoing surgical revision (one-stage revision) plus 6 weeks of antibiotic treatment. These participants will be further sub-randomised to receive either standard antibiotic therapy (Group 1A = 10 participants) or dalbavancin (Group 1B = 10 participants). Group 2: 20 participants undergoing surgical revision (DAIR procedure) plus 12 weeks of antibiotic treatment. These participants will be further sub-randomised to receive either standard antibiotic therapy (Group 2A = 10 participants) or dalbavancin (Group 2B = 10 participants).
 Randomised Controlled None
2 Group 3
Group 3 includes 10 healthy participants scheduled for elective knee prosthesis surgery at the Department of Orthopaedic Surgery, Aarhus University Hospital, receiving a single intravenous dose of prophylactic dalbavancin (1500 mg over 30 minutes). Using the microdialysis method, concentrations of dalbavancin will be measured from bone and subcutaneous tissue during the 8 hours following dalbavancin administration.
 2 None

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Signed consent forms.
  2. Age 18 years or older.
  3. Groups 1+2: Participants with suspected gram-positive PJI in the knee, hip, or shoulder requiring revision with either DAIR or one-stage surgery at the Department of Orthopaedic Surgery, Aarhus University Hospital.
  4. Group 3: Participants scheduled for elective knee replacement surgery at the Department of Orthopaedic Surgery, Aarhus University Hospital.

Exclusion criteria 4

  1. Allergy to gentamicin, ceftriaxone or glycopeptides (dalbavancin, vancomycin, teicoplanin).
  2. Periprosthetic joint infection in knee, hip, or shoulder caused by a gram-negative bacteria.
  3. Impaired renal function with eGFR<30.
  4. Pregnancy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Cost-utility analysis during antibiotic treatment (intention-to-treat): Absolute treatment costs during the acute treatment period of 6 or 12 weeks of antibiotics in the two treatment groups, assessed in relation to quality-adjusted life years (QALYs).

Secondary endpoints 5

  1. Cost-utility analysis after one-year of follow-up (per protocol): Long-term health economics and patient-experienced quality of life, incorporating long-term effects and any late complications or recurrence within the first year.
  2. Physical activity: Average daily activity during the treatment period (6 or 12 weeks), recorded using an activity tracker.
  3. Tissue concentration: Standard pharmacokinetic parameters (e.g., AUC/MIC, T>MIC, AUC, T½, Cmax, Tmax) in bone tissue, subcutaneous tissue, and plasma.
  4. Gut response: Gut microbiome diversity profile and resistome, including AMR genes.
  5. Immune response: Standard histological examination of HE stains with quantification of the infiltration of neutrophil granulocytes, macrophages, and lymphocytes. In addition, histological identification of specific genes and proteins involved in inflammatory and immune-regulatory pathways.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Dalbavancin

SCP107118764 · ATC

Active substance
Dalbavancin
Route of administration
INTRAVENOUS ADMINISTRATION
Max daily dose
1.5 g gram(s)
Max total dose
4.5 g gram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
J01XA04 — DALBAVANCIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Dalbavancin is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI). In this study it is used off-label for periprosthetic joint infections.

Comparator 13

Dicloxacillin

SCP139474 · ATC

Active substance
Dicloxacillin
Route of administration
ORAL USE
Max daily dose
4 g gram(s)
Max total dose
280 g gram(s)
Max treatment duration
10 Week(s)
Authorisation status
Authorised
ATC code
J01CF01 — DICLOXACILLIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Moxifloxacin Hydrochloride

SCP1150651 · ATC

Active substance
Moxifloxacin Hydrochloride
Route of administration
ORAL USE
Max daily dose
0.4 g gram(s)
Max total dose
28 g gram(s)
Max treatment duration
10 Week(s)
Authorisation status
Authorised
ATC code
J01MA14 — MOXIFLOXACIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Levofloxacin

SCP111060923 · ATC

Active substance
Levofloxacin
Substance synonyms
HR355
Route of administration
ORAL USE
Max daily dose
1 g gram(s)
Max total dose
70 g gram(s)
Max treatment duration
10 Week(s)
Authorisation status
Authorised
ATC code
J01MA12 — LEVOFLOXACIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fusidic Acid

