Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparative Clinical Study Between Colistin-Tigecycline Combined Therapy Versus Colistin-Meropenem Combined Therapy in Treatment of Blood Stream Infections With Multidrug-Resistant Klebsiella Pneumoniae

NCT04489459

Treatment of Blood Stream Infections Due to Multidrug-Resistant Klebsiella Pneumoniae

UNKNOWN PHASE4

Comparing Tigecycline Vs. Colistimethate in CNS Infections

NCT06702943

Central Nervous System Infections

NOT_YET_RECRUITING

Different Dosing Strategies of Colistin in Multidrug-Resistant Gram-Negative Bacilli Infections

NCT06843668

Critical Ill Patients Multi Drug Resistant

RECRUITING PHASE2/PHASE3

Efficacy and Safety of Colistin Based Antibiotic Therapy

NCT04764058

Septicemia Bacterial Infections

UNKNOWN PHASE1/PHASE2

Population Pharmacokinetic Study of Colistin in Patients Infected With Multiresistant Gram-negative Bacteria

NCT01060891

Gram-negative Bacteria

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infection in ICU

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Colistin

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.

Group Type ACTIVE_COMPARATOR

Colistimethate Sodium

Intervention Type DRUG

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

Tigecycline

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.

Group Type ACTIVE_COMPARATOR

Tigecycline

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Colistimethate Sodium

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

Intervention Type DRUG

Tigecycline

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

colistin tygcil

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No