Health Condition 1: C920- Acute myeloblastic leukemia Health Condition 2: C910- Acute lymphoblastic leukemia [ALL] Health Condition 3: C859- Non-Hodgkin lymphoma, unspecified Health Condition 4: C950- Acute leukemia of unspecified celltype
Conditions
Interventions
Intervention1: Arm A Personalized Antibiotic Group (De-escalation Policy): Children in this group will get antibiotics based on their rectal swab test results when they develop a fever during chemot
Sponsors
Tata Memorial Centre Research Administration Council TMCTRAC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children less than 15 years of age 2. Diagnosed with a hematolymphoid neoplasm including Acute lymphoblastic leukemia IR and HR B-ALL or T ALL, Acute Myeloid leukemia, MPAL, Non-Hodgkins lymphoma 3. Induction phase of therapy 4. Adequate renal function is defined as a serum creatinine based on age or gender as follows: Age Maximum serum creatinine mg per dL Male Female 1 to 2 years 0.6 0.6 2 to 6 years 0.8 0.8 6 to 10 years 1 1 10 to 13 years 1.2 1.2 13 to 16 years 1.5 1.4 less than 16 year 1.7 1.4 5. Adequate liver function is defined as a. Total direct bilirubin less than 1.5 times upper limit of normal for age b. AST and ALT less than 2.5 times upper limit of normal for age
Exclusion criteria
Exclusion criteria: 1.Children diagnosed with Hodgkin lymphoma and Nodular lymphocyte predominant Hodgkin lymphoma (NLPHL) or Langerhans cell histiocytosis(LCH) or APL or SR- BCP ALL or Relapsed refractory leukemia or lymphoma. 2. Those with a history of MDR sepsis within 30 days before presentation 3. Any other phase of therapy (other than induction) 4. Those who do not consent or assent to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A. Primary outcomes 1. To find out if there is a difference in the mortality rate between the two groups of children during the early phase of their cancer treatment.Timepoint: Start: When the child is enrolled in the study (about 1 week after diagnosis) End: When the first phase of chemotherapy (induction) is completed usually 4 to 5 weeks later Monitored During: Any serious infection or health worsening End of the induction phase to check recovery status | — |
Secondary
| Measure | Time frame |
|---|---|
| B. Secondary outcomes Estimate how often multi-drug resistant infections (bacteremia) occur in the study groups. Compare how long children stay in the hospital due to infections between the two groups. Compare how many children in each group need to be admitted to the Intensive Care Unit (ICU). Check if the bacteria found in rectal swabs match those found in blood, urine, or respiratory cultures, and compare their antibiotic sensitivity. Timepoint: How often drug-resistant blood infections happen When we start counting: As soon as the child joins the study (around diagnosis) When we stop counting: By the end of the first chemotherapy phase (about 4 5 weeks later) Length of hospital stay because of infection When we start counting: From the moment the child develops a fever with low immunity or is diagnosed with sepsis When we stop counting: When the child goes home or the first treatment phase ends How many children need ICU care When we start counting: From the moment they develop a fever with low immunity or sepsis When we stop counting: When they no longer need ICU care or when the first treatment phase ends Whether the germs in the rectal swab match those in blood/urine/respiratory tests When we start comparing: At the initial rectal swab (within a week of diagnosis) When we finish comparing: When any blood, urine, or breathing-related tests are done later if an infection occurs;C. Exploratory Outcome Find out exactly which resistance genes the bacteria from the rectal swab carry.Timepoint: When we start: As soon as we take the first rectal swab (within a week after the child is diagnosed) When we finish: When the lab finishes testing which antibiotics the bacteria respond to and checks the bacteria s genes | — |
Countries
India
Contacts
Public ContactDr Chetan Dhamne
Tata Memorial Centre
Outcome results
None listed