Bone or Joint InfectionPhase 2NCT03723551
Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus
A Phase 2 study testing Afabicin, Cefazolin and Vancomycin in people with Bone or Joint Infection, run by Debiopharm International SA at 19 sites in 3 countries.
Trial summary
This is a randomized, active-controlled, open-label study to assess the safety, tolerability and efficacy of Afabicin in the treatment of participants with bone or joint infection due to Staphylococcus aureus [both methicillin-susceptible S. aureus (MSSA) and methicillin-resistant S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone or Joint Infection
- What is being tested?
- Afabicin, Cefazolin and Vancomycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 19 sitesin 3 countries
- Study dates
- 20 Feb 2019to 23 Apr 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent and to comply with study procedures.
- Diagnosis of bone or joint infection which fulfils the following conditions: a) Infection is due to S. aureus (MSSA or MRSA) and/or CoNS only; and, b) Participants had received no more than 7 days of empiric antibiotics prior to initiating treatment with study drug unless the pathogen isolated was resistant to the administered empiric antibiotics; and, c) Biofilm is not considered to be yet established and/or has been mechanically eradicated; and, d) Infection is not associated with an ischiatic or a sacral osteomyelitis; and e) Infection can involve periosteal or soft tissue.
Who cannot join
- Presence of co-infection with non-staphylococcal bacteria at the affected joint or bone site, or in the blood.
- Participants at an increased risk of developing liver injury.
- Participants who have medical conditions that increase the risk of QT prolongation.
- Medical history within the previous 3 months of: myocardial infarction, unstable angina pectoris, coronary artery or cerebral revascularization procedure or stroke, ventricular tachycardia, multifocal ventricular ectopics requiring treatment, or any other clinically relevant symptomatic ventricular arrhythmias.
- Documented history of alcohol or drug abuse within the previous 12 months.
- For patients with DFO:
Show all 11Show fewer
- Severe peripheral arterial disease (PAD) requiring revascularization; however, patients with peripheral artery disease are eligible for inclusion, provided they have undergone successful revascularization or it has been deemed unnecessary by a vascular surgeon
- Necrotizing fasciitis or gangrene requiring complete lower extremity amputation (of all infected bone and soft tissue).
- Patients with Charcot foot (suspected neuro-osteoarthropathy according to Investigator's judgment).
- Need for digital amputation.
- Life expectancy of less than 1 year.
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
Ukraine9 sites
Dnipropetrovsk Regional Clinical Hospital
Dnipro, 49027
Regional Clinical Hospital under Ivano-Frankivsk Regional Council
Ivano-Frankivsk, 76008
Kharkiv Regional Clinical Traumatology Hospital
Kharkiv, 61176
Institute of Traumatology and Orthopedics
Kyiv, 01601
Kyiv Regional Clinical Hospital
Kyiv, 04107
Kyiv City Clinical Hospital #8 under the Executive Body of Kyiv City Council (Kyiv City State Administration)
Kyiv
Vinnytsya Regional Clinical Hospital
Vinnytsia, 21028
Lviv Regional Hospital of Veterans of Wars and Repressed after Yurii Lypa
Vynnyky, 79495
City Hospital #9 under Zaporizhia City Council
Zaporizhia, 69065
Georgia7 sites
Georgian Clinics JSC
Akhalts'ikhe, 0800
West Georgia Medical Center LLC
Kutaisi, 4600
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
Tbilisi, 0101
LEPL The First University Clinic of Tbilisi State Medical University
Tbilisi, 0141
Tbilisi State Medical University And Ingorokva High Medical Technology University Clinic LLC
Tbilisi, 0144
Academician Vakhtang Bochorishvili Clinic LTD
Tbilisi, 0160
Caucasus Medical Center LLC
Tbilisi, 0186
South Africa3 sites
Worthwhile Clinical Trials, Lakeview Hospital
Benoni, 1500
Clinical Research Unit, University of Pretoria
Pretoria, 0002
Global Clinical Trials (Pty) Ltd
Pretoria, 0157
About this study
Official title: Randomized Open-label Active-controlled Study to Assess the Safety, Tolerability, and Efficacy of Afabicin IV/Oral in the Treatment of Patients With Bone or Joint Infection Due to Staphylococcus
This is a randomized, active-controlled, open-label study to assess the safety, tolerability and efficacy of Afabicin in the treatment of participants with bone or joint infection due to Staphylococcus aureus [both methicillin-susceptible S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA)] and/or coagulase-negative staphylococci (CoNS) and to compare it to standard of care (SoC).
