Acute Bacterial Skin and Skin Structure InfectionsPhase 3NCT03137173
Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections
A Phase 3 study testing ceftobiprole medocaril and vancomycin+aztreonam in people with Acute Bacterial Skin and Skin Structure Infections, run by Basilea Pharmaceutica at 34 sites in 4 countries.
Trial summary
This was a randomized, double-blind, active-controlled, parallel-group, multicenter study in adult hospitalized patients to establish the safety and efficacy of ceftobiprole medocaril compared with vancomycin plus aztreonam in the treatment of acute bacterial skin and skin structure infections (ABSSSIs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Bacterial Skin and Skin Structure Infections
- What is being tested?
- ceftobiprole medocaril and vancomycin+aztreonam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 679 participants
- Where
- 34 sitesin 4 countries
- Study dates
- 19 Feb 2018to 22 Apr 2019
- Phase
- Phase 3
- 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
- Male or female, aged ≥18 years.
- Diagnosis of ABSSSI, meeting at least one of the definitions in (a) to (c) below. Local symptoms must have started within the 7 days prior to the Screening visit:
- Cellulitis/erysipelas, defined as a diffuse skin infection characterized by all of the following within 24 hours:
- i. Rapidly spreading areas of erythema, edema, and/or induration with a minimum total lesion surface area of 75cm^2
- ii. No collection of pus apparent upon visual examination
- iii. At least two of the following local signs of infection:
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- erythema
- induration
- localized warmth
- pain or tenderness on palpation
- swelling/edema
- Major cutaneous abscess, defined as infection characterized by a collection of pus within the dermis or deeper that is apparent upon visual examination before or after therapeutic intervention and is accompanied by all of the following within 24 hours:
- i. Erythema, edema and/or induration with a minimum total lesion surface area of 75 cm^2.
- ii. At least two of the following local signs of infection:
- fluctuance
- incision and drainage required
- purulent or seropurulent drainage
- localized warmth
- pain or tenderness on palpation
- Wound infection, defined as infection of any apparent break in the skin characterized by at least one of the following:
- i. Superficial incision/surgical site infection meeting all of the following criteria:
- involves only the skin or subcutaneous tissue around the incision (does not involve fascia).
- occurs within 30 days of procedure.
- purulent drainage (spontaneous or therapeutic) with surrounding erythema, edema and/ or induration with a minimum total lesion surface area of 75cm^2.
- ii. Post-traumatic wound (including penetrating trauma, e.g., needle, nail, knife, insect and spider bites) meeting the following criterion within 24 hours:
- Purulent drainage (spontaneous or therapeutic) with surrounding erythema, edema and/or induration with a minimum total lesion surface area of 75cm^2.
- At least one of the following regional or systemic signs of infection at the Screening visit:
- Lymph node tenderness and volume increase, or palpable lymph node proximal to the primary ABSSSI.
- Fever > 38 °C/100.4 °F measured orally, > 38.5 °C / 101.3 °F measured tympanically, > 37.5 °C / 99.5 °F measured by the axillary method, or > 39 °C / 102.2 °F measured rectally.
- White blood cell (WBC) count > 10.0 × 10^9/L or < 4.0 × 10^9/L.
- > 10% immature neutrophils (band forms).
- Requirement for IV antibacterial treatment.
- Willing and able to adhere to study procedures (including prohibitions and restrictions) as specified in this protocol.
- Willing and able to remain hospitalized (in a hospital or equivalent medical confinement or clinical research unit) until completion of the early-clinical-response assessment for the primary endpoint.
- Informed consent signed by the patient, or their legally acceptable representative if appropriate, indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate.
Who cannot join
- Patients meeting any one of the following:
- Use of any systemic antibacterial treatment within 14 days, or topical antibacterial administration on the primary lesion within 96 hours, before first infusion of study drug.
- Exception: Receipt of a single dose of a short acting (half-life ≤ 12 hours) antibacterial therapy (e.g., for surgical prophylaxis) within > 3 days before randomization (i.e., patients cannot have received any antibacterial treatment within 72 hours of randomization).
- Contraindication to the administration of either of the study treatments, including known clinically-relevant hypersensitivity to related antibacterial treatments (e.g., beta-lactam and glycopeptide antibiotics), or to metronidazole if required as adjunctive therapy.
- Participation in any other clinical study within the 30 days prior to randomization, or any prior participation in this study.
