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Active, Not Recruiting

NCT Number: NCT06893835

Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pharmacy

Cairo, Egypt

About this study

Study will be in Beni-Suef university hospital. 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 and group 2 contains 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • 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.

Treatment and study plan

colistimethate sodium

Drug

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

Other names: colistin

tigecycline

Drug

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

Other names: tygcil

Primary outcomes

  1. comparison clinical success between colistin and tigecycline

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline for Multi-Drug Resistant Gram Negative Bacteria

Acronym: MDRS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 25, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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