NCT03767283

Brief Summary

Klebsiella pneumoniae is an important pathogen that frequently causes nosocomial community-acquired and infections, including pneumonia, urinary tract infections, bloodstream infections, pyogenic liver abscesses, and septic shock. An emerging co-existence of carbapenems and fluoroquinolone resistance in Klebsiella pneumoniae is causing major difficulty in treating infections caused by such pathogen

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

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

December 5, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

July 5, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2021

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

December 5, 2018

Last Update Submit

January 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • effect of combined antibiotic therapy on resistance

    determination of minimum inhibitory concentration to antibiotics before and after combination

    1 year

Eligibility Criteria

Age2 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients with infections admitted to ICUs

You may qualify if:

  • admitted to intensive care unite

You may not qualify if:

  • healthy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

RECRUITING

Related Publications (4)

  • Al-Marzooq F, Mohd Yusof MY, Tay ST. Molecular Analysis of Antibiotic Resistance Determinants and Plasmids in Malaysian Isolates of Multidrug Resistant Klebsiella pneumoniae. PLoS One. 2015 Jul 23;10(7):e0133654. doi: 10.1371/journal.pone.0133654. eCollection 2015.

    PMID: 26203651BACKGROUND
  • Chang CY, Lin HJ, Chang LL, Ma L, Siu LK, Tung YC, Lu PL. Characterization of Extended-Spectrum beta-Lactamase-Carrying Plasmids in Clinical Isolates of Klebsiella pneumoniae from Taiwan. Microb Drug Resist. 2017 Jan;23(1):98-106. doi: 10.1089/mdr.2015.0212. Epub 2016 May 5.

    PMID: 27148814BACKGROUND
  • Worthington RJ, Melander C. Combination approaches to combat multidrug-resistant bacteria. Trends Biotechnol. 2013 Mar;31(3):177-84. doi: 10.1016/j.tibtech.2012.12.006. Epub 2013 Jan 18.

    PMID: 23333434BACKGROUND
  • Zhao JY, Zhu YQ, Li YN, Mu XD, You LP, Xu C, Qin P, Ma JL. Coexistence of SFO-1 and NDM-1 beta-lactamase genes and fosfomycin resistance gene fosA3 in an Escherichia coli clinical isolate. FEMS Microbiol Lett. 2015 Jan;362(1):1-7. doi: 10.1093/femsle/fnu018. Epub 2014 Dec 4.

    PMID: 25790496BACKGROUND

Central Study Contacts

Ismail Mohamed, proffesor

CONTACT

Sherine Ahmed, professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 6, 2018

Study Start

July 5, 2019

Primary Completion

June 10, 2021

Study Completion

December 7, 2021

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations