Health Condition 1: C00-D49- Neoplasms Health Condition 2: D50-D89- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
Conditions
Interventions
Intervention1: Continuous infusion: Group A (Continuous Infusion Group): Patients will receive meropenem at 60–120
mg/kg/day (up to a maximum of 3 g/day) as a 24-hour continuous infusion. The
durati
Sponsors
Dr M S Ganachari
Eligibility
Inclusion criteria
Inclusion criteria: 1. All paediatric patients aged below 18 years, diagnosed with any type of cancer. 2. Patients undergoing chemotherapy for both haematological malignancies and solid tumours. 3. Absolute neutrophil count (ANC) less than 500 cells per microlitre. 4. Patients who have a documented fever of more than or equal to 38.3°C (101°F) or more than or equal to 38°C (100.4°F) for more than one hour, unrelated to administration of blood products or pyrogenic substances. 5. Informed consent obtained from parents or guardians. 6. Prescribed meropenem administered either as a 24-hour continuous infusion or as a 2 hour intermittent infusion.
Exclusion criteria
Exclusion criteria: 1. Patients who refuse to provide informed consent by parent or legal guardian. 2. Prior or ongoing treatment with carbapenems or multiple broad-spectrum antibiotics before enrolment. 3. Known hypersensitivity or allergic reaction to meropenem or other carbapenem-class antibiotics. 4. Presence of severe renal or hepatic dysfunction, as determined by the treating physician. 5. Patients undergoing chemo-radiotherapy with bone marrow or peripheral stem cell transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome would be to monitor the duration of fever resolution and also the duration of neutropenia.Timepoint: Within 7 days of starting therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome would be to assess the duration of hospitalization & to evaluate the mortality & survival rates.Timepoint: During treatment period from day 0 to day 30;To record any adverse effects associated with the use of antibiotics & to track the development of any resistant bacterial strains in the study population.Timepoint: During treatment period till day 30 | — |
Countries
India
Contacts
Public ContactDr Ashwini Doddannavar
KLE Academy of Higher Education and Research Nehru Nagar Belagavi-590010
Outcome results
None listed