- The primary ABSSSI is an uncomplicated skin and skin structure infection, such as furuncles, minor abscesses (area of suppuration not surrounded by cellulitis/erysipelas), impetiginous lesions, superficial or limited cellulitis/erysipelas, or minor wound infections (e.g., stitch abscesses).
Show all 30Show fewer
- The primary ABSSSI is due to, or associated with, any of the following:
- Diabetic foot infection, gangrene, or perianal abscess.
- Concomitant infection at another site (e.g., septic arthritis, endocarditis, osteomyelitis), not including a secondary ABSSSI lesion.
- Infected burns.
- Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease (arterial or venous).
- Any evolving necrotizing process (e.g., necrotizing fasciitis).
- Infections at vascular catheter sites, or involving thrombophlebitis.
- The primary ABSSSI is associated with, or in close proximity to, a prosthetic device.
- Patients who are placed in a hyperbaric chamber as adjunctive therapy for the ABSSSI.
- Patients expected to require more than two surgical interventions in the operating room for the ABSSSI.
- Severe sepsis or septic shock.
- Significant or life-threatening condition (e.g., endocarditis, meningitis) that would confound, or interfere with, the assessment of the ABSSSI.
- Another severe, acute or chronic medical condition, psychiatric condition, or laboratory abnormality that may increase the risks associated with study participation or administration of the investigational product, or may interfere with the interpretation of study results, and which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- Receiving treatment for active tuberculosis.
- Absolute neutrophil count < 0.5 × 10^9/L.
- Recent history of opportunistic infections (i.e., within 30 days) if the underlying cause of these infections is still active (e.g., leukemia, transplant, acquired immunodeficiency syndrome [AIDS]).
- Patients receiving systemic steroids (> 40 mg per day prednisolone, or equivalent), or receiving immunosuppressant drugs.
- Requirement for peritoneal dialysis, plasmapheresis, hemodialysis, venovenous dialysis, or other forms of renal filtration, or expected to require such treatment before the TOC visit.
- Alanine transaminase (ALT) or aspartate transaminase (AST) levels ≥ 8× the upper limit of normal, OR severe hepatic disease with Child-Pugh class C.
- Women who are pregnant or nursing.
- Women who are of childbearing potential and unwilling to use an acceptable method of birth control during the study: female sterilization (bilateral tubal occlusion or oophorectomy, or hysterectomy) or male partner vasectomy; intrauterine device (IUD); combined (estrogen and progesterone containing) hormonal contraception (oral, vaginal ring, or transdermal patch) with an ethinylestradiol dose of at least 30 µg, plus use of male condoms (preferably with spermicides), female condoms, a female diaphragm or a cervical cap; or total sexual abstinence.
- Women are not considered to be of childbearing potential if they are either ≥ 1 year post-menopausal (where menopause is defined as at least 12 months of amenorrhea), or have a serum follicle stimulating hormone (FSH) measurement consistent with post-menopausal status according to local laboratory thresholds. An FSH measurement at Screening is to be obtained for post-menopausal females aged < 50 years, or for those aged ≥ 50 years who have been post-menopausal for < 2 years.
- Inability to start study-drug therapy within 24 hours of Screening.
- Patients with illicit drug use within 12 months of screening, including heroin, other opioids (unless prescribed for medical reasons unrelated to heroin substitution), cocaine / crack cocaine, and amphetamine or methamphetamine. Exception: Cannabis use.
Trial locations and contacts
34 sites in 4 countries.
