What is the mechanism of action of this treatment?

The most common treatments for Peritoneal Dialysis Peritonitis involve the use of broad-spectrum antibiotics, such as cephalosporins or vancomycin for Gram-positive bacteria and aminoglycosides or ceftazidime for Gram-negative bacteria. These antibiotics work by inhibiting bacterial cell wall synthesis or protein synthesis, leading to bacterial cell death. Early and effective treatment is crucial for peritoneal dialysis patients to prevent complications, preserve peritoneal membrane function, and reduce morbidity. The CloudCath device aims to detect infections early, potentially allowing for prompt antibiotic administration, which is vital for improving patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for peritoneal dialysis peritonitis include antibiotics such as vancomycin, cephalosporins, and aminoglycosides. Known side effects of these treatments can include nephrotoxicity (kidney damage), ototoxicity (hearing loss), gastrointestinal disturbances, and allergic reactions. Monitoring for these side effects is crucial to ensure patient safety and effective management of the infection.

What prior FDA approvals exist?

Peritoneal dialysis peritonitis is typically treated with intraperitoneal antibiotics, such as vancomycin or ceftazidime, which are administered directly into the peritoneal cavity. The FDA has approved various antibiotics for this purpose, focusing on their efficacy in eliminating the infection and preventing complications. Monitoring devices like the CloudCath aim to detect early signs of infection, potentially allowing for prompt treatment and better outcomes. While specific FDA approvals for monitoring devices like CloudCath are not detailed, the general approach involves using approved antibiotics and enhancing infection detection and management through innovative monitoring technologies.

What other types of research exist?

Promising novel alternatives to the CloudCath device for monitoring and detecting signs of infection in peritoneal dialysis patients include: 1) Remote Patient Monitoring (RPM) systems that utilize non-invasive digital technologies to track patient health metrics and alert healthcare providers to potential infections. 2) Telemedicine platforms that enable real-time communication and data sharing between patients and healthcare providers, facilitating early detection and intervention. 3) Advanced urine biomarkers and rapid diagnostic tests that can detect early signs of infection with high sensitivity and specificity. These alternatives leverage technology to provide timely and accurate monitoring, potentially improving patient outcomes.

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Diagnostic Device

CloudCath Monitoring for Peritoneal Dialysis Infections (ACT Trial)

N/A

Recruiting

Research Sponsored by CloudCath

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently using peritoneal dialysis

Be older than 18 years old

Must not have

Signs or symptoms of an active infection within 14 days prior to enrollment

Active or history of cancer requiring chemotherapy within prior 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the CloudCath device, which connects to home dialysis machines to check for infections. It targets patients on peritoneal dialysis who are at risk of peritonitis. The device monitors the dialysis fluid and alerts both the patient and their doctor if it detects possible signs of infection.

Who is the study for?

This trial is for individuals currently using in-home peritoneal dialysis, who can give informed consent and will follow the study's requirements. They must have cellular data at home. People with recent cancer treatments, peritonitis, current infections, or involvement in other studies that could affect results are excluded.

What is being tested?

The CloudCath System is being tested to see if it can detect infections from peritoneal dialysis quicker or as quickly as existing methods. The goal is to improve early infection detection which is crucial for patients undergoing this treatment.

What are the potential side effects?

Since the CloudCath System is a diagnostic device rather than a medication, traditional side effects like those seen with drugs are not expected. However, there may be risks associated with incorrect readings leading to delayed infection management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently on peritoneal dialysis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not had signs of an infection in the last 14 days.

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I have had cancer treatment within the last 6 months.

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I was diagnosed with peritonitis in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to peritonitis diagnosis

Secondary study objectives

Agreement in detection of clinically actionable events between the CloudCath System and laboratory reports and/or diagnosis

Agreement in detection of clinically relevant events based on CloudCath System, as compared to clinical laboratory results or diagnosis of a clinically relevant event.

Agreement in peritonitis detection between the CloudCath System and clinical criteria.

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CloudCath detectionExperimental Treatment1 Intervention

Active monitoring of dialysate effluent by the CloudCath System.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Peritoneal Dialysis Peritonitis involve the use of broad-spectrum antibiotics, such as cephalosporins or vancomycin for Gram-positive bacteria and aminoglycosides or ceftazidime for Gram-negative bacteria. These antibiotics work by inhibiting bacterial cell wall synthesis or protein synthesis, leading to bacterial cell death. Early and effective treatment is crucial for peritoneal dialysis patients to prevent complications, preserve peritoneal membrane function, and reduce morbidity. The CloudCath device aims to detect infections early, potentially allowing for prompt antibiotic administration, which is vital for improving patient outcomes.