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临床试验/NCT07524920
NCT07524920尚未招募2 期

Comparing Efficacy and Safety of (Meropenem + Colistin) Versus (Imipenem/Cilastatin + Tigecycline) on Eradication of Multi-Drug Resistance Bacteria

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Efficacy of treatment, (Laboratory Investigation): PCT

研究概览

简要总结

This study aims to compare the efficacy and safety of two antibiotic combinations (Colistin + Meropenem) vs (Imipenem/cilastatin+ Tigecycline) in the treatment of adults with MDR gram-negative infections.

详细描述

Antimicrobial resistance is rapidly becoming a global focus of attention, especially with the rising number of microorganisms resistant to available antimicrobials. It encompasses both the gram-positive and gram-negative bacteria, with global prevalence rates of 60% or more.

Multidrug-resistance is described as acquired non-sensitivity to one or more agents in at least three groups of antimicrobials. This kind of resistance essentially predominates in hospitals , as The Centers for Disease Control and Prevention (CDC) declared that worldwide increasing infection rates with resistant pathogens strikingly endanger our healthcare systems creating both negative universal economic effects and a therapeutic challenge for clinicians hence delaying proper antibiotic therapy and increasing mortality rates.

A retrospective study on the prevalence and antimicrobial susceptibility profile of multidrug-resistant bacteria among intensive care units' patients at Ain Shams University Hospitals in Egypt showed that the majority of pathogens were isolated from blood cultures, with higher prevalence of gram-negative isolates, and Klebsiella sp. being the most common pathogen isolated followed by E. coli.

For complicated infections or hemodynamically unstable patients, it's recommended to administer polymyxins plus another agent to which organism has demonstrated susceptible MIC (like tigecycline, aminoglycosides, IV fosfomycin) or high dose carbapenems if MIC < 16, Ceftazidime-avibactam alone if in-vitro susceptibility has been demonstrated or in combination with aztreonam if synergy test is demonstrating zone of inhibition., Tigecycline is approved for intra-abdominal infection and skin -soft tissue infection- but not highly recommended for blood stream infection or pneumonia as a standalone agent. Colistin is preferred over polymyxin B for UTI as a single agent for uncomplicated infections.

All the suggested treatments are provided as combinations not as a single agent because of the failure of single antibiotic regimens in many trials. and there are also many studies which were based on combination therapy with a few antibiotics showed certain activity against MDR bacteria including colistin, Imipenem/cilastatin , Meropenem, rifampicin, sulbactam and tigecycline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult and elderly patients (aged 18-85 years)
  • With Clinical and microbiological evidence of infection due to positive or negative multi-drug resistant bacterial culture whatever the cause of patient hospital admission from the beginning.
  • Immunocompromised patient With Clinical and microbiological evidence of infection due to positive or negative multi-drug resistant bacterial culture

排除标准

  • • History of prior hypersensitivity to the study drugs.
  • Recent fits or CNS events like seizures.
  • Pregnancy and lactation.
  • Bacterial MDR culture but sensitive to one of the antibiotics used in the study

研究组 & 干预措施

"colistin" and "meropenem"

Experimental

30 patients will receive a combination of "Meropenem" and "colistin", normal dose of Meropenem is 2gm/8hrs and normal dose of colistin is loading dose 9 million units once followed by 5million units/12hrs for about 5-14 days period.

干预措施: "colistin" and "meropenem" (Drug)

"Imipenem/cilastatin" and "Tigecycline"

Experimental

30 patients will receive a combination of "Imipenem/cilastatin" and "Tigecycline", normal dose of Imipenem/cilastatinis 500mg or 1gm every 6 to 8 hrs and normal dose of Tigecyclineis 200 mg loading dose once followed by 100mg/12hrs as maintenance dose for about 5-14 days period.

干预措施: "Imipenem/cilastatin" and "Tigecycline" (Drug)

结局指标

主要结局

Efficacy of treatment, (Laboratory Investigation): PCT

时间窗: on day 3 , 7 , 11 , 15 , 19 , 23 , 27

to check on the success of the antibiotic combination in decreasing Procalcitonin value (PCT) ng/ml

Efficacy of Treatment (Laboratory Investigation): Complete blood picture (CBC)

时间窗: on day 1 , 3 , 5 , 7 , 9 , 11 ,13 ,15 , 17 , 19 , 21 , 23 , 25 , 27 , 29

1- Complete blood picture (CBC) to check on the success of the antibiotic combination in decreasing the total leucocytic count (TLC)10\^3/ul and neutrophiles count (NEUT)10\^3/ul.

Efficacy of treatment, (Laboratory Investigation): CRP

时间窗: on day 3 , 6 , 9 , 12 , 15 , 18 , 21 , 24 , 27 , 30

to check on the success of the antibiotic combination in decreasing C-reactive protein value (CRP)mg/l

Efficacy of treatment, Bacteriology test (culture)

时间窗: on day 4 , 11 , 18 , 25

bacteriology culture is done from the site of infection

Efficacy parameters, Symptoms

时间窗: on day 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30

it differs according to source of infection as it could be fever or others according to the source of infection

Emergent adverse event by BUN (mg/dl) , Sr.Cr (mg/dl) and uric acid (mg/dl)

时间窗: on day 1,3,5,7,9,11,13,15,17,19,21,23,25,27,29

to check on BUN (mg/dl) , Sr.Cr (mg/dl) and uric acid (mg/dl) values as a kidney function monitoring measures to decide if there is a need for antibiotics dose adjustments

Emergent adverse event by ALT and AST

时间窗: on day 1,3,5,7,9,11,13,15,17,19,21,23,25,27,29

to check on ALT (IU/L) , AST (IU/L) values as a liver function monitoring measures to decide if there is a need for antibiotics dose adjustments

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rana Sayed Fouad

Associate professor

Ain Shams University

研究点 (1)

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