34 sites in 4 countries
United States16 sites
Physician Alliance Research Center
Anaheim, California, 92804
Saint Joseph's Clinical Research
Anaheim, California, 92804
Mercury Street Medical Group
Butte, Montana, 59701
eStudySite - Chula Vista - PPDS
Chula Vista, California, 91911
Gonzalez MD and Aswad MD Health Services
Coral Gables, Florida, 33134
Central Valley Research LLC
Fresno, California, 93721
Marvel Clinical Research
Huntington Beach, California, 92647
eStudySite - La Mesa - PPDS
La Mesa, California, 91942
Omnibus Clinical Research
La Palma, California, 90623
eStudySite - Las Vegas - PPDS
Las Vegas, Nevada, 89109
Excel Clinical Research
Las Vegas, Nevada, 89109
Alliance Research LLC
Long Beach, California, 90813
Long Beach Clinical Trials
Long Beach, California, 90813
L&C Professional Medical Research Institute
Miami, Florida, 33144
Central Valley Research, LLC
Modesto, California, 95350
South Jersey Infectious Disease
Somers Point, New Jersey, 08244
Ukraine10 sites
Dnipropetrovsk I.I. Mechnуkov Regional Clinical Hospital, Surgery Department #2
Dnipro, 49005
Ivano-Frankivsk City Clinical Hospital Surgery 1
Ivano-Frankivsk, 76008
Ivano-Frankivsk City Clinical Hospital General Surgery
Ivano-Frankivsk, 76018
Kyiv City Clinical Hospital
Kyiv, 03110
Public City Clinical Hospital of Emergency Medical Care
Lviv, 79000
Lviv Regional Clinical Hospital
Lviv, 79059
Central City Clinical Hospital
Uzhhorod, 88000
Vinnytsia M.I. Pyrohov Regional Clinical Hospital
Vinnytsia, 21018
Zaporizhia City Clinical Hospital of Urgent and Emergency Medical Care
Zaporizhia, 69000
Central District Hospital
Zhytomyr, 12430
Bulgaria4 sites
University Multiprofile Hospital for Active Treatment
Pleven, 5800
University Multiprofile Hospital for Active Treatment
Plovdiv, 4004
University Multiprofile Hospital for Active Treatment
Rousse, 7002
"University Multiprofile Hospital for Active Treatment and Emergency Medicine ""N. I. Pirogov"", Clinic of Purulent-Septic Surgery-"N.I. Pirogov""
Sofia, 1606
Hungary4 sites
Kaposi Mor Teaching Hospital
Kaposvár, 7400
CRU Hungary Ltd.
Miskolc, 3529
University of SzegednAlbert Szent-Gyorgyi Clinical Center
Szeged, 6720
Csolnoky Ferenc Hospital
Veszprém, 8200
About this study
Official title: A Randomized, Double-blind, Multicenter Study to Establish the Safety and Efficacy of Ceftobiprole Medocaril Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections
This was a randomized, double-blind, active-controlled, parallel-group, multicenter study in adult hospitalized patients to establish the safety and efficacy of ceftobiprole medocaril compared with vancomycin plus aztreonam in the treatment of acute bacterial skin and skin structure infections (ABSSSIs).
Read the detailed description
This was a randomized, double-blind, active-controlled, parallel-group, multicenter study in adult hospitalized patients with ABSSSIs. Randomization was stratified by study site and type of ABSSSI (with major cutaneous abscess comprising ≤ 30% of the Intent-to-Treat [ITT] population).
Primary endpoint for FDA: Early clinical response based on the percent reduction in lesion size at 48-72 hours compared to baseline in patients who did not receive rescue therapy and were alive, in the ITT population.
Primary endpoint for EMA: Investigator-assessed clinical success at the test-of-cure (TOC) visit 15-22 days after randomization, in the co-primary ITT and Clinically Evaluable (CE) populations.
- Being tested
- ceftobiprole medocaril, vancomycin+aztreonam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftobiprole medocarilDrug
Also called ceftobiprole
ceftobiprole 500 mg was to be administered every 8 hours as a 2-hour IV infusion (with dose adjustment for renal impairment). The treatment duration was for a minimum of 5 days and a maximum of 10 days. Treatment could be extended up to 14 days if in the investigator's opinion this was required, and the extension was approved by the sponsor's medical monitor.
vancomycin+aztreonamDrug
Vancomycin 1000 mg (or 15 mg/kg) was to be administered every 12 hours (with dose adjustment for renal impairment) as 2-hour IV infusion. Vancomycin dose adjustment for morbidly obese and hypermetabolic patients was to be done according to local standard of care. When locally available, vancomycin trough testing (VTT) might have been used by the unblinded pharmacist or delegate to adjust the vancomycin dose. The treatment duration was for a minimum of 5 days and a maximum of 10 days. Treatment could be extended up to 14 days if in the investigator's opinion this was required, and the extension was approved by the sponsor's medical monitor.
