NCT03950544

Brief Summary

The infection of carbapenem resistant klebsiella pneumoniae (CRKP) is increasingly serious.Based on the early experimental basis and relevant research background,this study intends to separate and purify the CRKP from the bronchoalveolar lavage fluid (BALF) of the clinical patients.Designed by checkerboard assay and time-kill assay(TKA)，this study can explore the best combination therapy based on carbapenems.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 15, 2019

Status Verified

April 1, 2019

Enrollment Period

1.7 years

First QC Date

October 30, 2018

Last Update Submit

May 11, 2019

Conditions

Antibiotic Resistant Infection

Outcome Measures

Primary Outcomes (1)

  • the fractional inhibitory concentration index (FICI)

    By checkerboard method and microdilution broth method,get the minimal inhibitory concentration (MICS) of two antibiotics,then calculate the fractional inhibitory concentration (FIC) index according to MIC results. Evaluation index: FIC=0.5 , coordinating effect. 0.5 \< FIC \<1, adding effect; 1 \< FIC \<2, irrelevant.

    24hours-36hours

Secondary Outcomes (1)

  • the time-kill assay (TKA)

    36hours-48hours

Study Arms (1)

only meropenem therapy,

EXPERIMENTAL

this group is only meropenem therapy as a single antibiotic treatment

Drug: FosfomycinDrug: TigecyclineDrug: Polymyxin B

Interventions

FosfomycinDRUG

Fosfomycin and meropenem

Also known as: meropenem
only meropenem therapy,
TigecyclineDRUG

Tigecycline and meropenem

Also known as: meropenem
only meropenem therapy,
Polymyxin BDRUG

Polymyxin B and meropenem

Also known as: meropenem
only meropenem therapy,

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age from 18 to 90.
  • infected with CRKP firstly .

You may not qualify if:

  • APACHE II score \> 35
  • Vital signs are unstable
  • Unable to tolerate fiberoptic bronchoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai 10th people's hospital

Shanghai, Shanghai Municipality, 201300, China

RECRUITING

Related Publications (1)

  • Du Y, Mu S, Liu Y, Yuan Y, Zhu Y, Ma L, Wang Q, Zhu Z, Liu Y, Wang S. The Genomic Characterization of KPC-Producing Klebsiella pneumoniae from the ICU of a Teaching Hospital in Shanghai, China. Infect Drug Resist. 2022 Jan 11;15:69-81. doi: 10.2147/IDR.S343673. eCollection 2022.

    PMID: 35046672DERIVED

MeSH Terms

Interventions

FosfomycinMeropenemTigecyclinePolymyxin B

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsThienamycinsCarbapenemsbeta-LactamsLactamsAmidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsPolymyxinsPeptides, CyclicMacrocyclic CompoundsLipopeptidesLipidsAntimicrobial Cationic PeptidesPeptidesAmino Acids, Peptides, and ProteinsAntimicrobial PeptidesPore Forming Cytotoxic ProteinsMembrane ProteinsProteins

Study Officials

  • Li Hua, master

    Shanghai 10th People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ma Lao, master

CONTACT

861353243789613532437896@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 30, 2018

First Posted

May 15, 2019

Study Start

January 1, 2019

Primary Completion

August 31, 2020

Study Completion

December 31, 2020

Last Updated

May 15, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)