Bacterial InfectionsPhase 2NCT02426918

Study of Debio 1450 for Bacterial Skin Infections

A Phase 2 study testing Debio 1450 IV, Debio 1450 Oral and Linezolid in people with Bacterial Infections, run by Debiopharm International SA at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to evaluate the efficacy of 2 different doses of intravenous and oral Debio 1450 compared with intravenous vancomycin and oral linezolid in the treatment of patients with staphylococcal ABSSSI. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Bacterial Infections
What is being tested?: Debio 1450 IV, Debio 1450 Oral and Linezolid
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 330 participants
Where: 22 sitesUnited States
Study dates: May 2015to Sep 2016
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has clinically documented infection of the skin or skin structure suspected or documented to be caused by a staphylococcal pathogen
Meets other protocol-specified criteria for qualification and contraception
Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Who cannot join

Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
the safety or well-being of the participant or study staff;
the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
the analysis of results

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

United States22 sites

Dream Team Clinical Research, LLC
Anaheim, California, 91776
Physician Alliance Research Center
Anaheim, California, 92804
Southbay Pharma Research
Buena Park, California, 90620
Mercury Street Medical Group PLLC
Butte, Montana, 59701
eStudySite - Chula Vista
Chula Vista, California, 91911
Columbus Regional Research
Columbus, Georgia, 31904
Shands Burn Center at the University of Florida
Gainesville, Florida, 32610
East Montgomery County Clinic
Houston, Texas, 77070
eStudySite - La Mesa
La Mesa, California, 91942
eStudySite - Las Vegas
Las Vegas, Nevada, 89109
Long Beach Clinical Trials LLC
Long Beach, California, 90806
Alliance Research
Long Beach, California, 90813
Central Valley Research, LLC
Modesto, California, 95350
eStudySite - Oceanside
Oceanside, California, 92056
Central Florida Internists
Orlando, Florida, 32811
Beaumont Infectious Disease Services
Royal Oak, Michigan, 48073
South Jersey Infectious Disease
Somers Point, New Jersey, 08244
Tidwell Medical Center
Splendora, Texas, 77372
Olive View - UCLA Medical Center
Sylmar, California, 91342
Holy Name Medical Center
Teaneck, New Jersey, 07666
ID Clinical Research, Ltd.
Toledo, Ohio, 43608
Triple O Research Institute
West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-Blind, Multicenter Study of Safety, Tolerability, and Efficacy of Debio 1450 vs Vancomycin (IV)/Linezolid (Oral) in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Due to Staphylococcus Sensitive or Resistant to Methicillin

Conditions: Bacterial Infections
Being tested: Debio 1450 IV, Debio 1450 Oral, Linezolid, Debio 1450 Oral Placebo, Linezolid Placebo
Medical subject headings: Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Debio 1450 IVDrug
Intravenous (IV) form of Debio 1450 will be supplied in vials containing 50 mg of active pharmaceutical ingredient (API). Intravenous infusions of Debio 1450 (160 mg and 80 mg) will be administered over a 2-hour period BID every 12 hours within a 2-hour window (12 ± 2 hours).
Debio 1450 OralDrug
Oral forms of Debio 1450 will be provided as white, opaque, hard gelatin capsules containing 50 mg drug substance (equivalent to 40 mg of Debio 1450).
LinezolidDrug
Linezolid for oral administration will be provided as 600-mg film-coated compressed tablets.
Debio 1450 Oral PlaceboDrug
Debio 1450 placebo will be supplied as white, opaque, hard gelatin capsules.
Linezolid PlaceboDrug
Linezolid placebo will be supplied as film-coated compressed tablets.
Vancomycin IVDrug
Vancomycin will be administered BID every 12 ± 2 hours at doses of 1 g or 15 mg/kg as specified in local protocols, with the infusion rate adjusted to 2 hours.

Study groups in NCT02426918
Study group	Role	What they receive
Debio 1450 320/480 mg	Experimental	After 2 doses of Debio 1450 IV (intravenous) therapy, the Debio 1450 320/480 mg daily dose group receives 240 mg Debio 1450 Oral + Linezolid Placebo twice daily (BID). Receives: Drug: Debio 1450 IV; Drug: Debio 1450 Oral; Drug: Linezolid Placebo
Debio 1450 160/240 mg	Experimental	After 2 doses of Debio 1450 IV therapy, the Debio 1450 160/240 mg daily dose group receives 120 mg Debio 1450 Oral + Debio 1450 Oral Placebo + Linezolid Placebo BID. Receives: Drug: Debio 1450 IV; Drug: Debio 1450 Oral; Drug: Debio 1450 Oral Placebo; Drug: Linezolid Placebo
Placebo	Placebo comparator	After 2 doses of Vancomycin IV, the Placebo comparator group receives Debio 1450 Oral Placebo + Linezolid 600 mg BID. Receives: Drug: Linezolid; Drug: Debio 1450 Oral Placebo; Drug: Vancomycin IV

What is being measured

The primary outcome is the main question the study is designed to answer.

Early Clinical Response Rate (ECRR): Percentage of Responders to Treatment at 48 to 72 Hours From Randomization as Assessed by the Investigator
ECRR was defined as the percentage of responders to treatment at 48 to 72 hours from randomization. Responders were the participants who showed greater than or equal to (≥) 20% reduction in area of the primary lesion involving erythema, edema, or induration of the primary ABSSSI lesion (as assessed by the ruler method) at 48 to 72 hours compared to baseline.
Measured: At 48 to 72 hours from randomization (Day 4)

Secondary outcomes (4)

Clinical Success Rate: Percentage of Participants Assessed by the Investigator as Responders at 48 to 72 Hours From Randomization, at End of Treatment (EOT) and Short-term Follow-up (STFU)
The Investigator Assessment of Clinical Outcome (IACO) of treatment was assessed for each participant as success or failure at 48 to 72 hours after randomization at EOT and STFU visits. Clinical success was resolution or near resolution of most disease-specific signs and symptoms and no new signs, symptoms, or complications attributable to ABSSSI such that no further antibiotic therapy is required for treatment of original site of infection. Clinical failure was requirement for additional antibiotic therapy for treatment of the original site of infection or incision and drainage of ABSSSI site that was not both anticipated and completed within a 48- to 72-hour window following randomization, or unplanned major surgical intervention required due to failure of study medication or development of osteomyelitis after baseline. Participants who met both success criteria and none of failure criteria were considered as a clinical success for IACO.
Measured: 48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19)
Clinical Success Rate: Percentage of Participants Assessed by the Sponsor as Responders After 7 to 10 Days of Treatment at EOT and STFU
The Sponsor's Assessment of Clinical Outcome was obtained at EOT and STFU visits based on IACO and additional criteria. Sponsor assessed participants as clinical failure if they required non-study or rescue antibiotics due to lack of efficacy after at least 48 hours from randomization or experienced drug-related serious adverse events (SAEs) or discontinuation of study medication for drug-related AEs or required antibiotic therapy for longer than 10 days or had the need for unplanned surgical intervention >48 hours after randomization. As per IACO, clinical success was resolution or near resolution of most disease-specific signs and symptoms and no new signs, symptoms or complications. Clinical failure was requirement for additional antibiotic therapy or incision and drainage of ABSSSI site or unplanned major surgical intervention or development of osteomyelitis.
Measured: EOT (Day 12) and STFU (Day 19)
Percentage of Participants With a Composite Assessment of Clinical Outcome (CACO) of Success
CACO of treatment was determined as a combined outcome of early response to treatment (at 48 to 72 hours from randomization) and IACO at the STFU visit. Participants had a CACO of success if they met both of the following criteria: An early response to treatment (at 48 to 72 hours from randomization) (ECR = responder) and a clinical outcome of success at the STFU visit (7 to 14 days after EOT) based on IACO (IACO = success).
Measured: 48 to 72 hours after randomization (Day 4) and STFU (Day 19)
Percentage of Participants Who Showed Microbiological Evidence of Cure 48 to 72 Hours From Randomization, EOT, and STFU
The microbiological outcome was assessed by the sponsor at 48 to 72 hours from randomization, EOT and STFU. It was based on blood and skin lesion identification results from baseline samples and skin lesion identification results from baseline samples and skin lesion identification results from follow-up samples as well as on, molecular typing results, and the IACO. Microbiological eradication rate was defined as proportion of participants with 'Documented Eradication' (absence of baseline pathogen(s) in follow-up cultures of the original site of infection.) or 'Presumed Eradication' (no material available for culture and an IACO of 'Success') in relation to the total number of participants in the respective treatment group.
Measured: 48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Sep 2016