SCP146976 · ATC

Active substance
Fusidic Acid
Substance synonyms
FUCIDIC ACID
Route of administration
ORAL USE
Max daily dose
1.5 g gram(s)
Max total dose
105 g gram(s)
Max treatment duration
10 Week(s)
Authorisation status
Authorised
ATC code
J01XC01 — FUSIDIC ACID
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Amoxicillin Sodium

SCP10330863 · ATC

Active substance
Amoxicillin Sodium
Route of administration
ORAL USE
Max daily dose
4 g gram(s)
Max total dose
280 g gram(s)
Max treatment duration
10 Week(s)
Authorisation status
Authorised
ATC code
J01CA04 — AMOXICILLIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Flucloxacillin Sodium

SCP107974864 · ATC

Active substance
Flucloxacillin Sodium
Route of administration
ORAL USE
Max daily dose
4 g gram(s)
Max total dose
280 g gram(s)
Max treatment duration
10 Week(s)
Authorisation status
Authorised
ATC code
J01CF05 — FLUCLOXACILLIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cloxacillin

SCP102640673 · ATC

Active substance
Cloxacillin
Route of administration
INTRAVENOUS ADMINISTRATION
Max daily dose
8 g gram(s)
Max total dose
112 g gram(s)
Max treatment duration
2 Week(s)
Authorisation status
Authorised
ATC code
J01CF02 — CLOXACILLIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Rifampicin

SCP125046563 · ATC

Active substance
Rifampicin
Substance synonyms
RIFAMPIN
Route of administration
ORAL USE
Max daily dose
0.9 g gram(s)
Max total dose
63 g gram(s)
Max treatment duration
10 Week(s)
Authorisation status
Authorised
ATC code
J04AB02 — RIFAMPICIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vancomycin

SCP121117533 · ATC

Active substance
Vancomycin
Substance synonyms
VANCOMYCINUM
Route of administration
INTRAVENOUS ADMINISTRATION
Max daily dose
60 mg/Kg milligram(s)/kilogram
Max total dose
840 mg/Kg milligram(s)/kilogram
Max treatment duration
2 Week(s)
Authorisation status
Authorised
ATC code
J01XA01 — VANCOMYCIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Benzylpenicillin Procaine

SCP104123707 · ATC

Active substance
Benzylpenicillin Procaine
Substance synonyms
PROCAINE BENZYLPENICILLIN, PENICILLIN G PROCAINE, PENICILLIN PROCAINE
Route of administration
INTRAVENOUS ADMINISTRATION
Max daily dose
4.8 g gram(s)
Max total dose
336 g gram(s)
Max treatment duration
2 Week(s)
Authorisation status
Authorised
ATC code
J01CE01 — BENZYLPENICILLIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Bromhexine Hydrochloride

SCP1166649 · ATC

Active substance
Bromhexine Hydrochloride
Route of administration
ORAL USE
Max daily dose
2.88 g gram(s)
Max total dose
201.6 g gram(s)
Max treatment duration
10 Week(s)
Authorisation status
Authorised
ATC code
J01EE01 — SULFAMETHOXAZOLE AND TRIMETHOPRIM
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Linezolid

SCP13835914 · ATC

Active substance
Linezolid
Route of administration
ORAL USE
Max daily dose
1.2 g gram(s)
Max total dose
84 g gram(s)
Max treatment duration
10 Week(s)
Authorisation status
Authorised
ATC code
J01XX08 — LINEZOLID
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Clindamycin Hydrochloride

SCP1004780 · ATC

Active substance
Clindamycin Hydrochloride
Route of administration
ORAL USE
Max daily dose
1.8 g gram(s)
Max total dose
126 g gram(s)
Max treatment duration
10 Week(s)
Authorisation status
Authorised
ATC code
J01FF01 — CLINDAMYCIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Auxiliary 2

Ceftriaxone Sodium

SCP107121969 · ATC

Active substance
Ceftriaxone Sodium
Route of administration
INTRAVENOUS ADMINISTRATION
Max daily dose
4 g gram(s)
Max total dose
21 g gram(s)
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
J01DD04 — CEFTRIAXONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Betamethasone Valerate

SCP12505097 · ATC

Active substance
Betamethasone Valerate
Substance synonyms
BETAMETHASONE 17-VALERATE
Route of administration
LOCAL USE
Max daily dose
650 mg milligram(s)
Max total dose
650 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J01GB03 — GENTAMICIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Midtjylland

