End Stage Renal Disease, Peritoneal Dialysis-associated Peritonitis, Peritonitis
Conditions
Brief summary
This study aims to determine if the CloudCath device can detect infections related to peritoneal dialysis (peritonitis) as fast or faster than the current standard methods used by patients and doctors to detect such infections.
Detailed description
This study will evaluate the safety and effectiveness of the CloudCath System to detect the onset of peritonitis as compared to standard of care. Study Participants will connect the CloudCath System to their home peritoneal dialysis unit and the CloudCath System will analyze the effluent dialysis solution for changes associated with peritonitis. The system will alert the participant and healthcare provider if it detects a possible infection so they can be formally diagnosed by their healthcare provider. Following enrollment, Study Participants will use the CloudCath System for 12 continuous months. Study results from the ACT study will be compared to the results of the CATCH Study (Protocol number CC-P-001; NCT04515498). In CATCH, the Study Participants used a CloudCath System; however, the notification capabilities (per the CloudCath System algorithm) were deactivated.
Interventions
DEVICECloudCath System
The CloudCath System enables drainage and measures turbidity, reported as a numeric score, in peritoneal dialysate effluent.
Sponsors
CloudCath
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All study participants receive a CloudCath Device and use it at home adjunctively to their regular peritoneal dialysis system.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * currently using peritoneal dialysis * provides informed consent * willing to comply with the requirements of the study * has cellular data coverage at home Key
Exclusion criteria
* active or history of cancer requiring chemotherapy within prior 6 months * signs or symptoms of an active infection within 14 days prior to enrollment * peritonitis diagnosis within 30 days prior to enrollment * participating in another investigational device or drug study that may potentially affect study results * other medical, social or psychological problems that, in the opinion of the investigator, exclude the study participant from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to peritonitis diagnosis | 12-months | The time between detection by the CloudCath System and laboratory confirmation of peritonitis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agreement in peritonitis detection between the CloudCath System and clinical criteria. | 12-months | clinical criteria include: white blood cells (WBC) (\>100 cells per microliter or \>0.1 x10\^9/L), polymorphonuclear cells (PMN) (\>50%), microbiology culture results, gram staining, and peritonitis symptoms |
| Agreement in detection of clinically actionable events between the CloudCath System and laboratory reports and/or diagnosis | 12-months | Clinically actionable events defined as an event which requires treatment (i.e., prescribing medications, cleaning an exit site, etc) or intervention (i.e., PD catheter manipulation, removal). Events of interest for this protocol include, but are not limited to, peritonitis, exit site or tunnel infection, and peritoneal dialysis (PD) catheter dysfunction (including PD catheter-related bleeding and PD catheter-related drainage issues). |
| Agreement in detection of clinically relevant events based on CloudCath System, as compared to clinical laboratory results or diagnosis of a clinically relevant event. | 12-months | Clinically relevant events are defined as clinically actionable events, events treated preventatively or medically relevant events. |
| Sensitivity and Specificity of the CloudCath System to detect peritonitis as compared to diagnostic laboratory testing | 12-months | Analysis of sensitivity and specificity of CloudCath System detection of peritonitis, as compared to diagnostic laboratory testing |
Countries
United States
Contacts
Primary ContactBrian Fisher
Backup ContactConcetta Carbonaro
Outcome results
None listed