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This study will test if giving prophylactic antibiotics can reduce infections and improve safety for children with acute lymphoblastic leukemia during the early intensive phase of chemotherapy

A randomised control trial to determine the efficacy of antibiotic prophylaxis during intensive phase of chemotherapy in children with Acute lymphoblastic leukaemia. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/095772
Enrollment
118
Registered
2025-10-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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]

Interventions

Intervention1: Antibiotic prophylaxis: Oral Levofloxacin Control Intervention1: Standard practice: Standard practice

Sponsors

Sonali Aggarwal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed cases of Acute lymphoblastic leukaemia (high risk/ intermediate risk) during induction of remission and consolidation phase of therapy.

Exclusion criteria

Exclusion criteria: Relapsed acute lymphoblastic leukemia, infant leukaemia, refusal to consent, infective focus or bacteria at the time of diagnosis, allergy to quinolones.

Design outcomes

Primary

MeasureTime frame
Primary outcomes 1. Incidence of febrile neutropenia in both the groups. 2. Incidence of bacteria/microbiologically documented infections (MDI) in both the groups. Timepoint: From start of Induction of remission to end of consolidation therapy—

Secondary

MeasureTime frame
Secondary outcomes A. Assessment of the severity of febrile neutropenia between the groups. 1. Need for hospital admission 2. Need for Pediatric Intensive care unit admission. 3. Incidence of clinical complications. 4. Duration of hospitalization. 5. Mortality B. Risk associated with antibiotic prophylaxis. 1. Incidence of multi drug resistant organisms. 2. Incidence of invasive fungal infections. 3. Incidence of Clostridium difficle diarrhoea.Timepoint: From start of Induction of remission to end of consolidation therapy—

Countries

India

Contacts

Public ContactSonali Aggarwal

Post Graduate Institute of Medical Education and Research, Chandigarh

trehanamita@hotmail.com9815228866

Outcome results

None listed

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