First posted27 Apr 2015 (estimated)
Study startMay 2015
Primary completionAug 2016
Study completionSep 2016

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 (1)Papers the sponsor has linked to this study.
Other trials for Bacterial 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 330 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02426918
Sponsor's protocol ID: Debio 1450-ABSSSI-201
Other IDs: 218187
Status last verified: Oct 2019
First submitted: 22 Apr 2015
Last updated: 13 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Wittke F, Vincent C, Chen J, Heller B, Kabler H, Overcash JS, Leylavergne F, Dieppois G. Afabicin, a First-in-Class Antistaphylococcal Antibiotic, in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Clinical Noninferiority to Vancomycin/Linezolid. Antimicrob Agents Chemother. 2020 Sep 21;64(10):e00250-20. doi: 10.1128/AAC.00250-20. Print 2020 Sep 21.
PubMed 32747361

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-Blind, Multicenter Study of Safety, Tolerability, and Efficacy of Debio 1450 vs Vancomycin (IV)/Linezolid (Oral) in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Due to Staphylococcus Sensitive or Resistant to Methicillin
ClinicalTrials.gov ID: NCT02426918
Acronym / sponsor ID: Debio 1450-ABSSSI-201
Conditions: Bacterial Infections
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 330 participants (actual)
Lead sponsor: Debiopharm International SAIndustry (pharma, biotech, devices)
Study start: May 2015
Primary completion: Aug 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 27 Apr 2015 (estimated)
Results: Posted 13 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Debio 1450 320/480 mg	Experimental	Drug: Debio 1450 IV, Drug: Debio 1450 Oral, Drug: Linezolid PlaceboAfter 2 doses of Debio 1450 IV (intravenous) therapy, the Debio 1450 320/480 mg daily dose group receives 240 mg Debio 1450 Oral + Linezolid Placebo twice daily (BID).
Debio 1450 160/240 mg	Experimental	Drug: Debio 1450 IV, Drug: Debio 1450 Oral, Drug: Debio 1450 Oral Placebo, Drug: Linezolid PlaceboAfter 2 doses of Debio 1450 IV therapy, the Debio 1450 160/240 mg daily dose group receives 120 mg Debio 1450 Oral + Debio 1450 Oral Placebo + Linezolid Placebo BID.
Placebo	Placebo comparator	Drug: Linezolid, Drug: Debio 1450 Oral Placebo, Drug: Vancomycin IVAfter 2 doses of Vancomycin IV, the Placebo comparator group receives Debio 1450 Oral Placebo + Linezolid 600 mg BID.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Has clinically documented infection of the skin or skin structure suspected or documented to be caused by a staphylococcal pathogen
Meets other protocol-specified criteria for qualification and contraception
Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Key exclusion criteria (5 listed)

Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

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
Debio 1450 IVIntravenous (IV) form of Debio 1450 will be supplied in vials containing 50 mg of active pharmaceutical ingredient (API). Intravenous infusions of Debio 1450 (160 mg and 80 mg) will be administered over a 2-hour period BID every 12 hours within a 2-hour window (12 ± 2 hours).	Drug	Debio 1450 160/240 mg, Debio 1450 320/480 mg
Debio 1450 OralOral forms of Debio 1450 will be provided as white, opaque, hard gelatin capsules containing 50 mg drug substance (equivalent to 40 mg of Debio 1450).	Drug	Debio 1450 160/240 mg, Debio 1450 320/480 mg
LinezolidLinezolid for oral administration will be provided as 600-mg film-coated compressed tablets.	Drug	Placebo
Debio 1450 Oral PlaceboDebio 1450 placebo will be supplied as white, opaque, hard gelatin capsules.	Drug	Debio 1450 160/240 mg, Placebo
Linezolid PlaceboLinezolid placebo will be supplied as film-coated compressed tablets.	Drug	Debio 1450 160/240 mg, Debio 1450 320/480 mg
Vancomycin IVVancomycin will be administered BID every 12 ± 2 hours at doses of 1 g or 15 mg/kg as specified in local protocols, with the infusion rate adjusted to 2 hours.	Drug	Placebo

