To study the effect of using antibiotics prophylactically (levofloxacin) in children with acute leukemia to prevent the occurrence of fever due to fall in neutrophil count.
Not Applicable
- Conditions
- Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]Health Condition 2: C920- Acute myeloblastic leukemia
- Registration Number
- CTRI/2023/06/053942
- Lead Sponsor
- It is a institute based PG thesis protocol
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Children age between 1 to 14 years receiving intensive chemotherapy for acute leukemia.
2.Written informed consent.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br>2. at the end of 3 months.
- Secondary Outcome Measures
Name Time Method 1. Incidence of mortality during the episodes of febrile neutropenia in both the interventional placebo group <br/ ><br>2. Need for hospitalisation in both the groups <br/ ><br>3.Blood culture sensitivity patterns in both the groups during episodes of febrile neutropenia. <br/ ><br>4.Time to first febrile neutropenia episode. <br/ ><br>5. Side effect profile in both the groupsTimepoint: 1. whenever the child develops fever during 3 months <br/ ><br>2. whenever the child develops any side effects during 3 months <br/ ><br>3. at the end of 3 months