FORMAT FOR APPLICATION TO THE SCIENTIFIC COMMITTEE BOARD OF HCG

Investigator Initiated study on ( Title ) :Value of C- Reactive Protein as a marker for infection in paediatric cancer patients with fever.

1) Date of submission

Scientific Committee meeting date: 29/07/2016

Scientific Committee Revisions reconsideration date

2) Category of study -Retrospective and Prospective observational studies.

3) If part of a Thesis – which is the University or Body , for submission.

4) Category of Principal Researcher - Research Student – P.E.S Institute Of Technology.

5) If Principal investigator is external,

External Guide

Co Guide from HCG.

If Principal investigator is internal,

Guide from HCG :

Dr. IntezarMehdi

Co Guide :

Dr. Suma T L

Dr. AmitGalgali

6) List of Co Investigators and their signature

7) Head of Department Signature

8) Any special request – Waiver of Informed Consent / Expedited Clearance

9) If funded – Funding Organisation. Details of funding.

10) Synopsis of Study :To study the value of CRP as a marker for infection in pediatric cancer patients presenting with fever. Infections that develop in people with cancer or are getting cancer treatment is more serious than those in healthy people. Use of infection biomarkers like, CRP that resolve the origin of fever and predict infection at early stage in patients is important. CRP levels will be evaluated to see if they predict the occurrence of infection in patients getting treatment.

11) Study details format

Aims, Objectives, Review of Literature

Title :To study the value of CRP as a marker for infection in pediatric cancer patients presenting with fever.

Objectives:

Primary Objective:

  • To study the value of CRP as a marker for infection in pediatric cancer patients presenting with fever.

Secondary Objective:

  • To study if CRP levels act as a marker for infection in febrile patients during the treatment.

Review of Literature:

Shereen Mohamed EL-Maghraby et al, did a prospective study on febrile neutropenic children with hematologic malignancies. In this study, neutropenic children with febrile episodes were classified into 2 groups, a group with unexplainable fever (group 1 , n= 26) and another group with blood culture positive (group II, n=59). Clinically, local sites of infection were encountered in 39 cases(49.5%), whereas a positive blood culture was detected in 20 cases. CRP ≥90 mg/L was significantly associated with chemotherapy-related neutropenia and fever owing to bacteremia.The sensitivity, specificity of CRP, MCP-1 & IL-8 were found to be (70%,73%),(64%,92%),(71%,77%). Combining 2 or 3 markers improved the diagnostic performance of the tests.

Karin G. E. Miedema et al, did a prospective study on pediatric cancer patients with infection. A total of 43 febrile neutropenic episodes in 29 patients were enrolled in the study. In 17 of the 43 febrile neutropenic episodes, plasma was also collected 24–48h after presentation with febrile neutropenia. The influence of mucositis on the levels of CRP, IL-8 was studied in a total of 26 episodes in 8 patients in the presence and in the absence of mucositis. Five of the eight patients were female (63%). The age of the included patients ranged from one to 15 years. CRP levels did not differ significantly in bacterial infection. The sensitivity & specificity of CRP at presentation of fever was (69%, 62%). According to this study, IL-8 is the best marker for the early detection of bacterial infection. The sensitivity at admission with febrile neutropenia is shown to be respectably high (92%). In this study it is shown that CRP, which is widely used as detector for bacterial infections, is actually a poor discriminatory marker. IL-8 is more useful as marker for the early detection of bacterial infections, and IL-8 in combination with clinical parameters or PCT might be even more useful.

NarendraChaudhary et al, did a prospective study to evaluate the usefulness of interleukin-6 (IL-6) and C-reactive protein (CRP) at the onset of febrile neutropenia and 72 hours later. All episodes of febrile neutropenia were divided in 3 study groups—microbiologically documented infection (MDI), clinically documented infection (CDI), and fever of unknown origin (FUO). Three outcome groups were defined as those responding to first-line antibiotics (R1), those responding to second-line antibiotics (R2), and those requiring antifungal therapy (RAF). On day 1, IL-6 level was significantly lower in FUO group compared with CDI+MDI groups combined. Rise in CRP on day 3 was highly significant in MDI group from other 2 groups. CRP also increased significantly on day 3 in RAF and R2 groups than in R1 group. Low level of IL-6 may help differentiate patients with FUO from those with documented infections. A rising CRP is indicative of serious infection.

Material and Methods, Method of analysis.

STUDY DESIGN:

Retrospective and prospective observational study.

STUDY DURATION:

This Retrospective study would be carried out over a period of 12 months from May 2016 to May 2017 and Prospective study over a period of 2months from June 2017 to July 2017.

INCLUSION CRITERIA:

  • All inpatients and out patients who visit Paediatric Oncology department during the study period and fit into criteria of fever & infection.
  • Patients who are willing to give consent for this study.

EXCLUSION CRITERIA:

  • Patients making IP and OP visit and not fitting the criteria for fever & infection.

Study Procedure:

Data will be collected from the investigation flow chart of the patients before & after the episodes of fever, infection. Comparative study will be done on CRP levels of patients during & after the treatment.

Data collection form :

NAME : AGE: SEX: WEIGHT: HEIGHT:

UHID NO: BSA: DOA: DOD:

LAB INVESTIGATIONS

LIVER FUNCTION TEST:

CRP :

ASSESSMENT FOR FEVER AND INFECTION:

HIGH RISK :

LOW RISK:

STUDY PROTOCOL:

Patient Name / Gender / Age / Diagnosis / CRP level during fever / CRP level during treatment (fever) / CRP level after episode of fever

Need for study:

This study deals with the variation of CRP levels in pediatric cancer patients having infection during or after the treatment and presenting with fever, to know the value of CRP levels as a marker for the infection in febrile patients.

12) Signature of Principal Investigator, email id and tel no.

Apurva M Jagateri