Ceftobiprol in hospital-acquired pneumonia

Not Applicable

• Conditions: -J189 Pneumonia, unspecified-J958 Other postprocedural respiratory disorders; Pneumonia, unspecified; Other postprocedural respiratory disorders; J189; J958

• Registration Number: PER-074-05
• Lead Sponsor: JHONSON & JHONSON PHARMACEUTICALS,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-16
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1) Informed consent granted in writing. The consent of patients in a state of unconsciousness / incapacity may be granted by their direct relatives, guardians or legal representatives.
2) Subjects men and women ≥ 18 years of age.
3) Before beginning and throughout the entire study, women should be postmenopausal, surgically sterile or be practicing some effective method of birth control and the pregnancy test should be negative.
4) Subjects suffering from NP or VAP.
5) Microbiological samples suitable for culture and microscopy.
6) APACHE II score ≥ 8 and ≤ 25.

Exclusion Criteria

1. Subjects women who are pregnant or breastfeeding.
2. Known or suspected hypersensitivity to any medication of the
study.
3. Any known or suspected concurrent treatment or treatment contraindicated by the prescription information of linezolid or ceftazidime.
4. Severe deterioration of renal function.
5. Known or suspected hepatic dysfunction.
6. Baseline QTcB (Bazett correction)> 450 msec.
7. Previous enrollment in this study.
8. Treatment with any investigational medication within 30 days prior to enrollment.
9. Any other known or suspected disease of the subject, which could jeopardize compliance with the requirements of the protocol.
10. Known HlV-positive with count of ≤ 200 cells / mm3.
11. Presence of myelosuppression or neutropenia, severe anemia.
12. Children or other family members of the researcher or employees of the study center.
13. Sustained shock.
14. Subjects with: a) Confirmed bronchial obstruction or a history of postobstructive pneumonia, primary lung cancer or other metastatic malignancy of the lungs. b) Cystic fibrosis. c) Lung abscess. c) Pleural effusion as a source of primary infection. e) Active tuberculosis. f) Subjects that require antibiotic coverage due to aspiration pneumonia, atypical pneumonia or Pneumocystis jiroveci pneumonia.
15) Systemic antimicrobial therapy for more than 24 hours within 7 days prior to enrollment.
16) Evidence in available control cultures of coinfection with pathogens such as: Producers of ESBL, Proteus vuigaris and non-fermentors resistant to ceftazidime or ceftobiprole.

Study & Design

• Study Type: Interventional
• Study Design: Not specified