Blood or hematopoietic organ diseases
Conditions
Interventions
Experimental Group:contezolid
Sponsors
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1.Pneumonia or complicated skin and soft tissue infections (cSSTI) caused by known or suspected Gram-positive bacteria. 2.Inpatients aged 2 to 17 years who require or have already undergone hematopoietic stem cell transplantation. 3.Capable of swallowing or receiving medication through a nasogastric tube or other feeding devices. 4.Able to comply with the study procedures and complete follow-up. 5.Individuals who have signed the informed consent form (for subjects aged >=8 years, both the subject and the guardian must sign the informed consent form; for subjects aged <8 years, the guardian must sign the informed consent form).
Exclusion criteria
Exclusion criteria: 1. Pediatric patients with abnormal intestinal function expected to significantly affect drug absorption; 2. Patients who must use vasoactive drugs for septic shock; 3. Patients who need invasive mechanical ventilation therapy; 4. Those with pSOFA score >=2; 5. Phoenix Sepsis Score total score >=2 points; 6. Has or is suspected to have a history of severe renal impairment (e.g., CrCl 2 times, or alanine aminotransferase [ALT] or aspartate transfection Ammonia [AST]>=5 times the upper limit of normal [ULN]); 8. Allergy to oxazolidinones; 9. Any condition that, in the opinion of the investigator, may jeopardize patient safety or affect the evaluation of efficacy 10. Within 1 month prior to enrollment, received interventional clinical studies of other drugs or medical devices; 11. Subjects who have been treated with systemic effective antibiotics for more than 48 hours within 96 hours prior to enrollment, unless documented as treatment failure (96 hours of treatment with no response); 12. Disease-specific exclusion criteria Disease-specific exclusion criteria: (1) Pneumonia: patients with any of the following lung diseases: aspiration pneumonia, suspected simple viral, fungal or atypical pathogen pneumonia, known bronchial obstruction or history of obstructive pneumonia, known structural lung disease (such as bronchiectasis, cystic pulmonary fibrosis), primary or metastatic lung malignancy, known or suspected active pulmonary tuberculosis, Pneumocystis pneumonia, lung abscess, and patients with neurological diseases that affect normal secretion clearance; (2) Complex skin and soft tissue infections (cSSTIs) can be cured by surgical incision alone without the need for systemic antibiotics; Inflammatory skin conditions (eczema or atopic dermatitis superinfection) that may affect their response to treatment, pressure ulcers, necrotizing fasciitis, progressive gangrene, infection after a human or animal (other than arthropod) bite, people with an artificial device that cannot be removed from the site of infection, patients with confirmed or suspected osteomyelitis, patients with confirmed or suspected septic arthritis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of drug-related adverse events in the safety population; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in hematological parameters in the safety population;Incidence of hematologic adverse events in the safety population;Microbiological eradication rate;Incidence of organ-related adverse events in the safety population;Clinical efficacy rate;Clinical efficacy rate by disease category; | — |
Countries
China
Contacts
Public ContactXiaodong Wang
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed