NCT04764058

Brief Summary

To evaluate the efficacy and safety of antibiotic combinations containing Colistin in the treatment of children with multidrug-resistant gram negative infections admitted in the pediatric surgery intensive care unit. The main outcome measure is clinical and microbiological responses to therapy. The secondary outcome is the occurrence of adverse events during Colistin combination treatment.

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
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2017

Longer than P75 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

February 15, 2021

Last Update Submit

February 18, 2021

Conditions

SepticemiaBacterial Infections

Outcome Measures

Primary Outcomes (7)

  • Hemodynamic Parameters Measurement ,heart beating rate.

    the efficacy and safety of antibiotic combination containing Colistin. We will monitor the heart beating rate.

    2 year

  • Hemodynamic Parameters Measurement ,body temperature

    the efficacy and safety of antibiotic combination containing Colistin. We will monitor the body temperature

    2 year

  • Hemodynamic Parameters Measurement ,respiratory rate.

    the efficacy and safety of antibiotic combination containing Colistin. We will monitor the respiratory rate.

    2 year

  • Hemodynamic Parameters Measurement ,blood pressure

    the efficacy and safety of antibiotic combination containing Colistin. We will monitor the blood pressure

    2 year

  • Hemodynamic Parameters Measurement ,partial oxygen saturation pressure

    the efficacy and safety of antibiotic combination containing Colistin. We will monitor the partial oxygen saturation pressure

    2 year

  • Hemodynamic Parameters Measurement and Septic Markers, serum lactate

    the efficacy and safety of antibiotic combination containing Colistin. We will monitor the serum lactate

    2 year

  • Hemodynamic Parameters Measurement ,serum creatinine

    the efficacy and safety of antibiotic combination containing Colistin. We will monitor the serum creatinine

    2 year

Study Arms (2)

Montherapy

OTHER

Thirty patients will receive IV Imipenem in doses of 15 to 25 mg/kg every 6 hours

Drug: Tienam 500Device: Infusion

Combination

OTHER

Thirty patients will receive IV Colistin in dosages of 50,000-75,000 IU/kg/day in three divided doses, infused IV in 10mL normal saline over 30 minutes with IV Imipenem in doses of 15 to 25 mg/kg every 6 hours¬.21,22,24 Colistin formulation consists of 2 million IU per vial.

Drug: Tienam 500Device: Infusion

Interventions

Tienam 500DRUG

Imipenem and cilastatin sodium

Also known as: Meronem
CombinationMontherapy
InfusionDEVICE

Health caregivers give the drug to the patients and monitoring the infusion rate

CombinationMontherapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All children with culture proven nosocomial infections due to multidrug resistance gram-negative organisms

You may not qualify if:

  • \. Patients who started on Colistin treatment outside the pediatric surgery intensive care unit and transferred to the unit afterward will be excluded.
  • \. Patients who will receive \<6 doses of intravenous Colistin will be excluded.
  • \. Patients received Imipenem or Colistin-Imipenem compination as empirical antibiotic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams Univesity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

SepsisBacterial Infections

Interventions

Cilastatin, Imipenem Drug CombinationMeropenem

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

ImipenemThienamycinsCarbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsCilastatinCyclopropanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipidsDrug CombinationsPharmaceutical Preparations

Study Officials

  • AHMED S ATTIA

    Heliopolis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharmacist

Study Record Dates

First Submitted

February 15, 2021

First Posted

February 21, 2021

Study Start

September 1, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2021

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)