- Conditions
- Bone or Joint Infection
- Being tested
- Afabicin, Cefazolin, Vancomycin, Linezolid, Clindamycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfabicinDrug
Administered intravenously and orally.
CefazolinDrug
Administered intravenously.
VancomycinDrug
Administered intravenously.
LinezolidDrug
Administered intravenously and orally.
ClindamycinDrug
Administered intravenously and orally.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Afabicin: Cohort 1 | Experimental | Participants received afabicin intravenously (IV) at a dose of 160 milligrams (mg), twice daily (BID), followed by a switch to oral afabicin at a dose of 240 mg, BID, for 2-3 weeks. Receives: Drug: Afabicin |
| Part A: Afabicin: Cohort 2 | Experimental | Participants received afabicin IV at a dose of 160 mg, BID, followed by a switch to oral afabicin at a dose of 240 mg, BID, for 3-6 weeks. Receives: Drug: Afabicin |
| Part A: SoC: Cohort 1 | Active comparator | Participants with oxacillin-/methicillin-susceptible staphylococci were administered with either cefazolin or vancomycin or linezolid or clindamycin, IV or linezolid or clindamycin, orally; participants with oxacillin-/methicillin-resistant staphylococci were administered either vancomycin or clindamycin or linezolid, IV or linezolid or clindamycin, orally, as part of SoC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule. Receives: Drug: Cefazolin; Drug: Vancomycin; Drug: Linezolid; Drug: Clindamycin |
| Part A: SoC: Cohort 2 | Active comparator | Participants with oxacillin-/methicillin-susceptible staphylococci were administered with either cefazolin or vancomycin or linezolid or clindamycin, IV or linezolid or clindamycin, orally; participants with oxacillin-/methicillin-resistant staphylococci were administered either vancomycin or clindamycin or linezolid, IV or linezolid or clindamycin, orally, as part of SoC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule. Receives: Drug: Cefazolin; Drug: Vancomycin; Drug: Linezolid; Drug: Clindamycin |
| Part B: Afabicin: Cohort 1 | Experimental | Participants received afabicin IV at a dose of 55 mg, BID, followed by a switch to oral afabicin at a dose of 80 mg, BID, for 2-3 weeks. Receives: Drug: Afabicin |
| Part B: Afabicin: Cohort 2 | Experimental | Participants received afabicin IV at a dose of 55 mg, BID, followed by a switch to oral afabicin at a dose of 80 mg, BID, for 3-6 weeks. Receives: Drug: Afabicin |
| Part B: SoC: Cohort 1 | Active comparator | Participants with oxacillin-/methicillin-susceptible staphylococci were administered with either cefazolin or vancomycin or linezolid or clindamycin, IV or linezolid or clindamycin, orally; participants with oxacillin-/methicillin-resistant staphylococci were administered either vancomycin or clindamycin or linezolid, IV or linezolid or clindamycin, orally, as part of SoC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule. Receives: Drug: Cefazolin; Drug: Vancomycin; Drug: Linezolid; Drug: Clindamycin |
| Part B: SoC: Cohort 2 | Active comparator | Participants with oxacillin-/methicillin-susceptible staphylococci were administered with either cefazolin or vancomycin or linezolid or clindamycin, IV or linezolid or clindamycin, orally; participants with oxacillin-/methicillin-resistant staphylococci were administered either vancomycin or clindamycin or linezolid, IV or linezolid or clindamycin, orally, as part of SoC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule. Receives: Drug: Cefazolin; Drug: Vancomycin; Drug: Linezolid; Drug: Clindamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. TEAE is any undesirable event either not present prior to medical treatment or worsening (in intensity or frequency) following treatment. SAE is defined as any untoward medical occurrence that at any dose: results in death; is life-threatening (i.e., puts the patient at immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect, or is otherwise medically significant.
Measured: Up to Day 142
Number of Participants With Grade Shift From Baseline in Hematology Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.03
Laboratory abnormalities were graded according to NCI CTCAE v4.03. Grade 0 indicates a normal value; Grades 1-4 represent increasing severity of abnormalities outside the normal range. "High" and "Low" indicate values above and below the normal range, respectively. At baseline (last assessment prior to randomization), both "High, Grade 0" and "Low, Grade 0" indicate normal values and identify the direction of the subsequent post-baseline shift. Participants were evaluated separately for High and Low shifts. Participant could contribute to both analyses if shifts occurred in opposite directions at different assessments. These categories are not mutually exclusive; therefore, counts should not be summed across directions, as they may exceed the number of participants analyzed. Participant could not be classified as both High and Low at the same assessment. Only categories with at least one participant showing a shift were reported.
Measured: Up to Day 142
Number of Participants With Grade Shift From Baseline in Clinical Chemistry Parameters Based on NCI-CTCAE v4.03
Laboratory abnormalities were graded according to NCI CTCAE v4.03. Grade 0 indicates a normal value; Grades 1-4 represent increasing severity of abnormalities outside the normal range. "High" and "Low" indicate values above and below the normal range, respectively. At baseline (last assessment prior to randomization), both "High, Grade 0" and "Low, Grade 0" indicate normal values and identify the direction of the subsequent post-baseline shift. Participants were evaluated separately for High and Low shifts. Participant could contribute to both analyses if shifts occurred in opposite directions at different assessments. These categories are not mutually exclusive; therefore, counts should not be summed across directions, as they may exceed the number of participants analyzed. Participant could not be classified as both High and Low at the same assessment. Only categories with at least one participant showing a shift were reported.
Measured: Up to Day 142
Number of Participants With Grade Shift From Baseline in Electrolyte Parameters Based on NCI-CTCAE v4.03
Laboratory abnormalities were graded according to NCI CTCAE v4.03. Grade 0 indicates a normal value; Grades 1-4 represent increasing severity of abnormalities outside the normal range. "High" and "Low" indicate values above and below the normal range, respectively. At baseline (last assessment prior to randomization), both "High, Grade 0" and "Low, Grade 0" indicate normal values and identify the direction of the subsequent post-baseline shift. Participants were evaluated separately for High and Low shifts. Participant could contribute to both analyses if shifts occurred in opposite directions at different assessments. These categories are not mutually exclusive; therefore, counts should not be summed across directions, as they may exceed the number of participants analyzed. Participant could not be classified as both High and Low at the same assessment. Only categories with at least one participant showing a shift were reported.
Measured: Up to Day 142
Number of Participants With Grade Shift From Baseline in Coagulation Parameters Based on NCI-CTCAE v4.03
Laboratory abnormalities were graded according to NCI CTCAE v4.03. Grade 0 indicates a normal value; Grades 1-4 represent increasing severity of abnormalities outside the normal range. "High" and "Low" indicate values above and below the normal range, respectively. At baseline (last assessment prior to randomization), both "High, Grade 0" and "Low, Grade 0" indicate normal values and identify the direction of the subsequent post-baseline shift. Participants were evaluated separately for High and Low shifts. Participant could contribute to both analyses if shifts occurred in opposite directions at different assessments. These categories are not mutually exclusive; therefore, counts should not be summed across directions, as they may exceed the number of participants analyzed. Participant could not be classified as both High and Low at the same assessment. Only categories with at least one participant showing a shift were reported.
Measured: Up to Day 142
Number of Participants With Post-baseline Clinically Significant Urinalysis Abnormalities
Clinical significance of abnormalities in urinalysis was determined based on the investigator's discretion. Baseline is defined as the last assessment prior to the randomization.
