A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI
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| ClinicalTrials.gov Identifier: NCT02563106 |
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Recruitment Status :
Completed
First Posted : September 29, 2015
Results First Posted : March 12, 2018
Last Update Posted : November 27, 2018
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Sponsor:
Synthetic Biologics Inc.
Information provided by (Responsible Party):
Synthetic Biologics Inc.
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Brief 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Clostridium Difficile Clostridium Infections | Drug: SYN-004 Drug: Placebo | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 413 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Prevention |
| 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 |
| Study Start Date : | October 2015 |
| Actual Primary Completion Date : | November 2016 |
| Actual Study Completion Date : | November 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: SYN-004
SYN-004 150 mg
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Drug: SYN-004 |
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Placebo Comparator: Placebo
Matching placebo
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Drug: Placebo |
Primary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563106
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Sponsors and Collaborators
Synthetic Biologics Inc.
Investigators
| Study Director: | Michael Kaleko, MD | Synthetic Biologics |
| Responsible Party: | Synthetic Biologics Inc. |
| ClinicalTrials.gov Identifier: | NCT02563106 History of Changes |
| Other Study ID Numbers: |
SB-2-004-005 |
| First Posted: | September 29, 2015 Key Record Dates |
| Results First Posted: | March 12, 2018 |
| Last Update Posted: | November 27, 2018 |
| Last Verified: | October 2018 |
Additional relevant MeSH terms:
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Infection Respiratory Tract Infections Clostridium Infections |
Respiratory Tract Diseases Gram-Positive Bacterial Infections Bacterial Infections |