Early discontinuation of antibiotics before white blood count recovery in high risk febrile neutropenia episodes with undocumented infection in children- A non inferiority study,

Early antibiotic termination before marrow recovery in high risk febrile neutropenia episodes without clinically and microbiologically documented infection in children aged 1 month to 18 years: An unblinded non inferiority randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/103506

Enrollment

160

Registered

2026-02-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: C910- Acute lymphoblastic leukemia [ALL] Health Condition 2: C920- Acute myeloblastic leukemia

Interventions

Intervention1: Early antibiotics termination before marrow recovery after being afebrile for 48 hours: In high risk febrile neutropenia episodes antibiotics will be started and continued till they bec

Eligibility

Inclusion criteria

Inclusion criteria: High-risk febrile neutropenia episode in children aged from 1 month to 18 years without any microbiologically or clinically documented infection. Afebrile for 48 hours without marrow recovery

Exclusion criteria

Exclusion criteria: Children referred to or discharged to other Institutes

Design outcomes

Primary

Measure	Time frame
To compare the proportion of febrile neutropenia episodes developing fever recurrence with early (before marrow recovery and after 48 hrs of afebrile period) and standard antibiotic termination (after marrow recovery)Timepoint: Till marrow recovery	—

Secondary

Measure	Time frame
To compare the rate of mortality in children with early (before marrow recovery) and standard antibiotic terminationTimepoint: Till marrow recovery	—

Countries

India

Contacts

Public ContactDr Jaikumar

Jawaharlal institute of post graduate medical Education and Research JIPMER

gr_jaikumar@yahoo.in8196800157

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026