Efficacy and Safety of Colistin Based Antibiotic Therapy

• Status: Enrolling by invitation
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Cilastatin, Imipenem Drug Combination

Criteria

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.