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临床试验/CTRI/2024/07/071485
CTRI/2024/07/071485尚未招募不适用

Assessment of Infections, Antimicrobial Prescription Pattern And Survival Rate Among The Head And Neck Cancer Patients: A Retrospective Study

未提供1 个研究点 分布在 1 个国家目标入组 369 人开始时间: 2024年8月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
369
试验地点
1
主要终点
This study will provide a summary of prescription pattern of antimicrobial agents, prevalence of infections, antimicrobial resistance and survival status of the Head and Neck Cancer patients.

研究概览

简要总结

INTRODUCTION

HNC is the malignancy of head and neck region including oral cavity, nasopharynx, oropharynx,

hypopharynx and also larynx .The main risk for these types of cancer include tobacco, alcohol use,

HPV(Human Papilloma-virus) and the use of Pan Masala.Management for HNC include

chemotherapy, radiotherapy, immuno-therapy and surgery.Cancer patients are more susceptible to

infections than normal people as the cancer therapy reduces the immunity to fight infections.AMR is

when the micro-organisms develop the ability to overcome the drugs and its action to kill. Improper

prescription, poor sanitation, poor infection control in hospitals, lack of new antibiotics, incomplete

treatment and over usage of antibiotics has known to be the leading reason for AMR. So survival rate

of HNC patients is highly depended on the disease state as well as the infections persisting.

OBJECTIVES OF THE STUDY

Impact of infection on prognosis can be severe, potentially resulting in the death of patients who

could have otherwise be survived, to estimate the occurrence of infections among Head and Neck

cancer patients, to evaluate the antimicrobial prescription and resistance patterns among Head and

Neck cancer patients and to determine the survival status and cause of mortality among Head and

Neck cancer patients.

NEED FOR THE STUDY

Head and Neck cancer is one of the leading cancer among Indian populations which is generally

managed by Surgical therapy, Radiation therapy, Chemotherapy and Targeted/immunological

therapy either alone or in combinations.The disease as well as treatment of HNC/long stay

hospitalization makes patients more prone to infections.It has been reported that about 19% of HNC

patients suffers from infection. There is limited evidences on the prevalence of types of infections

and antimicrobial prescription among HNC.Thus we aim to assess the prevalence of infection,

antimicrobial prescription pattern and give insight to antimicrobial resistance among HNC. Further

we also aims to determine the survival status of HNC patients and their cause of death.

METHODOLOGY

It is a retrospective study where data of patients who is 18 years or above with advanced stage Head

and Neck Cancer undergone Chemo-radiation therapy, radiation therapy, targeted therapy or

immunological therapy in the Department of Radiation therapy and Oncology will be collected from

Medical Record Department of Justice K.S Hegde Charitable Hospital.

STATISTICAL ANALYSIS

The data will be analyzed using descriptive statistics (Mean, Standard deviations, frequency,

percentage, inter-quartile range) and inferential statistics (chi-square test, Pearson/Spearman

correlation).Data will be analyzed using log–rank and Kaplan-Meier test. Data will be analyzed by

multivariate COX proportional model and hazard ratio. P value <0.05 will be considered statistically

significant.

OUTCOME MEASURES

This study will provide a summary of Prevalence of infections, Prescription pattern of antimicrobial

agents, Prevalence of infections, Antimicrobial resistance and also the Survival status of HNC

patients.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All advanced stage HNC patients who are 18 years and above and were treated in the last 5 years in Justice KS Hegde Charitable Hospital 2)Cade sheets containing complete information of HNC patients 3)Patients who have received chemo radiation or radiotherapy.

排除标准

  • Participants with incomplete data in case files 2)Participants or caregivers who do not respond to phone calls.

结局指标

主要结局

This study will provide a summary of prescription pattern of antimicrobial agents, prevalence of infections, antimicrobial resistance and survival status of the Head and Neck Cancer patients.

时间窗: 8 months

次要结局

  • Infection will be correlated with the mortality among Head and Neck Cancer(8 months)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

E Resna Rathnakar

NGSM Institute of Pharmaceutical Sciences

研究点 (1)

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