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efficacy of prophylactic Levofloxacin for prevention of gut infection among de-novo AML patients: a randomised study

the impact of prophylactic Levofloxacin on gut microbiota of de-novo AML patients: a randomised study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17011239
Enrollment
Unknown
Registered
2017-04-25
Start date
2017-05-01
Completion date
Unknown
Last updated
2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia

Interventions

study group:prophylactic Levofloxacin
control group:no prophylactic antibiotics

Sponsors

Rui Jin hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai Institute of Hematology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. AML patients; 2. To be aged 18-60 years; 3. hepatic and renal function: Total bilirubine=35umol/L,AST/ALT less than 2 times of normal upper limit,creatinine<=150umol/L; 4. Normal cardiac function NYHA I/II; 5.Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2; 6. no former chemotherapy before induction; 7. Non-pregnant and non-nursing; 8. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test to rule out pregnancy; 9. written informed consent signed.

Exclusion criteria

Exclusion criteria: 1. Previous MDS history, treatment related AML; 2. Previously treated patients; 3. Allergy to any medication in the regimen; 4. Liver and renal insufficiency (beyond the inclusion criteria); 5. Patients with ejection fraction 2); 6. Patients with a "currently active" second malignancy; 7. Patients with "currently active" tuberculosis. Patients with HIV;active HBV, HCV, or Hepatitis A infection; 8. Patients with other hematological disease (including disturbance of blood coagulation not caused by AML); 9. Patients who can't understand or obey the protocol; 10. patient obtained chemotherapy and/or antibiotics during the latest three months; 11. patients with evidence of infection at the time of admission; 12. Other circumstance that obstructs the clinical trial.

Design outcomes

Primary

MeasureTime frame
event free survival;

Secondary

MeasureTime frame
febrile duration;gut microbiome diversity;

Countries

China

Contacts

Public ContactJunmin Li

Rui Jin hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai Institute of Hematology

lijunmin@medmail.com.cn+86 021-64370045-665258

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026