Skip to content

A study to observation patients with cancer who develop fever on chemotherapy due to low white cell count

Febrile Neutropenia in the Oncological setting: A prospective observational study - FN-ONE STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/09/036930
Enrollment
1000
Registered
2021-09-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D701- Agranulocytosis secondary to cancer chemotherapy Health Condition 2: R509- Fever, unspecified Health Condition 3: D709- Neutropenia, unspecified

Interventions

Intervention1: NA: NA Control Intervention1: NA: NA

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a. Subjects with all age group will be included for the study. b. Receiving chemotherapy for newly diagnosed or relapsed malignancy. c. Febrile neutropenia defined as fever (temperature >100.4 F on two occasions within a 12 hour period or 101°F once) during neutropenia (absolute neutrophil count

Exclusion criteria

Exclusion criteria: a. Non-chemotherapy related febrile neutropenia. b. Fever due to underlying malignancy c. Non neutropenic fever

Design outcomes

Primary

MeasureTime frame
To evaluate the outcomes of febrile neutropenia viz resolution of fever, progression to hemodynamic instability, ICU transfer and death.Timepoint: From the time of enrollment till resolution of the febrile neutropenia episode or death of the patient, whichever earlier.

Secondary

MeasureTime frame
1. To evaluate the incidence of MDR organism (Details in Appendix-2) 2. To evaluate baseline prognostic factors for outcome. 3. To evaluate patterns of care (escalation or de-escalation) and outcome. 4. To evaluate success to antibiotics and delay in chemotherapy. Timepoint: Daily monitoring of from the enrollment, till recovery from infection, fever and/or neutropenia whichever happens earlier

Countries

India

Contacts

Public ContactDr Lingaraj Nayak

Tata Memorial Hospital

lingarajnayak86@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026