Aztreonam 1000 mg was to be administered as a 0.5-hour IV infusion every 12 hours. If CLCR was < 30 mL/min (i.e., severe renal impairment), the aztreonam dosage regimen was to be adjusted. The requirement to continue aztreonam therapy beyond Day 3 was to be reassessed at the 72-hour study visit.
| Study group | Role | What they receive |
|---|---|---|
| ceftobiprole medocaril | Experimental | Patients treated with ceftobiprole medocaril 500 mg q8h (with dose adjustment for renal impairment). Receives: Drug: ceftobiprole medocaril |
| vancomycin+aztreonam | Active comparator | Patients treated with vancomycin 1000 mg (or 15 mg/kg) q12h plus aztreonam 1000 mg q12h (both with dose adjustment for renal impairment). Receives: Drug: vancomycin+aztreonam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Clinical Response
Comparison of early clinical response, including ≥ 20% reduction from baseline in the primary lesion area (based on ruler measurements), survival for ≥ 72 hours and no rescue therapy in the ITT population
Measured: 48-72 hours after start of study drug treatment
Secondary outcomes (2)
Investigator-assessed Clinical Success in the ITT Population
Comparison of investigator-assessed clinical success (based on resolution of baseline signs and symptoms of the primary infection) in the ITT population
Measured: 15-22 days after randomization
Investigator-assessed Clinical Success in the Clinically Evaluable (CE) Population
Comparison of investigator-assessed clinical success (based on resolution of baseline signs and symptoms of the primary infection) in the clinically evaluable (CE) population
Measured: 15-22 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start19 Feb 2018
- Primary completion22 Apr 2019
- Study completion22 Apr 2019
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Bacterial Skin and Skin Structure InfectionsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 679 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Marc Engelhardt, MD, Study director, Basilea Pharmaceutica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137173
- Sponsor's protocol ID
- BPR-CS-008
- Other IDs
- HHSO100201600002C
- Status last verified
- Sep 2026
- First submitted
- 27 Apr 2017
- Last updated
- 18 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Welte T, Scheeren TW, Overcash JS, Saulay M, Engelhardt M, Hamed K. Efficacy and safety of ceftobiprole in patients aged 65 years or older: a post hoc analysis of three Phase III studies. Future Microbiol. 2021 May;16:543-555. doi: 10.2217/fmb-2021-0042. Epub 2021 May 7.
PubMed 33960817Overcash JS, Kim C, Keech R, Gumenchuk I, Ninov B, Gonzalez-Rojas Y, Waters M, Simeonov S, Engelhardt M, Saulay M, Ionescu D, Smart JI, Jones ME, Hamed KA. Ceftobiprole Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Results of a Phase 3, Randomized, Double-blind Trial (TARGET). Clin Infect Dis. 2021 Oct 5;73(7):e1507-e1517. doi: 10.1093/cid/ciaa974.
PubMed 32897367
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter Study to Establish the Safety and Efficacy of Ceftobiprole Medocaril Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections
- ClinicalTrials.gov ID
- NCT03137173
- Acronym / sponsor ID
- BPR-CS-008
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 679 participants (actual)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Posted 18 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a randomized, double-blind, active-controlled, parallel-group, multicenter study in adult hospitalized patients to establish the safety and efficacy of ceftobiprole medocaril compared with vancomycin plus aztreonam in the treatment of acute bacterial skin and skin structure infections (ABSSSIs).
Detailed description
This was a randomized, double-blind, active-controlled, parallel-group, multicenter study in adult hospitalized patients with ABSSSIs. Randomization was stratified by study site and type of ABSSSI (with major cutaneous abscess comprising ≤ 30% of the Intent-to-Treat [ITT] population).
Primary endpoint for FDA: Early clinical response based on the percent reduction in lesion size at 48-72 hours compared to baseline in patients who did not receive rescue therapy and were alive, in the ITT population.
Primary endpoint for EMA: Investigator-assessed clinical success at the test-of-cure (TOC) visit 15-22 days after randomization, in the co-primary ITT and Clinically Evaluable (CE) populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ceftobiprole medocaril | Experimental | Drug: ceftobiprole medocarilPatients treated with ceftobiprole medocaril 500 mg q8h (with dose adjustment for renal impairment). |
| vancomycin+aztreonam | Active comparator | Drug: vancomycin+aztreonamPatients treated with vancomycin 1000 mg (or 15 mg/kg) q12h plus aztreonam 1000 mg q12h (both with dose adjustment for renal impairment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- Male or female, aged ≥18 years.
- Diagnosis of ABSSSI, meeting at least one of the definitions in (a) to (c) below. Local symptoms must have started within the 7 days prior to the Screening visit:
- At least one of the following regional or systemic signs of infection at the Screening visit:
- Requirement for IV antibacterial treatment.
- Willing and able to adhere to study procedures (including prohibitions and restrictions) as specified in this protocol.
