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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04764058
Other study ID # 210
Secondary ID
Status Enrolling by invitation
Phase Phase 1/Phase 2
First received
Last updated
Start date September 1, 2017
Est. completion date September 1, 2021

Study information

Verified date February 2021
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Patients and Methods Design of the study: - Prospective, Randomized, interventional study. Setting: - The study will be conducted in the pediatric surgery intensive care unit in Children's Hospitals, Ain Shams University, Cairo, Egypt. Subjects: - Pediatric patients admitted in pediatric surgery intensive care unit. Inclusion criteria: All children with culture-proven nosocomial infections due to multidrug resistance gram-negative organisms Exclusion criteria: 1. Patients who started on Colistin treatment outside the pediatric surgery intensive care unit and transferred to the unit afterward will be excluded. 2. Patients who will receive <6 doses of intravenous Colistin will be excluded. 3. Patients received Imipenem or Colistin-Imipenem compination as empirical antibiotic. Methodology: - Sixty pediatric patients admitted to the pediatric surgery intensive care unit will be enrolled in the study and will be randomly assigned to either Group I or Group II Group I: 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 hoursĀ¬.21,22,24 Colistin formulation consists of 2 million IU per vial. Group II: Thirty patients will receive IV Imipenem in doses of 15 to 25 mg/kg every 6 hoursĀ¬. 22,24 For all patients the following data will be collected: 1. Demographic data (age, gender, weight). 2. The risk factors for nosocomial infections. 3. Pediatric surgery intensive care unit stay. 4. Type of surgeries performed. 5. Site of isolation of organisms. 6. The dose and duration of therapy. 7. Serum creatinine levels will be assessed at baseline, once weekly and at the end of Colistin combination therapy. 8. Nephrotoxic co-medication monitoring. 9. Clinical (resolution of signs and symptoms of infection) and 10. microbiological (bacteriologic responses) outcomes will be evaluated during treatment and at the end of the treatment. According to the inclusion and exclusion criteria, the demographic data for the intended ICU patients was collected, then the sample was withdrawn from the infected site to be cultured on specific culture media (such as blood agar, MacConkey agar, Chocolate agar), and identification of the isolated microorganism was detected by biochemical tests and Vitek-2 compact system whenever required. Antimicrobial sensitivity to Colistin was tested using the micro broth dilution method, in order to be evaluated in Colistin therapy. After culture-proven, the drug was given, either IV Colistin-Imipenem/Cilastatin as a combination or Imipenem/Cilastatin as a monotherapy. Throughout this step, the hemodynamic parameters were measured during the process of treatment, without neglecting the serum creatinine level to detect any nephrotoxicity. We assure the right drug handling, dosing, dispensing, and monitoring. At the end of the treatment, the duration and length of PICU stay were recorded. The decision and/or conclusion of treatment failure and/ or success was based upon the worsening and/or improvement of the patients' parameters and their situation including the results of the microbiological examination before and after the intervention


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 60
Est. completion date September 1, 2021
Est. primary completion date September 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All children with culture proven nosocomial infections due to multidrug resistance gram-negative organisms Exclusion Criteria: - 1. Patients who started on Colistin treatment outside the pediatric surgery intensive care unit and transferred to the unit afterward will be excluded. 2. Patients who will receive <6 doses of intravenous Colistin will be excluded. 3. Patients received Imipenem or Colistin-Imipenem compination as empirical antibiotic.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tienam 500
Imipenem and cilastatin sodium
Device:
Infusion
Health caregivers give the drug to the patients and monitoring the infusion rate

Locations

Country Name City State
Egypt Ain Shams Univesity Hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hemodynamic Parameters Measurement ,heart beating rate. the efficacy and safety of antibiotic combination containing Colistin. We will monitor the heart beating rate. 2 year
Primary Hemodynamic Parameters Measurement ,body temperature the efficacy and safety of antibiotic combination containing Colistin. We will monitor the body temperature 2 year
Primary Hemodynamic Parameters Measurement ,respiratory rate. the efficacy and safety of antibiotic combination containing Colistin. We will monitor the respiratory rate. 2 year
Primary Hemodynamic Parameters Measurement ,blood pressure the efficacy and safety of antibiotic combination containing Colistin. We will monitor the blood pressure 2 year
Primary 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
Primary 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
Primary Hemodynamic Parameters Measurement ,serum creatinine the efficacy and safety of antibiotic combination containing Colistin. We will monitor the serum creatinine 2 year
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