Primary outcome

Early Clinical Response Rate (ECRR): Percentage of Responders to Treatment at 48 to 72 Hours From Randomization as Assessed by the Investigator
Time frame: At 48 to 72 hours from randomization (Day 4)
ECRR was defined as the percentage of responders to treatment at 48 to 72 hours from randomization. Responders were the participants who showed greater than or equal to (≥) 20% reduction in area of the primary lesion involving erythema, edema, or induration of the primary ABSSSI lesion (as assessed by the ruler method) at 48 to 72 hours compared to baseline.

4 secondary outcomes

Clinical Success Rate: Percentage of Participants Assessed by the Investigator as Responders at 48 to 72 Hours From Randomization, at End of Treatment (EOT) and Short-term Follow-up (STFU)
Time frame: 48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19)
Clinical Success Rate: Percentage of Participants Assessed by the Sponsor as Responders After 7 to 10 Days of Treatment at EOT and STFU
Time frame: EOT (Day 12) and STFU (Day 19)
Percentage of Participants With a Composite Assessment of Clinical Outcome (CACO) of Success
Time frame: 48 to 72 hours after randomization (Day 4) and STFU (Day 19)
Percentage of Participants Who Showed Microbiological Evidence of Cure 48 to 72 Hours From Randomization, EOT, and STFU
Time frame: 48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19)

Results and safety

Results posted to the registry on 13 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Debio 1450 80 mg (Milligrams)/120 mg BID	110	93
Debio 1450 160 mg/240 mg BID	109	90
Vancomycin/Linezolid BID	111	97

Primary outcome: Early Clinical Response Rate (ECRR): Percentage of Responders to Treatment at 48 to 72 Hours From Randomization as Assessed by the Investigator

Time frame: At 48 to 72 hours from randomization (Day 4). Number. Unit: percentage of participants

Measure	Debio 1450 80 mg/120 mg BID n = 92	Debio 1450 160 mg/240 mg BID n = 91	Vancomycin/Linezolid BID n = 101
Value	94.6	90.1	91.1

Debio 1450 80 mg/120 mg BID vs Vancomycin/Linezolid BID: Risk Difference (RD): -4.2 (95% CI -11.42 to 3.00)
Debio 1450 160 mg/240 mg BID vs Vancomycin/Linezolid BID: Risk Difference (RD): 0.0 (95% CI -8.32 to 8.38)

Population analysed: Microbiological Intent-to-Treat (mITT) population included all randomized participants who were culture positive for any staphylococcal species considered pathogenic and received at least one dose of study medication.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 21 days after EOT (Day 33). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Debio 1450 80 mg/120 mg BID	2 of 110 (1.8%)	18 of 110 (16.4%)	Not reported
Debio 1450 160 mg/240 mg BID	1 of 107 (0.9%)	29 of 107 (27.1%)	Not reported
Vancomycin/Linezolid BID	1 of 107 (0.9%)	20 of 107 (18.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32747361Wittke F, Vincent C, Chen J, Heller B, Kabler H, Overcash JS, Leylavergne F, Dieppois G. Afabicin, a First-in-Class Antistaphylococcal Antibiotic, in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Clinical Noninferiority to Vancomycin/Linezolid. Antimicrob Agents Chemother. 2020 Sep 21;64(10):e00250-20. doi: 10.1128/AAC.00250-20. Print 2020 Sep 21.

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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.

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Debio 1450 IV, Debio 1450 Oral and Linezolid in people with Bacterial Infections, run by Debiopharm International SA at 22 sites in United States.

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 4 inclusion and 5 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 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. 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. Some participants in this study may receive a placebo. 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 13 Nov 2019). 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 Rate (ECRR): Percentage of Responders to Treatment at 48 to 72 Hours From Randomization as Assessed by the Investigator (time frame: At 48 to 72 hours from randomization (Day 4)). 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 NCT02426918, which also lists 1 linked publication.

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 13 Nov 2019.