Clostridium DifficilePhase 2NCT02563106
A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI
A Phase 2 study testing SYN-004 in people with Clostridium Difficile and Clostridium Infections, run by Theriva Biologics, Inc. at 43 sites in 7 countries.
Trial summary
A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of Clostridium difficile Infection (CDI) in Hospitalized Patients receiving IV ceftriaxone with a Diagnosis of a Lower Respiratory Tract Infection (LRTI). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Clostridium Difficile, Clostridium Infections
- What is being tested?
- SYN-004
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 413 participants
- Where
- 43 sitesin 7 countries
- Study dates
- Oct 2015to Nov 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Expected minimum hospital stay of 5 days
- Expected ≥5 day course of intravenous (IV) ceftriaxone alone or in combination with a macrolide
- Clinical diagnosis of moderate to severe lower respiratory tract infection consisting of signs and symptoms of a lower respiratory tract infection and Pneumonia Severity Index (PSI/PORT) score for CAP of 90-130, inclusive. Evidence of a new or progressive infiltrate on chest x-ray is recommended.
Who cannot join
- Presence of a diarrheal illness within 72 hours prior to randomization
- Current treatment for CDAD or ongoing active CDI, as evidenced by clinical signs of diarrhea along with the presence of toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool
- Number of previous CDAD episodes >1 within 12 weeks of randomization and no C. difficile infection (CDI) within 4 weeks of randomization
- Use of antibiotics within 1 month of start of study drug except for the current illness.
Trial locations and contacts
43 sites in 7 countries.
43 sites in 7 countries
Poland11 sites
Synthetic Biologics Investigational Site
Bialystok
Synthetic Biologics Investigational Site
Bochnia
Synthetic Biologics Investigational Site
Bydgoszcz
Synthetic Biologics Investigational Site
Chodzież
Synthetic Biologics Investigational Site
Lodz
Synthetic Biologics Investigational Site
Oława
Synthetic Biologics Investigational Site
Pomorskie
Synthetic Biologics Investigational Site
Siedlce
Synthetic Biologics Investigational Site
Tarnów
SyntheticBiologics Investigational Site
Tychy
Synthetic Biologics Investigational Site
Warszawice
Bulgaria8 sites
Synthetic Biologics Investigational Site
Gabrovo
Synthetic Biologics Investigational Site
Kyustendil
Synthetic Biologics Investigational Site
Lovech
Synthetic Biologics Investigational Site
Multiple Locations
Synthetic Biologics Investigational Site
Rousse
Synthetic Biologics Investigational Site
Sevlievo
Synthetic Biologics Investigational Site
Sofia
Synthetic Biologics Investigational Site
Targovishte
Romania7 sites
Synthetic Biologics Investigational Site
Arad
Synthetic Biologics Investigational Site
Brasov
Synthetic Biologics Investigational SIte
Bucharest
Synthetic Biologics Investigational Site
Cluj-Napoca
Synthetic Biologics Investigational Site
Oradea
Synthetic Biologics Investigational Site
Otopeni
Synthetic Biologics Investigational Site
Timișoara
United States6 sites
Synthetic Biologics Investigational Site
Będzin, Louisiana, 71457
Synthetic Biologics Investigational Site
Debrecen, Louisiana, 71457
Synthetic Biologics Investigational Site
DeLand, Florida, 32720
Synthetic Biologics Investigational Site
Little Rock, Arkansas, 72205
Synthetic Biologics Investigational SIte
Natchitoches, Louisiana, 71457
Synthetic Biologics Investigational Site
Torrance, California, 90502
Serbia6 sites
Synthetic Biologics Investigational Site
Belgrade
Synthetic Biologics Investigational Site
Čačak
Synthetic Biologics Investigational Site
Gornji Matejevac
Synthetic Biologics Investigational Site
Kragujevac
Synthetic Biologics Investigational Site
Novi Sad
Synthetic Biologics Investigational Site
Užice
Hungary3 sites
Synthetic Biologics Investigational Site
Balassagyarmat
Synthetic Biologics Investigational Site
Budapest
Synthetic Biologics Investigational Site
Veszprém
Canada2 sites
Synthetic Biologics Investigational Site
Sherbrooke
Synthetic Biologics Investigational Site
Toronto
About this study
Official title: A Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of C.Diff in Patients With a Diagnosis of a Lower Respiratory Tract Infection
A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of Clostridium difficile Infection (CDI) in Hospitalized Patients receiving IV ceftriaxone with a Diagnosis of a Lower Respiratory Tract Infection (LRTI).
Read the detailed description
This is a Phase 2b, randomized, double-blind, placebo controlled, parallel-group, multi-center proof-of-concept study to assess the potential of SYN-004 in the prevention of CDI and the unwanted side effects of IV antibiotic treatment in at risk patients who are hospitalized for LRTI and receiving IV ceftriaxone alone or in combination with a macrolide. Subjects will be 50 years or older. The entire duration of the study may be up to 59 days. All patients will be evaluated for the occurrence of CDI and AAD by testing according to local diagnostic standards and monitoring for diarrhea (3 or more unformed stools per 24 hour period).
- Conditions
- Clostridium Difficile, Clostridium Infections
- Being tested
- SYN-004, Placebo
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYN-004Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| SYN-004 | Experimental | SYN-004 150 mg Receives: Drug: SYN-004 |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Clostridium Difficile Infection at 4- Weeks of Follow-up.
