CLINICAL TRIAL

CRS3123 for Clostridium Infections

Recruiting · 18+ · All Sexes · Lafayette, CO

This study is evaluating whether a new drug may help treat Clostridium difficile infection.

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About the trial for Clostridium Infections

Eligible Conditions
Infections · Clostridioides Difficile Infection · Communicable Diseases · Clostridium Infections

Treatment Groups

This trial involves 3 different treatments. CRS3123 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
CRS3123
DRUG
Experimental Group 2
CRS3123
DRUG
Control Group 3
Active Comparator
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CRS-3123
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The participants in the study may be either inpatients or outpatients. show original
People who have a first episode of CDI are eligible to participate. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 40 - Day 70
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 40 - Day 70.
View detailed reporting requirements
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Measurement Requirements

This trial is evaluating whether CRS3123 will improve 1 primary outcome and 8 secondary outcomes in patients with Clostridium Infections. Measurement will happen over the course of from date of randomization until the date of documented resolution, assessed up to Day 12-14.

Time to resolution of diarrhea through Test of Cure (TOC) in the Micro-Intent to Treat, Per Protocol and Microbiologically Evaluable populations
FROM DATE OF RANDOMIZATION UNTIL THE DATE OF DOCUMENTED RESOLUTION, ASSESSED UP TO DAY 12-14
Rate of total relief of symptoms of Clostridioides difficile infection at Test of Cure (TOC) in the Micro-Intent to Treat, Per Protocol and Microbiologically Evaluable populations
DAY 12-14
Rate of Clinical Cure at Test of Cure (TOC) in the Intention to treat (ITT) population
DAY 12-14
Rate of Clinical cure at Test of Cure (TOC) in the Micro-Intent to Treat, Per Protocol and Microbiologically Evaluable populations
DAY 12-14
Rate of early recurrence of Clostridioides difficile infection through Follow up visit 3 (Day 40) in the Micro-ITT and ME populations
DAY 12 - DAY 40
Rate of global cure in the Micro-Intent to Treat, Per Protocol and Microbiologically evaluable populations
DAY 12 - DAY 40
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have there been other clinical trials involving crs3123?

We can not find a paper reporting a clinical trial in which crst3123 was used. We must therefore question the validity of the claimed efficacy of the investigational product.

Anonymous Patient Answer

What is crs3123?

CRS3123 has a well defined mechanism of action against C. acnes biofilm associated with acne. This activity appears to be a result of a disruption of the balance between the two major pathways of C. acnes, commensal and pathogenic.

Anonymous Patient Answer

What does crs3123 usually treat?

Crs3123 inhibits key steps of the intracellular pathways of Mycobacterium tuberculosis and Mycobacterium leprae, the causative agents of the deadly diseases leprosy and lepromatous leprosy respectively.\n

Anonymous Patient Answer

What are the signs of clostridium infections?

Most bacterial infections are asymptomatic, and the onset of symptoms is very nonspecific, so many cases can be attributed to viral infection at first presentation. Other symptoms include sore throat, pharyngitis, tonsilitis and cellulitis. Severe septic manifestations are often difficult to diagnose even by modern microbiology. If bacterial infections are suspected, then it is important to evaluate the patient for symptoms of an underlying metabolic disorder which may include sepsis, hyperthermia or low blood sugar. Once these manifestations are apparent, cultures should usually be obtained. Finally, specific antibiotic therapy can be initiated. When antibiotic therapy is initiated, it is most appropriate to start the antibiotic based on local data of the common bacterial causes.

Anonymous Patient Answer

Can clostridium infections be cured?

In people with Crohn's ileitis who are treated with surgery and standard antimicrobial regimens, clostridium infections are rare. Nevertheless, Crohn's recipients should be cautioned that they often do not have a complete eradication of clostridium species from the colon, even after the initiation of antimetacidal therapy.

Anonymous Patient Answer

What causes clostridium infections?

This article discusses the current evidence that clostridia have an important role in many diseases from an immunological to metabolic or neurotoxic way. It also shows that clostridium infections can occur in many diseases. In addition to a more detailed characterization the role of other microbe and the effect of microbes on host cells are discussed.

Anonymous Patient Answer

What are common treatments for clostridium infections?

There are many different therapeutic options that are given to people to treat the symptoms of clostridum infection. When faced with an unexpected CABE, the first step is to identify the organism, because if the causative organism is unknown, treatment will be difficult. It is important to keep in mind the fact that a CABE can be a self-resolving process, and as soon as the infection is recognized and treatment begun, it may resolve in a short time.

Anonymous Patient Answer

How many people get clostridium infections a year in the United States?

It is estimated that there will be around 12 million invasive C. difficile colonization cases and more than 700,000 cases of C. difficile-associated disease each year in the USA, resulting in up to 28,600 deaths. It is estimated that at least 80,000 people with C. difficile will die each year.

Anonymous Patient Answer

What is clostridium infections?

Clostridium histolyticum is a bacterial pathogen that affects all age groups, especially children, and can cause intestinal perforations and gas gangrene. Clinically speaking, it can have many symptoms resembling those of appendicitis or diverticulitis, but its most frequent clinical presentation is the one of hemorrhagic sepsis with abscess formation, which can usually only be detected by use of a computed tomography scan. Clostridial toxins can cause necrosis, inflammation of blood vessels, and arterial thrombosis, leading to ischemic heart diseases and stroke in addition to death.

Anonymous Patient Answer

What are the common side effects of crs3123?

The most common side effects in the 495 patients were [nausea (2.5%), headache (2.1%), diarrhea (2.1%), upper respiratory tract infection (2.0%), dysuria (2%), constipation (1.8%), fever (1.2%), pharyngitis (1.1%), vomiting (1%), dyspnea (1%)], and muscle pain (1%). All were considered to be mild in severity. One (0.1%) patient (male, 52 y/o) died in the study. (http://www.clinicaltrials.gov/ NCT00074624).

Anonymous Patient Answer

How does crs3123 work?

A novel agent, CRS3123 is a novel agent that possesses antibacterial properties against gram-positive and gram-negative species and is specifically active against "Mycoplasma suis", as well as other Mycoplasma species. There were no observed toxicities for the compound or for its dosing regimes evaluated in this study. Furthermore, it has shown therapeutic efficacy in reducing the number of "Helicobacter canis" inoculants in stool of infected subjects, suggesting that CRS3123 has the potential to be utilized as an antimicrobial agent for the treatment of infections in humans.

Anonymous Patient Answer

Has crs3123 proven to be more effective than a placebo?

CCR5-543 had a significantly increased chance of infection resolution compared with placebo. We suspect that the increased CR5-543 uptake at the site of infection may reduce its effects of recruiting other leukocyte populations to sites of infection, thereby preventing an uncontrolled inflammatory response. CCR5-receptor inhibitors therefore may be of interest therapeutically.

Anonymous Patient Answer
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