Key exclusion criteria (30 listed)
- Use of any systemic antibacterial treatment within 14 days, or topical antibacterial administration on the primary lesion within 96 hours, before first infusion of study drug.
- Exception: Receipt of a single dose of a short acting (half-life ≤ 12 hours) antibacterial therapy (e.g., for surgical prophylaxis) within > 3 days before randomization (i.e., patients cannot have received any antibacterial treatment within 72 hours of randomization).
- Contraindication to the administration of either of the study treatments, including known clinically-relevant hypersensitivity to related antibacterial treatments (e.g., beta-lactam and glycopeptide antibiotics), or to metronidazole if required as adjunctive therapy.
- Participation in any other clinical study within the 30 days prior to randomization, or any prior participation in this study.
- The primary ABSSSI is an uncomplicated skin and skin structure infection, such as furuncles, minor abscesses (area of suppuration not surrounded by cellulitis/erysipelas), impetiginous lesions, superficial or limited cellulitis/erysipelas, or minor wound infections (e.g., stitch abscesses).
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 |
|---|---|---|
| ceftobiprole medocarilAlso: ceftobiproleceftobiprole 500 mg was to be administered every 8 hours as a 2-hour IV infusion (with dose adjustment for renal impairment). The treatment duration was for a minimum of 5 days and a maximum of 10 days. Treatment could be extended up to 14 days if in the investigator's opinion this was required, and the extension was approved by the sponsor's medical monitor. | Drug | ceftobiprole medocaril |
| vancomycin+aztreonamVancomycin 1000 mg (or 15 mg/kg) was to be administered every 12 hours (with dose adjustment for renal impairment) as 2-hour IV infusion. Vancomycin dose adjustment for morbidly obese and hypermetabolic patients was to be done according to local standard of care. When locally available, vancomycin trough testing (VTT) might have been used by the unblinded pharmacist or delegate to adjust the vancomycin dose. The treatment duration was for a minimum of 5 days and a maximum of 10 days. Treatment could be extended up to 14 days if in the investigator's opinion this was required, and the extension was approved by the sponsor's medical monitor. Aztreonam 1000 mg was to be administered as a 0.5-hour IV infusion every 12 hours. If CLCR was < 30 mL/min (i.e., severe renal impairment), the aztreonam dosage regimen was to be adjusted. The requirement to continue aztreonam therapy beyond Day 3 was to be reassessed at the 72-hour study visit. | Drug | vancomycin+aztreonam |
Primary outcome
Early Clinical Response
Time frame: 48-72 hours after start of study drug treatment
Comparison of early clinical response, including ≥ 20% reduction from baseline in the primary lesion area (based on ruler measurements), survival for ≥ 72 hours and no rescue therapy in the ITT population
2 secondary outcomes
Investigator-assessed Clinical Success in the ITT Population
Time frame: 15-22 days after randomization
Investigator-assessed Clinical Success in the Clinically Evaluable (CE) Population
Time frame: 15-22 days after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33960817Welte T, Scheeren TW, Overcash JS, Saulay M, Engelhardt M, Hamed K. Efficacy and safety of ceftobiprole in patients aged 65 years or older: a post hoc analysis of three Phase III studies. Future Microbiol. 2021 May;16:543-555. doi: 10.2217/fmb-2021-0042. Epub 2021 May 7.
- Derived from this study: PubMed 32897367Overcash JS, Kim C, Keech R, Gumenchuk I, Ninov B, Gonzalez-Rojas Y, Waters M, Simeonov S, Engelhardt M, Saulay M, Ionescu D, Smart JI, Jones ME, Hamed KA. Ceftobiprole Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Results of a Phase 3, Randomized, Double-blind Trial (TARGET). Clin Infect Dis. 2021 Oct 5;73(7):e1507-e1517. doi: 10.1093/cid/ciaa974.
- 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.
Marc Engelhardt, MD study director
Basilea Pharmaceutica
34 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ceftobiprole medocaril and vancomycin+aztreonam in people with Acute Bacterial Skin and Skin Structure Infections, run by Basilea Pharmaceutica at 34 sites in 4 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 35 inclusion and 30 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: finished, as of the sponsor's last update on 18 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 34 sites in United States, Ukraine, Bulgaria, Hungary. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 18 May 2020). 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?
Early Clinical Response (time frame: 48-72 hours after start of study drug treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03137173, which also lists 2 linked publications.
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 18 Sep 2026.