Phage therapy for the decolonization of specific multidrug resistant bacteria in high-risk patients

Building a decolonization model using phages against KPC producing Klebsiella pneumoniae in high risk patients: a prospective feasibility and proof of concept study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-9f3whw9

Enrollment

Unknown

Registered

2025-07-04

Start date

2025-09-01

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Drug Resistance, Bacterial

Interventions

This study is a single arm non-randomized and non-binded stuy that will inlcude a total of 15 patients. Patients will receive a combination of bacteriophages during 14 days. The total phage-intake wil

E02.095.841

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients of both genders; active hematological or oncological condition; use of immunosuppressive medications; history of infection by Klebsiella pneumoniae producing Klebsiella pneumoniae carbapenemase with high risk of recurrence; planned surgery with high risk of infectious complication; sufficient time window to administer at least 7 days of phage therapy; positive rectal swab for Klebsiella pneumoniae producing Klebsiella pneumoniae carbapenemase; availability of a combination of phages active against the patient’s isolate; age over 18 years; signed informed consent from the patient

Exclusion criteria

Exclusion criteria: Patients without informed consent signed; pregnancy; breastfeeding; hemodynamic instability; any other acute and severe organ dysfunction; antibiotic treatment

Design outcomes

Primary

Measure	Time frame
We expect the intestinal eradication of Klebsiella pneumoniae carbapenemase-producing Klebsiella pneumoniae in rectal swabs measured by quantitative polymerase chain reaction and bacterial culture 14 days after the end of treatment in at least 20% of patients.	—

Secondary

Measure	Time frame
We expect the study to be feasible, defined as at least 80% of patients adhering to the treatment for at least 7 days;We expect lowering the Klebsiella pneumoniae carbapenemase-producing Klebsiella pneumoniae load on rectal swabs over time and up to three months after the last dose of phages measured by bacterial culture and quantitative polymerase chain reaction;We expect the phage treatment to be safe, safety and tolerability of the phage treatment will be assessed up to 14 days after the last dose by laboratory monitoring and regular clinical assessments;We expect the presence of phages in feces after oral administration measured through the double-layer agar method and spot-test assays;We expect the development of Klebsiella pneumoniae carbapenemase producing Klebsiella pneumoniae mutants resistant to phages, that will be verified by genetic sequencing and phage sensitivity testing;We expect the development of antibodies against the administered phages, measured via an antibody neutralizing assay;We expect changes in the intestinal microbiome of patients after phage treatment that will be investigated through metagenomic sequencing of fecal samples	—

Measure

Time frame

We expect the study to be feasible, defined as at least 80% of patients adhering to the treatment for at least 7 days;We expect lowering the Klebsiella pneumoniae carbapenemase-producing Klebsiella pneumoniae load on rectal swabs over time and up to three months after the last dose of phages measured by bacterial culture and quantitative polymerase chain reaction;We expect the phage treatment to be safe, safety and tolerability of the phage treatment will be assessed up to 14 days after the last dose by laboratory monitoring and regular clinical assessments;We expect the presence of phages in feces after oral administration measured through the double-layer agar method and spot-test assays;We expect the development of Klebsiella pneumoniae carbapenemase producing Klebsiella pneumoniae mutants resistant to phages, that will be verified by genetic sequencing and phage sensitivity testing;We expect the development of antibodies against the administered phages, measured via an antibody neutralizing assay;We expect changes in the intestinal microbiome of patients after phage treatment that will be investigated through metagenomic sequencing of fecal samples

—

Countries

Brazil

Contacts

Public ContactAna Gales

Escola Paulista de Medicina - Univeridade Federal de São Paulo

ana.gales@unifesp.br+55(11)998985561

Outcome results

None listed

Source: REBEC (via WHO ICTRP)