Efficacy and Safety of Colistin Based Antibiotic Therapy
NCT04764058 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2021-02-21
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.
Conditions
- Septicemia
- Bacterial Infections
Interventions
- DRUG
-
Tienam 500
Imipenem and cilastatin sodium
- DEVICE
-
Infusion
Health caregivers give the drug to the patients and monitoring the infusion rate
Sponsors & Collaborators
-
Ain Shams University
lead OTHER
Principal Investigators
-
AHMED S ATTIA · Heliopolis University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-09-01
- Primary Completion
- 2019-09-01
- Completion
- 2021-09-01
Countries
- Egypt
Study Locations
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