Measured: Up to Day 142
Secondary outcomes (1)
Percentage of Participants With Clinical Response
Clinical response was based on the improvement of disease-specific signs and symptoms. Responders are defined as participants meeting all the following criteria: improvement of disease-specific signs and symptoms and no new signs, symptoms or complications attributable to the initial infection; No evidence of drainage, sinus tract formation or infection-related bone instability; No requirement for subsequent antibiotics with activity against Staphylococcus to treat the initial infection after the start of study treatment; Microbiological eradication of the baseline pathogen (if post-baseline sample[s] are available); Imaging test at 12 weeks post-EOT showing no worsening of baseline pathology or presence of signs indicating resolution or healing of the infection. Percentages are rounded off.
Measured: Part A: At Day 8, EOT (up to Day 22), 4-weeks post-EOT (up to Day 50), and 12-weeks post-EOT (up to Day 130); Part B: At Day 8, Day 28, Day 42, EOT (up to Day 43), 4-weeks post-EOT (up to Day 73), and 12-weeks post-EOT (up to Day 142)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start20 Feb 2019
- Primary completion23 Apr 2025
- Study completion23 Apr 2025
Why it stopped: This trial was concluded for strategic reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone or Joint InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Debiopharm International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723551
- Sponsor's protocol ID
- Debio 1450-BJI-205
- Status last verified
- Sep 2026
- First submitted
- 26 Oct 2018
- Last updated
- 9 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open-label Active-controlled Study to Assess the Safety, Tolerability, and Efficacy of Afabicin IV/Oral in the Treatment of Patients With Bone or Joint Infection Due to Staphylococcus
- ClinicalTrials.gov ID
- NCT03723551
- Acronym / sponsor ID
- Debio 1450-BJI-205
- Conditions
- Bone or Joint Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This trial was concluded for strategic reasons.
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Debiopharm International SAIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Posted 9 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, active-controlled, open-label study to assess the safety, tolerability and efficacy of Afabicin in the treatment of participants with bone or joint infection due to Staphylococcus aureus [both methicillin-susceptible S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA)] and/or coagulase-negative staphylococci (CoNS) and to compare it to standard of care (SoC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part A: Afabicin: Cohort 1 | Experimental | Drug: AfabicinParticipants received afabicin intravenously (IV) at a dose of 160 milligrams (mg), twice daily (BID), followed by a switch to oral afabicin at a dose of 240 mg, BID, for 2-3 weeks. |
| Part A: Afabicin: Cohort 2 | Experimental | Drug: AfabicinParticipants received afabicin IV at a dose of 160 mg, BID, followed by a switch to oral afabicin at a dose of 240 mg, BID, for 3-6 weeks. |
| Part A: SoC: Cohort 1 | Active comparator | Drug: Cefazolin, Drug: Vancomycin, Drug: Linezolid, Drug: ClindamycinParticipants with oxacillin-/methicillin-susceptible staphylococci were administered with either cefazolin or vancomycin or linezolid or clindamycin, IV or linezolid or clindamycin, orally; participants with oxacillin-/methicillin-resistant staphylococci were administered either vancomycin or clindamycin or linezolid, IV or linezolid or clindamycin, orally, as part of SoC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule. |
| Part A: SoC: Cohort 2 | Active comparator | Drug: Cefazolin, Drug: Vancomycin, Drug: Linezolid, Drug: ClindamycinParticipants with oxacillin-/methicillin-susceptible staphylococci were administered with either cefazolin or vancomycin or linezolid or clindamycin, IV or linezolid or clindamycin, orally; participants with oxacillin-/methicillin-resistant staphylococci were administered either vancomycin or clindamycin or linezolid, IV or linezolid or clindamycin, orally, as part of SoC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule. |
