Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline

NCT06893835 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: Multidrug resistance
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Objective from this study to compare the clinical outcomes and safety between colistin and tigecycline for multi-drug resistant gram negative bacteria.

Conditions

Infection in ICU

Keywords

colistin; Tigecycline; renal impairment

Outcome Measures

Primary Outcomes (1)

• comparison clinical success between colistin and tigecycline

  the disappearance of clinical signs and symptoms as normalization of leukocyte counts and resolution of fever after receiving colistin and tigecycline

  6 months

Study Arms (2)

Colistin

ACTIVE COMPARATOR

Intravenous colistin 300 mg colistin base activity (CBA) as loading dose, followed by 2.5-5mg/kg/day of CBA in 2 divided doses as a maintenance dose. Reconstitute each vial of CBA with 2 ml of sterile water for injection, swirl gently. further dilute in normal saline.

Drug: Colistimethate Sodium

Tigecycline

ACTIVE COMPARATOR

intravenous tigecycline100 mg single dose as loading dose, followed by 25-50 mg every 12 hours maintenance dose. add 5.3 ml normal saline to each 50 ml vial. swirl gently. further dilution to final concentration does not exceed 1mg/ml.

Drug: Tigecycline

Interventions

Colistimethate Sodium DRUG

compare the clinical outcomes and safety between colistin and tigecycline for multi-drug-resistant gram-negative bacteria.

Also known as: colistin

Colistin

Tigecycline DRUG

compare the clinical outcomes and safety between colistin and tigecycline for multi-drug-resistant gram-negative bacteria.

Also known as: tygcil

Tigecycline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study will include
• adult patient (male, female)
• age from 18 to 70 years
• Patients admitted to intensive care unit in study period (six months) who received intravenous colistin or tigecycline as antimicrobial drug for treatment their MDR gram negative infection.

You may not qualify if:

• Patient admitted to intensive care unit younger than 18 years or older than 70 years.
• Liver transplantation patients.
• Patients are chronic kidney disease (CKD on hemodialysis or baseline creatinine clearance (crcl) \< 10 ml/min (estimated by Cockcroft Gault equation).
• Patients received renal replacement therapy before or during admission.
• Patient is on any other nephrotoxic drug (vancomycin, aminoglycosides, NSAIDs, cyclosporine, amphotericin B, etc.).
• Pregnant and lactating women.
• Patients refused the consent of the study.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Pharmacy

Cairo, Egypt

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

colistinmethanesulfonic acid; Colistin; Tigecycline

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Shimaa N Abd elfatah, PhD

  Beni-Suef University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Model Details: Group I: 66 patients received intravenous colistin 300 mg colistin base activity (CBA) as loading dose, followed by 2.5-5mg/kg/day of CBA in 2 divided doses as a maintenance dose in intensive care unit to treat their MDR infection. Group II: 66 patients received intravenous tigecycline100 mg single dose as loading dose, followed by 25-50 mg every 12 hours maintenance dose in intensive care unit to treat their MDR infection.

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 25, 2025
• Study Start: December 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-02

Locations

EG (1)