acute lymphocytic leukemia
Conditions
Interventions
Faropenem group:Faropenem (5mg/kg, three times daily) was used from day 3 of chemotherapy until the agranulocytosis was resolved
Levofloxacin group:Levofloxacin (8mg/kg, twice daily) was used from day 3 of chemotherapy until the agranulocytosis was resolved
Sponsors
The People’s Hospital of Guangxi Zhuang Autonomous Region
Eligibility
Sex/Gender
All
Age
8 Months to 19 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria of primary pediatric intermediate/high-risk ALL; 2. Aged from 8 months to 19 years old; 3. Intermediate/high risk ALL patients treated according to CCCG-ALL-2020 protocol or expansion protocol; 4. Chemotherapy stage: re-induction; Before chemotherapy, WBC > 2.0×10^9/L, ANC > 0.5×10^9/L, PLT > 50×10^9 /L, TBIL < 34µmol/L, DBIL < 24 µmol/L, ALT < 5 times the upper limit of normal; 5. Sign informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria: patients with any of the following conditions were excluded from the clinical study 1) trisomy 21 syndrome, or congenital or hereditary disease with damage to viscera function; 2) congenital immunodeficiency or metabolic diseases; 3) congenital heart disease with cardiac insufficiency; 4) presence of active infection; 5) Allergic to faropenem or levofloxacin; 6) patients with a history of allergy to penicillins, cephalosporins or carbapenems; 7) The children or their relatives are prone to allergic symptoms such as bronchial asthma, rash, urticaria, etc. 8) patients with chronic active arthritis; 9) patients with known pathologic QTc prolongation; 10) Patients receiving antimicrobial therapy, excluding any of the following: 1. Compound sulfamethoxazole tablets (SMZ) for Pneumocystis jirovecii (PCP) prophylaxis 2. Topical antibiotics 3. Antibiotic sealing of central venous catheter 4. Preventive fungal treatment (concomitant medication); 11) renal insufficiency; 12) any impact on patient safety, compliance, informed consent, study participation, follow-up, or result interpretation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of agranulocytosis with fever; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of infection;Hospitalization expense;Incidence of adverse drug reactions; | — |
Countries
China
Contacts
Public ContactDai Yan
The People’s Hospital of Guangxi Zhuang Autonomous Region
Outcome results
None listed