INEZOLID (PNU 100766) ADMINISTERED BY INTRAVENOUS AND ORAL VIA FOR THE TREATMENT OF COMPASSIVE USE IN PATIENTS WITH BACTERIAL INFECTIONS WITH SIGNIFICANT RESISTANCE

Not Applicable

• Conditions: -A499 Bacterial infection, unspecified; Bacterial infection, unspecified; A499

• Registration Number: PER-052-00
• Lead Sponsor: PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-09-25
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Microbiological: A significant infection (non-colonization) caused by a susceptible organism. There must be a pathogenic organism identified in the area of ​​infection. Resistance or intermediate susceptibility of the organism to conventionally marketed antimicrobial agents, used to treat infections caused by said organism, clinical intolerance to them, or inability to tolerate long-term intravenous treatment.
• Signs and Symptoms: Patients admitted to this program will demonstrate / have demonstrated, signs of a significant infectious disease, such as fever, chills with shivering, leukocytosis with prominent change to the left, or significant changes in vital signs.
• Sex: Men and women are eligible to enter this study of the treatment program for compassionate use. Women of childbearing age should have a baseline pregnancy test, before taking linezolid, and practice an appropriate method for birth control, in order to avoid pregnancy while participating in this program. Since drug interaction studies with hormonal contraceptives were not conducted, the use of barrier or abstinence methods is recommended.
• Age: Patients must be 5 years or older. It should be noted that only a few observations were made with linezolid in patients under 18 years of age. For more information, please see the Linezolid Researcher´s Booklet.
• Clinical: Patients with pheochromocytoma, uncontrolled hyperthyroidism, or uncontrolled hypertension should consult the Medical Monitor of the Market Company for dosing.
• Origin of the Infection: If the origin of the infection is a device or a prosthesis, it is expected to be removed.

Exclusion Criteria

• Pregnancy: Pregnancy is a relative contraindication since the safety of linezolid in the human fetus is unknown. The sponsor and regulatory agencies will have to agree to admit any pregnant patient.
• Allergy: No patient will be admitted with sensitivity to oxazolidinones or to one of the excipients of any of the formulations

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical efficacy will be evaluated as the investigators evaluation of the overall clinical response:<br>• Cured: resolution of the signs and symptoms of the disease noted upon admission.<br>• Failure: persistence of the presence of signs or symptoms and / or new unfavorable findings, referring to the efficacy measurements, subsequent to entering the treatment program of compassionate use.<br>• Undetermined: mitigating circumstances that prevent classification in any of the previous categories, or symptoms in process of resolution but not complete.<br>Measure:Clinical Efficacy<br>Timepoints:In the follow-up visit<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical and laboratory evaluations designed to detect adverse events.<br>Measure:Safety<br>Timepoints:Throughout the treatment and the aftercare period,<br>