Chicken antibodies (IgY) for the eradication of ESBL-Klebsiella pneumoniae and E coli in carriers

A randomized, placebo-controlled, double blind, parallel group phase II study of anti-ESBL IgY for the eradication of ESBL Klebsiella pneumoniae and Escherichia coli in faeces in carriers

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011446-26-SE

Enrollment

140

Registered

2011-05-02

Start date

2011-07-04

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feacal carriage of ESBL producing Klebsiella pneumoniae and/or E. coli.

Interventions

Product Name: Anti-ESBL IgY Product Code: Not applicable Pharmaceutical Form: Oral solution Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age = 18 years. • Positive faecal test for ESBL-gene and positive culture for ESBL Klebsiella pneumoniae and/or Escherichia coli in at least one of two samples taken during screening at the same occasion (duplicate sample). • Written Informed Consent. • Male and female • No antimicrobial therapy within 14 days prior to start of treatment Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: • Swallowing dysfunction • Egg allergy • Anticipated bad compliance • Participation in any other clinical trial

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the efficacy of Anti-ESBL IgY compared to placebo in order to eradicate intestinal carriage with ESBL Klebsiella pneumoniae and E coli.;Secondary Objective: Efficacy: absence/recurrence of ESBL, i.e. negative faecal sample during and after treatment Safety/tolerability: in terms of adverse events ;Primary end point(s): The primary endpoint is eradication of faecal carriage with ESBL-producing K. pneumoniae and/or E. coli at Day 21 (end of treatment) and is measured as the proportion of ESBL negative subjects at Day 21. Eradication is defined as both samples negative in a duplicate sample. ESBL genes in faecal samples are detected by PCR and confirmed with culture. ;Timepoint(s) of evaluation of this end point: Day 21	—

Measure

Time frame

Main Objective: To investigate the efficacy of Anti-ESBL IgY compared to placebo in order to eradicate intestinal carriage with ESBL Klebsiella pneumoniae and E coli.;Secondary Objective: Efficacy: absence/recurrence of ESBL, i.e. negative faecal sample during and after treatment Safety/tolerability: in terms of adverse events ;Primary end point(s): The primary endpoint is eradication of faecal carriage with ESBL-producing K. pneumoniae and/or E. coli at Day 21 (end of treatment) and is measured as the proportion of ESBL negative subjects at Day 21. Eradication is defined as both samples negative in a duplicate sample. ESBL genes in faecal samples are detected by PCR and confirmed with culture. ;Timepoint(s) of evaluation of this end point: Day 21

—

Secondary

Measure	Time frame
Secondary end point(s): • The proportion of negative ESBL in faeces Day 7, 28 and both Day 21 and 28, irrespectively • Time from treatment assignment to first ESBL negative • Morbidity: days at inpatient ward • Safety: Adverse events, tolerability;Timepoint(s) of evaluation of this end point: See above	—

Countries

Sweden

Contacts

Public ContactElin Nilsson, Project Manager

Uppsala University

elin.nilsson@medsci.uu.se+460186113091

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026