Health Condition 1: C910- Acute lymphoblastic leukemia [ALL] Health Condition 2: C920- Acute myeloblastic leukemia
Conditions
Interventions
Intervention1: Levofloxacin: Levofloxacin prophylaxis in Children age between 1 to 14 years receiving intensive chemotherapy for acute leukemia.
Control Intervention1: Other group: Receive standard of
Sponsors
It is a institute based PG thesis protocol
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children age between 1 to 14 years receiving intensive chemotherapy for acute leukemia. 2.Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Standard risk ALL 2. Patient on systemic antibiotics at the time of enrollment except septran prophylaxis 3.Known allergy to quinolones 4.Known case of arthritis 5.Relapse case of acute leukemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Determine the effect of levofloxacin prophylaxis in children receiving intensive chemotherapy for acute leukemia in reducing the incidence of febrile neutropenia episodes during the study period of two consecutive chemotherapy cycles, compared to placeboTimepoint: 1. When child develops fever during 3 months. 2. at the end of 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of mortality during the episodes of febrile neutropenia in both the interventional placebo group 2. Need for hospitalisation in both the groups 3.Blood culture sensitivity patterns in both the groups during episodes of febrile neutropenia. 4.Time to first febrile neutropenia episode. 5. Side effect profile in both the groupsTimepoint: 1. whenever the child develops fever during 3 months 2. whenever the child develops any side effects during 3 months 3. at the end of 3 months | — |
Countries
India
Contacts
Public ContactDr Lokesh M R
All India Institute Of Medical Sciences, New Delhi
Outcome results
None listed