59 Total trials 36 Recruiting 13 Ended
Academic / Non-commercial
Sponsor organisation
Region Midtjylland
Address
Palle Juul-Jensens Boulevard 99
City
Aarhus N
Postcode
8200
Country
Denmark

Scientific contact point

Organisation
Region Midtjylland
Contact name
Mats Bue

Public contact point

Organisation
Region Midtjylland
Contact name
Mats Bue

Third parties 4

OrganisationCity, countryDuties
Department of Veterinary and Animal Sciences
ORL-000015114
 1870 Frederiksberg C, Denmark Laboratory analysis
Aarhus Universitet
ORG-100028380
 Aarhus N, Denmark On site monitoring
Department of Plant and Environmental Sciences
ORL-000015115
 Frederiksberg C, Denmark Laboratory analysis
Department of Public Health
ORL-000015116
 Odense M, Denmark Data management

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ongoing, recruiting 50 1
Rest of world — 0 —

Investigational sites

Denmark

1 site · Ongoing, recruiting
Region Midtjylland
Orthopaedic Surgery, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2025-12-12 2026-01-01

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 33 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_protocol_DA_EUCT2025-522088-13-00 3
Protocol (for publication) D10_patient facing document_oxford-hip_DA 1
Protocol (for publication) D11_patient facing document_oxford-knee_DA 1
Protocol (for publication) D12_patient facing document_oxford-shoulder_DA 1
Protocol (for publication) D4_patient facing document_MMAS_DA 1
Protocol (for publication) D5_patient facing document_patientdiary_DA 1
Protocol (for publication) D6_patient facing document_PROMIS_10a_DA 1
Protocol (for publication) D7_patient facing document_EQ-5D-5L_EQ-VAS_DA 1
Protocol (for publication) D8_patient facing document_SF12_DA 1
Protocol (for publication) D9_patient facing document_transport_time_costs_DA 1
Recruitment arrangements (for publication) K1_patient recruitment procedure 3
Subject information and informed consent form (for publication) L1_informed consent form 1, Group 1 and 2 4
Subject information and informed consent form (for publication) L2_informed consent form 2 2
Subject information and informed consent form (for publication) L3_consent information 1
Subject information and informed consent form (for publication) L3_subject information sheet group1 and 2 4
Subject information and informed consent form (for publication) L4_subject information sheet group 3 3
Subject information and informed consent form (for publication) L5_informed consent form 1, Group 3 3
Summary of Product Characteristics (SmPC) (for publication) G1_SmPC_dalbavancin 1
Summary of Product Characteristics (SmPC) (for publication) H1_SmPC_amoxicillin 1
Summary of Product Characteristics (SmPC) (for publication) H10_SmPC_moxifloxacin 1
Summary of Product Characteristics (SmPC) (for publication) H11_SmPC_rifampicin 1
Summary of Product Characteristics (SmPC) (for publication) H12_SmPC_sulfametoxazol_trimethroprim 1
Summary of Product Characteristics (SmPC) (for publication) H13_SmPC_vancomycin 1
Summary of Product Characteristics (SmPC) (for publication) H2_SmPC_benzylpenicillin 1
Summary of Product Characteristics (SmPC) (for publication) H3_SmPC_clindamycin 1
Summary of Product Characteristics (SmPC) (for publication) H4_SmPC_cloxacillin 1
Summary of Product Characteristics (SmPC) (for publication) H5_SmPC_dicloxacillin 1
Summary of Product Characteristics (SmPC) (for publication) H6_SmPC_flucloxacillin 1
Summary of Product Characteristics (SmPC) (for publication) H7_SmPC_fucidin 1
Summary of Product Characteristics (SmPC) (for publication) H8_SmPC_levofloxacin 1
Summary of Product Characteristics (SmPC) (for publication) H9_SmPC_linezolid 1
Synopsis of the protocol (for publication) D2_ synopsis_DA_EUCT2025-522088-13-00 1
Synopsis of the protocol (for publication) D3_synopsis_ENG_EUCT2025-522088-13-00 1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-07-05 Denmark Acceptable
2025-09-19
 2025-10-02
2 NON SUBSTANTIAL MODIFICATION NSM-2 2025-12-05 Denmark Acceptable
2025-09-19
 2025-12-05