Tigecycline in the empiric therapy of fever in high-risk granulocytopenic haematologic cancer patients

Not Applicable

Completed

Conditions: Febrile neutropenia/bacterial infections in immunocompromised cancer patients
Cancer

Registration Number: ISRCTN00586497

Lead Sponsor: niversity of Perugia (Italy)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 390

Inclusion Criteria

1. Consecutive adult (>18 age)
2. Cancer patients were eligible for randomization if they had fever ((=38.5°C on one occasion or =38°C on two or more occasions within 12 hours)
3. Chemotherapy-induced neutropenia (absolute neutrophils count less than 1000 per cubic millimeter anticipated to decrease to fewer than 500 cells per cubic millimeter within 24 to 48 hours) and a presumed infection
4. Patients were enrolled only once in the study and were hospitalized at the participating centres

Exclusion Criteria

1. Had received any intravenous antibiotics during the preceding 96 hours
2. Had a known allergy to any of the protocol antibiotics
3. Had renal failure requiring hemo- or peritoneal dialysis or a serum creatinine level greater than 25 ml/min
4. Were pregnant or had known human immunodeficiency virus infection

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The success rates of the antibiotic regimens. We considered the response a ?success? if fever and clinical signs of infection resolved and if the infecting microorganisms were eradicated without change of the initial allocated treatment. Response was defined as a ?failure? if the patient died as a result of primary infection; if bacteremia persisted beyond the first 24 hours of therapy; if a breakthrough bacteremia was documented; if the isolated pathogen was resistant to the assigned antibiotics; if no response was seen after at least 72 hours of empiric therapy; if shock or acute respiratory distress syndrome or a disseminated intravascular coagulation or multiple organ failure was observed; if infection relapsed within 7 days of discontinuation of treatment; and if toxicity occurred that required interruption of treatment.<br>Response was also evaluated by assessing survival at day 30.

Secondary Outcome Measures