Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT01460056
Eligibility Criteria:
1. Endotoxin-associated peritonitis (e-SP) subgroup:
1.1. Inclusion Criteria:
* On continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) at time of index event.
* Used 1 of 3 Baxter PD solutions recalled lots (Nutrineal 10G12G44, Nutrineal 10I13G42, or Dianeal 10I20G44) between 1 August 2010 and 31 December 2010.
* Has a documented diagnosis of e-SP (index event) between 1 August 2010 and 31 December 2010, defined as meeting 1 of the 2 criteria listed below:
* Cloudy PD effluent with an increased peritoneal leukocyte count \>100 mm3 and a negative bacterial culture; or
* Cloudy PD effluent which resolves without the use of antibiotics and with the discontinuation of the Baxter PD solutions recalled lot within 24 hours.
* Aged 18 years or older at time of index event.
1.2. Exclusion Criteria:
* Participation in an interventional clinical study (i.e., therapy or dietary interventions) during the applicable study period (from index event to 12-15 months post index event).
* Had a diagnosis of fungal peritonitis at the index event.
* Received antibiotics for the treatment of other infectious ailments within 1 week prior to the e-SP index event.
* Received antibiotics for the treatment of peritonitis (index event) prior to the collection of cloudy PD effluent for cell count and cultures.
* Had a diagnosis of bacterial peritonitis (BP) within 3 months prior to the e-SP index event.
* Pregnancy during the applicable study period (from index event to 12-15 months post index event).
2. Bacterial peritonitis (BP) subgroup
2.1. Inclusion criteria
* On CAPD or APD at time of index event.
* Used Baxter's PD solutions lots manufactured by Baxter (Dianeal, Extraneal, Nutrineal in Viaflex containers) between 1 December 2008 and 30 November 2010.
* Had a documented diagnosis of BP (index event), between 1 December 2008 and 31 December 2010, defined as meeting the 2 criteria listed below:
* Cloudy peritoneal dialysis (PD) effluent with an increased peritoneal leukocyte count \>100 mm3;
* Positive bacterial culture with a causative organism(s).
* Aged 18 year or older at time of index event.
2.2. Exclusion criteria
* Participation in an interventional clinical study (i.e., therapy or dietary interventions) during the applicable study period (from index event to 12-15 months post index event).
* Had a diagnosis of e-SP between 1 August 2010 and 31 December 2010.
* Had a diagnosis of fungal peritonitis at the index event.
* Pregnancy during the applicable study period (from index event to 12-15 months post index event).
3. No peritonitis (NoP) subgroup
3.1. Inclusion criteria
* On CAPD or APD at time of index event.
* Used 1 of 3 Baxter PD solution recalled lots (Nutrineal 10G12G44, Nutrineal 10I13G42, or Dianeal 10I20G44) between 1 August 2010 and 31 December 2010.
* Aged 18 year or older at time of index event.
3.2. Exclusion criteria
* Had a documented diagnosis of any type of peritonitis between 1 August 2010 and 31 December 2010.
* Participation in an interventional clinical study (i.e., therapy or dietary interventions) during the applicable study period (from index event to 12-15 months post index event).
* Pregnancy during the applicable study period (from index event to 12-15 months post index event).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01460056
Study Brief:
Protocol Section:
NCT01460056