CLINICAL TRIAL

Treatment for Cronobacter Infections

Recruiting · 18+ · All Sexes · Charlotte, NC

This study is evaluating whether a new antibiotic called Imipenem/Cilastatin/Relebactam (IMI/REL) is effective in treating Klebsiella Producing Carbapenemase Enterobacteriaceae

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About the trial for Cronobacter Infections

Eligible Conditions
Communicable Diseases · Infections · KPC · Carbapenem-Resistant Enterobacteriaceae Infection · Gram-Negative Bacterial Infections · Antibiotic Resistant Infection · Enterobacteriaceae Infections · Bacterial Infections

Treatment Groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The patient has the ability and willingness to give informed consent, and in some cases a legal authorized representative may be used when the patient is unable to provide informed consent. show original
Adult (>18 years of age) patients with a KPC-producing CRE infection at any site except for isolated urinary source. Patients may be initially enrolled once identified with a CRE infection defined as resistance to any carbapenem. Any carbapenem resistance will provide an initial mechanism of identifying study eligible patients in accordance with our institutions definition of CRE for infection prevention purposes. As this study is specific for KPC-producing CRE inclusion in the study analysis will require confirmation of a KPC gene by molecular analysis of the isolate and subjects enrolled may be subsequently removed from study and excluded from analysis if molecular testing reveals their CRE isolate to be a non-KPC mechanism of resistance. Polymicrobial infections at same or different sites can also be included as long as additional gram-negative active agents aside from IMI/REL are not needed for treatment.
The patient has a bacterial infection with a group of bacteria called Enterobacteriaceae, with the exception of a group of bacteria called Morganellaceae. show original
Previously, if someone had an Enterobacteriaceae infection containing KPC, they would not be able to enroll in a study to test the effectiveness of IMI/REL 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

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 90 days
Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 90 days.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 2 primary outcomes and 6 secondary outcomes in patients with Cronobacter Infections. Measurement will happen over the course of 30 days.

Mortality
30 DAYS
Survival at 30 days
30 DAYS
Clinical success by site of infection
30 DAYS
Clinical success in patients grouped by site of infection: bacteremia, respiratory, intra-abdominal infection, soft tissue, catheter associated and urinary tract. Subjects may be included in multiple groups if applicable for analysis.
30 DAYS
Clinical success
30 DAYS
Clinical success defined as survival at 30 days, resolution of signs and symptoms of infection, sterilization of blood cultures within 7 days of treatment initiation in patients with bacteremia, and absence of recurrent infections.
30 DAYS
90 day Mortality
90 DAYS
Survival at 90 days
90 DAYS
Adverse effects
90 DAYS
Incidence of nephrotoxicity, leukopenia, rash, hepatotoxicity, and seizure in treatment group
90 DAYS
Recurrence of infection
90 DAYS
Recurrence of CRE-containing infection within 90 days
90 DAYS
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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.

What is cronobacter infections?

Cronobacter spp are Gram positive, saprophytic pathogens that usually cause neonatal intestinal infection or bacteremia in newborns. They are part of the normal microbiota of fecal material but they are not normally found in food.\n

Anonymous Patient Answer

What are the signs of cronobacter infections?

CRP can be elevated but a negative Lactate dehydrogenase may be the first sign of a CRP that is due to a Gram negative infecting bacterium. The finding of a positive skin test may also be an early manifestation. Early referral to a paediatric emergency department is recommended for those with any of these signs when it is indicated that the bacterium is likely to be the cause.

Anonymous Patient Answer

What causes cronobacter infections?

It has been hypothesised that cronobacteriosis develops as the direct consequence of intestinal colonization by gram-negative bacilli that causes bacterial-mediated tissue damage in the gastrointestinal tract of a susceptible host. This damage leads to a compensatory increase in intestinal lactobacillary counts that, by some of the unknown means, stimulates the intestinal B cell IgA system to produce IgA against the intestinal bacilli, causing a more rapid establishment of the pathogen in the gut mucosal lamina propria. The consequent intestinal tissue damage causes impaired cell-mediated immunity and thus permits the persistence of the pathogen in the gastrointestinal tract.

