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