| Part B: Afabicin: Cohort 1 | Experimental | Drug: AfabicinParticipants received afabicin IV at a dose of 55 mg, BID, followed by a switch to oral afabicin at a dose of 80 mg, BID, for 2-3 weeks. |
| Part B: Afabicin: Cohort 2 | Experimental | Drug: AfabicinParticipants received afabicin IV at a dose of 55 mg, BID, followed by a switch to oral afabicin at a dose of 80 mg, BID, for 3-6 weeks. |
| Part B: SoC: Cohort 1 | Active comparator | Drug: Cefazolin, Drug: Vancomycin, Drug: Linezolid, Drug: ClindamycinParticipants with oxacillin-/methicillin-susceptible staphylococci were administered with either cefazolin or vancomycin or linezolid or clindamycin, IV or linezolid or clindamycin, orally; participants with oxacillin-/methicillin-resistant staphylococci were administered either vancomycin or clindamycin or linezolid, IV or linezolid or clindamycin, orally, as part of SoC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule. |
| Part B: SoC: Cohort 2 | Active comparator | Drug: Cefazolin, Drug: Vancomycin, Drug: Linezolid, Drug: ClindamycinParticipants with oxacillin-/methicillin-susceptible staphylococci were administered with either cefazolin or vancomycin or linezolid or clindamycin, IV or linezolid or clindamycin, orally; participants with oxacillin-/methicillin-resistant staphylococci were administered either vancomycin or clindamycin or linezolid, IV or linezolid or clindamycin, orally, as part of SoC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to provide written informed consent and to comply with study procedures.
- Diagnosis of bone or joint infection which fulfils the following conditions: a) Infection is due to S. aureus (MSSA or MRSA) and/or CoNS only; and, b) Participants had received no more than 7 days of empiric antibiotics prior to initiating treatment with study drug unless the pathogen isolated was resistant to the administered empiric antibiotics; and, c) Biofilm is not considered to be yet established and/or has been mechanically eradicated; and, d) Infection is not associated with an ischiatic or a sacral osteomyelitis; and e) Infection can involve periosteal or soft tissue.
Key exclusion criteria (11 listed)
- Presence of co-infection with non-staphylococcal bacteria at the affected joint or bone site, or in the blood.
- Participants at an increased risk of developing liver injury.
- Participants who have medical conditions that increase the risk of QT prolongation.
- Medical history within the previous 3 months of: myocardial infarction, unstable angina pectoris, coronary artery or cerebral revascularization procedure or stroke, ventricular tachycardia, multifocal ventricular ectopics requiring treatment, or any other clinically relevant symptomatic ventricular arrhythmias.
- Documented history of alcohol or drug abuse within the previous 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfabicinAdministered intravenously and orally. | Drug | Part A: Afabicin: Cohort 1, Part A: Afabicin: Cohort 2, Part B: Afabicin: Cohort 1, Part B: Afabicin: Cohort 2 |
| CefazolinAdministered intravenously. | Drug | Part A: SoC: Cohort 1, Part A: SoC: Cohort 2, Part B: SoC: Cohort 1, Part B: SoC: Cohort 2 |
| VancomycinAdministered intravenously. | Drug | Part A: SoC: Cohort 1, Part A: SoC: Cohort 2, Part B: SoC: Cohort 1, Part B: SoC: Cohort 2 |
| LinezolidAdministered intravenously and orally. | Drug | Part A: SoC: Cohort 1, Part A: SoC: Cohort 2, Part B: SoC: Cohort 1, Part B: SoC: Cohort 2 |
| ClindamycinAdministered intravenously and orally. | Drug | Part A: SoC: Cohort 1, Part A: SoC: Cohort 2, Part B: SoC: Cohort 1, Part B: SoC: Cohort 2 |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 142
Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. TEAE is any undesirable event either not present prior to medical treatment or worsening (in intensity or frequency) following treatment. SAE is defined as any untoward medical occurrence that at any dose: results in death; is life-threatening (i.e., puts the patient at immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect, or is otherwise medically significant.
Number of Participants With Grade Shift From Baseline in Hematology Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.03
Time frame: Up to Day 142
Laboratory abnormalities were graded according to NCI CTCAE v4.03. Grade 0 indicates a normal value; Grades 1-4 represent increasing severity of abnormalities outside the normal range. "High" and "Low" indicate values above and below the normal range, respectively. At baseline (last assessment prior to randomization), both "High, Grade 0" and "Low, Grade 0" indicate normal values and identify the direction of the subsequent post-baseline shift. Participants were evaluated separately for High and Low shifts. Participant could contribute to both analyses if shifts occurred in opposite directions at different assessments. These categories are not mutually exclusive; therefore, counts should not be summed across directions, as they may exceed the number of participants analyzed. Participant could not be classified as both High and Low at the same assessment. Only categories with at least one participant showing a shift were reported.
Number of Participants With Grade Shift From Baseline in Clinical Chemistry Parameters Based on NCI-CTCAE v4.03
Time frame: Up to Day 142
Laboratory abnormalities were graded according to NCI CTCAE v4.03. Grade 0 indicates a normal value; Grades 1-4 represent increasing severity of abnormalities outside the normal range. "High" and "Low" indicate values above and below the normal range, respectively. At baseline (last assessment prior to randomization), both "High, Grade 0" and "Low, Grade 0" indicate normal values and identify the direction of the subsequent post-baseline shift. Participants were evaluated separately for High and Low shifts. Participant could contribute to both analyses if shifts occurred in opposite directions at different assessments. These categories are not mutually exclusive; therefore, counts should not be summed across directions, as they may exceed the number of participants analyzed. Participant could not be classified as both High and Low at the same assessment. Only categories with at least one participant showing a shift were reported.
Number of Participants With Grade Shift From Baseline in Electrolyte Parameters Based on NCI-CTCAE v4.03
Time frame: Up to Day 142
Laboratory abnormalities were graded according to NCI CTCAE v4.03. Grade 0 indicates a normal value; Grades 1-4 represent increasing severity of abnormalities outside the normal range. "High" and "Low" indicate values above and below the normal range, respectively. At baseline (last assessment prior to randomization), both "High, Grade 0" and "Low, Grade 0" indicate normal values and identify the direction of the subsequent post-baseline shift. Participants were evaluated separately for High and Low shifts. Participant could contribute to both analyses if shifts occurred in opposite directions at different assessments. These categories are not mutually exclusive; therefore, counts should not be summed across directions, as they may exceed the number of participants analyzed. Participant could not be classified as both High and Low at the same assessment. Only categories with at least one participant showing a shift were reported.
Number of Participants With Grade Shift From Baseline in Coagulation Parameters Based on NCI-CTCAE v4.03
Time frame: Up to Day 142
Laboratory abnormalities were graded according to NCI CTCAE v4.03. Grade 0 indicates a normal value; Grades 1-4 represent increasing severity of abnormalities outside the normal range. "High" and "Low" indicate values above and below the normal range, respectively. At baseline (last assessment prior to randomization), both "High, Grade 0" and "Low, Grade 0" indicate normal values and identify the direction of the subsequent post-baseline shift. Participants were evaluated separately for High and Low shifts. Participant could contribute to both analyses if shifts occurred in opposite directions at different assessments. These categories are not mutually exclusive; therefore, counts should not be summed across directions, as they may exceed the number of participants analyzed. Participant could not be classified as both High and Low at the same assessment. Only categories with at least one participant showing a shift were reported.
Number of Participants With Post-baseline Clinically Significant Urinalysis Abnormalities
Time frame: Up to Day 142
Clinical significance of abnormalities in urinalysis was determined based on the investigator's discretion. Baseline is defined as the last assessment prior to the randomization.
1 secondary outcome
Percentage of Participants With Clinical Response
Time frame: Part A: At Day 8, EOT (up to Day 22), 4-weeks post-EOT (up to Day 50), and 12-weeks post-EOT (up to Day 130); Part B: At Day 8, Day 28, Day 42, EOT (up to Day 43), 4-weeks post-EOT (up to Day 73), and 12-weeks post-EOT (up to Day 142)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Afabicin, Cefazolin and Vancomycin in people with Bone or Joint Infection, run by Debiopharm International SA at 19 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Ukraine, Georgia, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Up to Day 142). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.