Anonymous Patient Answer

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

This article presents the first survey of CBA detected cases in the United States. At least 20,000 cases occurred each year, with an estimated overall mortality rate of 9%. These are cases that would not have been diagnosed under the current "case definition." The incidence, however, is far higher than the previously reported numbers from Europe and Canada. These data, although somewhat speculative, are important for public health professionals who must estimate the number of CBA infections that occur each year in the United States. The prevalence of CBA infections is in the range previously reported from the United States and Canada.

Anonymous Patient Answer

What are common treatments for cronobacter infections?

The most common treatments are used in addition to antibiotics for either hospital-acquired or community-acquired cronobacter infections. However, there is still an overlap of many drugs that can be used. While some patients can be treated with simple antibiotics alone, in others, the use of medications in addition to antibiotics or in cases of resistance is more effective. Although the data available in the literature on treatment has its limitations, due to a relatively small sample size, this review is only a guide to treatment of cronobacter infections.

Anonymous Patient Answer

Can cronobacter infections be cured?

Currently no curative treatment has been approved to cure cranobacter infections. Patients are treated with either antibiotics, probiotics, or immunotherapy to manage their symptoms. However, in patients with cranobacter infections that were diagnosed in adolescence, the infection may have progressed to adulthood and may be more difficult to treat. The treatments are mostly palliative, and patients typically have a poor prognosis. Until a curative treatment for cranobacter infections is approved and proven to work, patients must rely on their physicians to manage their pain and symptoms. You can find the most recent medical articles that discuss cranobacter infections by using [Power](http://withpower.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

Although treatment has been shown to be more effective than a placebo, this study shows that this treatment is not universally more effective than placebo treatment in all people with an infection by a strain of C. difficile. Findings from a recent study are relevant because an infection by C. difficile may be more serious than other infections, and treatment with a viable therapy may not be as effective in people with a chronic infection when the treatment will be stopped.

Anonymous Patient Answer

Is treatment typically used in combination with any other treatments?

Treatment of a bacterial infection and a viral infection by a combination of treatments may be associated with a lower rate of treatment failure than treatment with a single treatment.

Anonymous Patient Answer

What does treatment usually treat?

Only the most common infections and the top three conditions were identified; even though there is often limited coverage, there were many conditions in the top 10, including 5 with potential to be treated by antibiotics (bacterial infections or a respiratory infection requiring antibiotics and/or a respiratory infection causing pneumonia). These data suggest an opportunity to improve coverage of some conditions. Future priorities should focus on the top 10 conditions to treat, some of which can be treated as outpatients, including respiratory tract infections, skin conditions, and urinary tract infections.

Anonymous Patient Answer

What are the latest developments in treatment for therapeutic use?

There are several new and exciting therapies in development that are intended specifically to treat infectious diseases. But, while promising, these treatments may not be fully developed yet. It is estimated that [a new therapy to treat a disease is only produced every 20 years or so, at most]. The process of filing a new drug with the U.S. Food and Drug Authority (FDA) often takes a minimum of 14 years and, at that point, it is no longer in the public interest to take risks on new medicines or treatments for infectious diseases. So, it may be a long time until a fully developed new therapeutic option is available.

Anonymous Patient Answer

How serious can cronobacter infections be?

This is the first study that examines the outcome if the infection is unrecognized or not treated, which is a highly important issue for doctors and nurses in the intensive-care unit, since most of patients are already critically ill when they experience a cronobacter infection.

Anonymous Patient Answer

How does treatment work?

Data from a recent study indicate that ciliary-dependent innate defences could control bacterial killing. The absence of CRY1/2 can explain the lack of protection against lethal infection by Cronobacter spp. We suggest that this result is consistent with a model for regulation of phagocytosis in which signalling mechanisms oppose killing, or at least restrain it.

Anonymous Patient Answer
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