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Search / Trial NCT04270786

Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever

Launched by SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Feb 13, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Neutropenic Fever, Empiric, Antibiotics

ClinConnect Summary

This clinical trial is studying a new approach to treating patients with neutropenic fever, which is a serious condition often seen in people undergoing hematopoietic stem cell transplantation (HSCT). The trial aims to find out if it is safe and effective to stop strong antibiotics early when patients have been fever-free for 72 hours, compared to continuing the antibiotics for a longer period. Participants will be randomly assigned to one of two groups: one group will stop the antibiotics and switch to a preventive medication called levofloxacin, while the other group will keep receiving the antibiotics for at least a week or until their blood cell levels improve.

To be eligible for this trial, participants must be at least 18 years old, have experienced neutropenic fever, and have been fever-free for at least 72 hours. However, those with certain infections or severe conditions, like septic shock, cannot participate. The trial is currently recruiting participants, and everyone involved will need to give their consent to join. This study is important because it may help improve the care and treatment of patients with neutropenic fever, potentially leading to shorter antibiotic use and reduced side effects.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age ≥18,patients undergo hematopoietic stem cells
  • Patients with neutropenic fever: T≥38.5°C once or T≥38°C twice a day with ANC \<0.5x109/L or predicted to be \<0.5x109/L in 24 \~48 hours;
  • Patients achieved afebrile (T\<37.5°C)for at least 72 hours;
  • Inform consent given
  • Exclusion Criteria:
  • Patients with neutropenic fever with documented blood stream infection, skin and soft tissue infection, pneumonia and catheter associated infection.
  • Patients with septic shock
  • Levofloaxin allergy or contra-indication

About Shanghai Jiao Tong University School Of Medicine

Shanghai Jiao Tong University School of Medicine is a leading academic institution in China, renowned for its commitment to advancing medical research and education. As a prominent clinical trial sponsor, the school leverages its extensive expertise in biomedical sciences and innovative healthcare solutions to conduct rigorous clinical studies aimed at improving patient outcomes. With a focus on collaboration and translational research, the institution fosters partnerships with healthcare providers, industry leaders, and regulatory bodies to ensure the highest standards of scientific integrity and ethical conduct in clinical trials. Through its research initiatives, Shanghai Jiao Tong University School of Medicine strives to contribute significantly to the global medical community and enhance the quality of healthcare delivery.

Locations

Shanghai, , China

Shanghai, Shanghai, China

Patients applied

0 patients applied

Trial Officials

Jiong hu

Principal Investigator

Ruijin Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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