Comparison of the safety and efficacy of empirical use of colistin monotherapy versus colistin plus minocycline combination therapy in ventilator associated pneumonia(VAP) due to carbapenem resistant gram negative organism infection - a randomized controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To compare the mortality rate in both the study groups
研究概览
简要总结
Colistin resistance is an emerging issue in gram-negative bacterial infections, especially in ventilator-associated pneumonia(VAP) patients. Indian hospitals many a time need to start antimicrobial therapy empirically i.e. before a culture sensitivity report is available. The mortality rate at tertiary care referral hospitals is close to 50 % due to sepsis and compromised oxygen saturation. To find the best regimen, we are planning a single-centre, two-arm, prospective, double-blind, parallel-group, randomized controlled trial comparing the efficacy and safety of colistin monotherapy versus colistin plus minocycline combination therapy. It will be addressed in a randomized controlled trial manner by using computer-generated randomization codes. The outcome assessment will be blinded. It will happen at the end of two years by studying 200 patients at the ICUs of the Department of Internal Medicine, Pulmonology, PGIMER Chandigarh. The study will randomly allocate the VAP[ both clinical diagnosis & Lab confirmed] patients into monotherapy and combination therapy arms with other background medications. The clinician in charge can taper the antimicrobial therapy as per clinical and laboratory responses. Patients will be followed up during their hospital stay and till day 28 of study medication initiation. We will assess the 28 mortality in both arms besides other secondary endpoints like time on ventilator, duration of ICU and hospital stay, microbiological clearance, and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •Hospitalized and receiving mechanical ventilation for at least 48 hours at the time of study enrolment
- •Patient with VAP diagnosis as per hospital protocol definition#
- •Endotracheal aspirate sample sent for culture and sensitivity prior to study drug initiation.
- •Legally acceptable representative(LAR) providing informed consent, and willing to give follow up.
排除标准
- •History of hypersensitivity to any of the two antimicrobials of the study (colistin/ minocycline).
- •Received colistin/polymyxins therapy or minocycline for a minimum time period of 72 hours within 96 hours prior to randomization
- •Renal insufficiency.
- •Patients included in another clinical trial in the past three months.
- •Pregnant or nursing woman
- •Patients with neutropenia (WBC < 500 cells/mm3)
- •Presence of primary infection at other sites, e.g., osteomyelitis, endocarditis, prosthetic joint infection, meningitis, or central nervous system infection.
结局指标
主要结局
To compare the mortality rate in both the study groups
时间窗: Day 0, day 3, Day 7, Day 10, Day 14, and Day 28
次要结局
- To compare two study groups for-(A] Adverse events)
研究者
Prof Samir Malhotra
PGIMER Chandigarh