Percentage of subjects with CDI, based on the protocol definition of CDI (defined as 3 or more unformed stools per 24 hour period and a stool sample being positive for C. difficile toxin A and/or B [or their respective genes, tcdA and/or tcdB], based on the clinical site local laboratory results) from Day 1 to the 4-week Follow-up Visit in the SYN-004 treatment group compared to the placebo group, imputing early termination without CDI as not being treatment failures.
Measured: Day 1 to the 4 week Follow-up Visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2016
- Study completionNov 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 Clostridium DifficileStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theriva Biologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Kaleko, MD, Study director, Synthetic Biologics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563106
- Sponsor's protocol ID
- SB-2-004-005
- Status last verified
- Oct 2018
- First submitted
- 28 Sep 2015
- Last updated
- 27 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kokai-Kun JF, Roberts T, Coughlin O, Le C, Whalen H, Stevenson R, Wacher VJ, Sliman J. Use of ribaxamase (SYN-004), a beta-lactamase, to prevent Clostridium difficile infection in beta-lactam-treated patients: a double-blind, phase 2b, randomised placebo-controlled trial. Lancet Infect Dis. 2019 May;19(5):487-496. doi: 10.1016/S1473-3099(18)30731-X. Epub 2019 Mar 15.
PubMed 30885591
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of C.Diff in Patients With a Diagnosis of a Lower Respiratory Tract Infection
- ClinicalTrials.gov ID
- NCT02563106
- Acronym / sponsor ID
- SB-2-004-005
- Conditions
- Clostridium Difficile, Clostridium Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Theriva Biologics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 29 Sep 2015 (estimated)
- Results
- Posted 12 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of Clostridium difficile Infection (CDI) in Hospitalized Patients receiving IV ceftriaxone with a Diagnosis of a Lower Respiratory Tract Infection (LRTI).
Detailed description
This is a Phase 2b, randomized, double-blind, placebo controlled, parallel-group, multi-center proof-of-concept study to assess the potential of SYN-004 in the prevention of CDI and the unwanted side effects of IV antibiotic treatment in at risk patients who are hospitalized for LRTI and receiving IV ceftriaxone alone or in combination with a macrolide. Subjects will be 50 years or older. The entire duration of the study may be up to 59 days. All patients will be evaluated for the occurrence of CDI and AAD by testing according to local diagnostic standards and monitoring for diarrhea (3 or more unformed stools per 24 hour period).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYN-004 | Experimental | Drug: SYN-004SYN-004 150 mg |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Expected minimum hospital stay of 5 days
- Expected ≥5 day course of intravenous (IV) ceftriaxone alone or in combination with a macrolide
- Clinical diagnosis of moderate to severe lower respiratory tract infection consisting of signs and symptoms of a lower respiratory tract infection and Pneumonia Severity Index (PSI/PORT) score for CAP of 90-130, inclusive. Evidence of a new or progressive infiltrate on chest x-ray is recommended.
Key exclusion criteria (4 listed)
- Presence of a diarrheal illness within 72 hours prior to randomization
- Current treatment for CDAD or ongoing active CDI, as evidenced by clinical signs of diarrhea along with the presence of toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool
- Number of previous CDAD episodes >1 within 12 weeks of randomization and no C. difficile infection (CDI) within 4 weeks of randomization
- Use of antibiotics within 1 month of start of study drug except for the current illness.
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 |
|---|---|---|
| SYN-004 | Drug | SYN-004 |
| Placebo | Drug | Placebo |
Primary outcome
Percentage of Patients With Clostridium Difficile Infection at 4- Weeks of Follow-up.
Time frame: Day 1 to the 4 week Follow-up Visit.
Percentage of subjects with CDI, based on the protocol definition of CDI (defined as 3 or more unformed stools per 24 hour period and a stool sample being positive for C. difficile toxin A and/or B [or their respective genes, tcdA and/or tcdB], based on the clinical site local laboratory results) from Day 1 to the 4-week Follow-up Visit in the SYN-004 treatment group compared to the placebo group, imputing early termination without CDI as not being treatment failures.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30885591Kokai-Kun JF, Roberts T, Coughlin O, Le C, Whalen H, Stevenson R, Wacher VJ, Sliman J. Use of ribaxamase (SYN-004), a beta-lactamase, to prevent Clostridium difficile infection in beta-lactam-treated patients: a double-blind, phase 2b, randomised placebo-controlled trial. Lancet Infect Dis. 2019 May;19(5):487-496. doi: 10.1016/S1473-3099(18)30731-X. Epub 2019 Mar 15.
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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.
Michael Kaleko, MD study director
Synthetic Biologics
43 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SYN-004 in people with Clostridium Difficile and Clostridium Infections, run by Theriva Biologics, Inc. at 43 sites in 7 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 3 inclusion and 4 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 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Poland, Bulgaria, Romania, United States, Serbia and 2 more countries. 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 12 Mar 2018). 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?
Percentage of Patients With Clostridium Difficile Infection at 4- Weeks of Follow-up. (time frame: Day 1 to the 4 week Follow-up Visit.). 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 NCT02563106, 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 27 Nov 2018.