INEZOLID IV / ORAL VS VANCOMYCIN IV IN THE TREATMENT OF RESISTANT GRAM POSITIVE BACTERIAL INFECTIONS IN CHILDRE
- Conditions
- -A49 Bacterial infection of unspecified siteBacterial infection of unspecified siteA49
- Registration Number
- PER-015-01
- Lead Sponsor
- PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Male or female patients, with age from birth to 11 years, including term and preterm infants. (Neonates [0 to 90 days] can begin their entry into the study, after the information in the pharmacokinetic protocol M / 1260/0064 has been analyzed separately.)
• At the time of recruitment, patients must have an expectation of survival with effective antibiotic therapy and adequate support of medical care during every study.
• Patients must be willing to complete all activities related to the study. The patient´s parent / guardian will provide informed consent and will take the patient to the required visits, answer questions related to adverse events and must comply with the administration of the study medication.
• Patients must present infection produced by resistant gram-positive bacteria, suspected or confirmed by laboratory findings (such as culture results and gram staining) or clinical signs and symptoms of an active infection, as defined in the following syndromes clinical Patients with mixed infections due to gram-positive pathogens who also have gram-negative bacteria may enter the study.
• Patients must require a minimum of 3 days with IV treatment.
• More than 24 hours of treatment with a potentially effective antibiotic, in the last 48 hours before your first injection, until the first treatment has failed (defined as absence of clinical improvement after 3 days of treatment) or that the pathogen show resistance to the assigned study drug. Patients with documented ERV will be allowed in the study and those assigned to treatment with vancomycin will be switched to treatment with linezolid.
• Infection (s) in which they can be expected to be cured only with surgical incision (eg, isolated furunculosis or single abscess).
• Medical conditions in which inflammation is prominent for a long period, even after successful bacterial eradication (eg, superinfected eczema or atopic dermatitis).
• Pre-existing pulmonary conditions not known or suspected (such as tuberculosis or kidnappings), which may prevent the evaluation of the therapeutic response.
• Infection (s) that require concomitant, potentially effective systemic therapy.
• Decubitus or ischemic ulcers (unless associated with cellulitis), necrotizing fasciitis, gas gangrene or burns greater than 20% of the total body surface area.
• Patients under 5 years of age who have a highly suspicious diagnosis of H influenzae Type B, without a record of vaccination against H influenzae type B, or those who are partially immunized (vaccination not updated according to their age).
• Infections due to gram-positive pathogens with known resistance to the drugs under study, except when ERV has been identified.
• Patients with infected devices, due to species of S aureus and Enterococcus, which will not be removed.
• Patients with pneumonia or bacteremia due to S pneumoniae sensitive to penicillin (MIC <2ug / ml).
• Endocarditis, musculoskeletal infections (including osteomyelitis / septic arthritis) and CNS infections.
• Knowledge that the patient has pheochromocytoma, carcinoid syndrome, untreated hyperthyroidism or uncontrolled hypertension.
• Hypersensitivity to linezolid or vancomycin or to any of the excipients of any of the formulations of the drugs under study.
• Previous admission in this protocol or another protocol in which linezolid was used concomitantly.
• Concomitant use of other drugs in the research phase, not approved.
• Female patients who have reached menarche.
• Patients with phenylketonuria, who have the possibility of receiving Linezolid Microcap suspension.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Clinical Response Evaluation, Clinical History, Physical Examination, Clinical Observations, Vital Signs<br>Measure:Clinical Evolution of the Patient<br>Timepoints:Clinical history, physical examination at the baseline visit<br>Evaluation of the Clinical Response 72 hours after the end of the treatment<br>Clinical Observations and Vital Signs on Days 3, 10, 17 and 24<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Measurement of the size of the lesion (length, thickness, area)<br>Measure:Size of the Lesions<br>Timepoints:From the basal registry to the follow-up<br>;<br>Outcome name:Physical Examination, Clinical Observations, Vital Signs<br>Measure:Evolution of clinical signs and symptoms<br>Timepoints:On all of the visits<br>;<br>Outcome name:Infection site culture and gram stain, Blood culture<br>Measure:Individual rates of pathogen eradication<br>Timepoints:Basal and 12-28 days after the last<br>dose<br>;<br>Outcome name:Oral temperature, Hemogram<br>Measure:Body Temperature and the white blood cell count<br>Timepoints:On each evaluation visit<br>;<br>Outcome name:Registry of adverse events<br>Measure:Safety<br>Timepoints:When the event happens<br>