A Phase 2 interventional study of SYN-004 and Placebo in Clostridium Difficile and Clostridium Infections, sponsored by Theriva Biologics, Inc.. Completed at 43 sites in 7 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-11-27.
Sponsored by Theriva Biologics, Inc. · Phase 2, Interventional, and Prevention
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).
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).
251 studies on the registry are indexed under Clostridium Infections; 51 are open to participants now.
This study's enrollment of 413 is above the median of 64 across 185 interventional studies indexed under Clostridium Infections.
Browse Clostridium Infections studies →Theriva Biologics, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
SYN-004 150 mg
Drug: SYN-004
Matching placebo
Drug: Placebo
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.
Time frame: Day 1 to the 4 week Follow-up Visit.
| Milestone | SYN-004 | Placebo |
|---|---|---|
| Started | 206 | 207 |
| Completed | 172 | 178 |
| Not completed | 34 | 29 |
| Withdrew: Withdrawal by subject | 7 | 8 |
| Withdrew: Adverse event | 17 | 15 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Use of non-permitted concurrent therapy | 1 | 2 |
| Withdrew: Lost to follow-up | 3 | 2 |
| Withdrew: Physician decision | 3 | 1 |
| Withdrew: Other reason - not specified | 2 | 1 |
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.
| Participants | SYN-004 | Placebo |
|---|---|---|
| Percentage of Patients With Clostridium Difficile Infection at 4- Weeks of Follow-up. | 2 | 7 |
Collected over 6 weeks.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SYN-004 | 11/206 (5.3%) | 33/206 (16%) | 59/206 (28.6%) |
| Placebo | 5/206 (2.4%) | 21/206 (10.2%) | 59/206 (28.6%) |
| Event | SYN-004 | Placebo |
|---|---|---|
| PneumoniaInfections and infestations | 4/206 | 5/206 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 4/206 | 2/206 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 3/206 | 4/206 |
| Pulmonary oedemaRespiratory, thoracic and mediastinal disorders | 0/206 | 3/206 |
| Atrial fibrillationCardiac disorders | 2/206 | 0/206 |
| Cardiac failureCardiac disorders | 1/206 | 2/206 |
| CardiomyopathyCardiac disorders | 0/206 | 2/206 |
| BronchopneumoniaInfections and infestations | 2/206 | 0/206 |
| HaematuriaRenal and urinary disorders | 2/206 | 0/206 |
| Chronic respiratory failureRespiratory, thoracic and mediastinal disorders | 2/206 | 0/206 |
| Event | SYN-004 | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 9/206 | 11/206 |
| HypertensionVascular disorders | 7/206 | 10/206 |
| InsomniaNervous system disorders | 4/206 | 9/206 |
| ConstipationGastrointestinal disorders | 7/206 | 6/206 |
| HeadacheNervous system disorders | 5/206 | 6/206 |
| NauseaGastrointestinal disorders | 5/206 | 3/206 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 4/206 | 4/206 |
| Atrial FibrillationCardiac disorders | 3/206 | 2/206 |
| Oral CandidiasisInfections and infestations | 3/206 | 3/206 |
| CholelithiasisHepatobiliary disorders | 3/206 | 2/206 |
One subject in the placebo group was randomized but never dosed. The subject withdrew consent prior to dosing, therefore they are not included in the analysis population.
| Age, Continuous(years) | SYN-004 | Placebo | Total |
|---|---|---|---|
| Mean | 68.8 ± 9.37 | 69.7 ± 9.37 | 69.2 ± 9.37 |
| Sex: Female, Male(Participants) | SYN-004 | Placebo | Total |
|---|---|---|---|
| Female | 73 | 80 | 153 |
| Male | 133 | 126 | 259 |
| Race (NIH/OMB)(Participants) | SYN-004 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 206 | 205 | 411 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | SYN-004 | Placebo | Total |
|---|---|---|---|
| Europe | 203 | 201 | 404 |
| North America | 3 | 4 | 7 |
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SYN-004
Theriva Biologics, Inc.