Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04764058
Status:
UNKNOWN
Last Update Posted:
2021-02-21
First Post:
2021-02-15
Brief Title:
Efficacy and Safety of Colistin Based Antibiotic Therapy
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Efficacy and Safety of Colistin Based Antibiotic Therapy for Multidrug Resistant Gram Negative Infections in Pediatric Intensive Care Unit
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
The main outcome measure is clinical and microbiological responses to therapy
The secondary outcome is the occurrence of adverse events during Colistin combination treatment
Detailed 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 Childrens 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 50000-75000 IUkgday in three divided doses infused IV in 10mL normal saline over 30 minutes with IV Imipenem in doses of 15 to 25 mgkg every 6 hours212224 Colistin formulation consists of 2 million IU per vial Group II Thirty patients will receive IV Imipenem in doses of 15 to 25 mgkg every 6 hours 2224
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-ImipenemCilastatin as a combination or ImipenemCilastatin 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 andor conclusion of treatment failure and or success was based upon the worsening andor improvement of the patients parameters and their situation including the results of the microbiological examination before and after the intervention
Design of the study
- Prospective Randomized interventional study
Setting
- The study will be conducted in the pediatric surgery intensive care unit in Childrens 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 50000-75000 IUkgday in three divided doses infused IV in 10mL normal saline over 30 minutes with IV Imipenem in doses of 15 to 25 mgkg every 6 hours212224 Colistin formulation consists of 2 million IU per vial Group II Thirty patients will receive IV Imipenem in doses of 15 to 25 mgkg every 6 hours 2224
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-ImipenemCilastatin as a combination or ImipenemCilastatin 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 andor conclusion of treatment failure and or success was based upon the worsening andor improvement of the patients parameters and their situation including the results of the microbiological examination before and after the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None