None listed
Conditions
Interventions
tigeglycine Type of group
Endovenous tigeglycine is administered for 7 to 14 days.
Group name:IMIPENEM / CILASTATIN Type of group
IMIPENEM / CILASTATIN intravenous is administered for 7 to 14 days.
Sponsors
LABORATORIOS WYETH S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: Female or male patients 18 years of age or older. Patients with diagnosed or suspected acute intrahospital pneumonia. The presence of a new infiltrate or an evolving infiltrate, as can be seen on chest x-rays or computed tomographies performed> 48 hours after the patient has been admitted to the hospital.
Exclusion criteria
Exclusion criteria: Presence of any of the following pulmonary conditions: fibrosis cystic, lung cancer (primary or metastatic), diagnostic bronchial obstruction or post-obstructive pneumonia, lung abscess, etc. Known or suspected Legionella infection. Hemodialysis, peritoneal dialysis, plasmapheresis or hemoperfusion concurrent. Treatment-concomitant with ganciclovir. Score on the APACHE II scale> 30.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The vital signs will be monitored daily while the subject is receiving the test article, in the early follow-up and in the evaluation of the OCD. Laboratory evaluations will be carried out as indicated in the study flow chart. Clinical and microbiological efficacy will be evaluated. Measure:To compare the efficacy and safety of the regimen with tigecycline against imipenem / cilastatin in subjects with nosocomial pneumonia. Timepoints:14 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:A microbiological response will be assigned at the subject level: eradication, persistence, superinfection, or indeterminate. Measure:To evaluate the microbiological efficacy of tigecycline. Timepoints:day 14 | — |
Countries
Peru
Outcome results
None listed