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A randomized controlled multicenter study of evaluating the efficacy and safety of initral empiric combination of linezolid in febrile neutropenia.

A randomized controlled multicenter study of evaluating the efficacy and safety of initral empiric combination of linezolid in febrile neutropenia.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16008828
Enrollment
Unknown
Registered
2016-07-12
Start date
2016-08-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

febrile neutropenia

Interventions

Exprimental group:imipenem-cilastatin combined with Linezolid
Control group:imipenem-cilastatin monotherapy

Sponsors

Shanghai General Hospital,Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years, both female and male; 2. ANC of 5×normal values) or renal insufficiency (defined as a creatinine clearance of <30 mL/min).

Exclusion criteria

Exclusion criteria: 1. patients who were pregnant or lactating; 2. Known allergy to drugs being prescribed; 3. Patients that can't guarantee complete the plan and follow up; 4. Intravenous antibiotics are being used when entering the group; 5. Indications for addition of antibiotics active against gram-positive organisms: 1) Hemodynamic instability or other evidence of severe sepsis; 2) Clinically suspected serious catheter-related infection (eg, chills or rigors with infusion through catheter and cellulitis around the catheter entry/exit site); 3) Skin or soft-tissue infection at any site; 4) Pneumonia documented radiographically.

Design outcomes

Primary

MeasureTime frame
defervescence time;clinical effective rate;bacterial clearance rate;

Countries

China

Contacts

Public ContactWang Chun

Shanghai General Hospital,Shanghai Jiao Tong University School of Medicine

persantin@163.com+86 21 63240090-3925

Outcome results

None listed

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