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| Name | Class |
|---|---|
| Asociacion Colombiana de Infectologia, ACIN. Infectious Diseases Society of Colombia | UNKNOWN |
| Hospital Simon Bolivar, Bogota | UNKNOWN |
| Clinica Palermo, Bogota | UNKNOWN |
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To determine the efficacy of the administration of 7 to 14 days of cefepime in a continuous infusion vs an intermittent (every 8 hours) administration, in adult patients hospitalized in Bogotá with sepsis and bacteremia caused by gram negative bacilli. The outcome was the rate of clinical cure and microbiological cure after 7 and 14 days of initiation of therapy and rates of relapse after 28 days.
Hypothesis: The administration of beta lactams in continuous infusion allows a clinical or microbiological cure greater than the intermittent administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | Administration of cefepime in continuous infusion (3 Gr over 24 hours) for at least 7 days and no more than 14 days days at the discretion of the investigator. Administration of saline solution 0.9%, 50-100 mL over 30 minutes every 8 hours. |
|
| II | Active Comparator | Administration of cefepime in intermittent infusion (1 Gr over 30 minutes every 8 hours) for at least 7 days and no more than 14 days days at the discretion of the investigator.Administration of saline solution 0.9%, 50-250 mL over 24 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cefepime | Drug | Administration of cefepime in continuous infusion (3 Gr over 24 hours) for 7-14 days at the discretion of the investigator. Administration of saline solution 0.9%, 50-100 mL over 30 minutes every 8 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate global mortality rate | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| to evaluate clinical and/or microbiologic relapses | 28 days | |
| To evaluate clinical and bacteriological response | 3 days | |
| to evaluate clinical and bacteriological response |
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Inclusion Criteria:
Exclusion Criteria:
Patients with a high degree of immunosuppression defined by:
Patients with chronic renal failure.
Pregnant female patients
Patients in whom to approach the doctor is considered with a high probability of dying in the next 48 hours (e.g. multiorgan system failure with more than 5 organs engaged according to the criteria of MarshalL et al. or shock irreversible.
Patients with chronic infections as osteomyelitis or have prosthesis that would perpetuate the infection and requiring the administration of antibiotics for an extended time (including Endocarditis). -Patients with mixed infections that include Gram positive microorganisms or fungal infections.
-Patients who have received in the past 30 days cefepime.
Patients with presence of a gram negative bacillus resistant to cefepime. -Patients who are not able to identify them a bacillus gram negative.
Patients who they are not able to confirm the antibiotic susceptibility of gram negative bacillus. -Patients with concomitant with antimicrobial activity for Gram negative bacilli (e.g. fluoroquinolones, aminoglycosides, etc.)
Patients who have known hypersensitivity to B lactams or cefepime
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| Name | Affiliation | Role |
|---|---|---|
| carlos A Alvarez, MD | Pontificia Universidad Javeriana | Principal Investigator |
| Alvaro Ruiz, MD; MSc | Pontificia Universidad Javeriana | Study Chair |
| Fabian GIL, Msc | Pontificia Universidad Javeriana | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital San Juan de Dios | Rionegro | Antioquia | Colombia | |||
| Clinica Palermo |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D016470 | Bacteremia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077723 | Cefepime |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Hospital Santa Clara, Bogota |
| UNKNOWN |
| Fundación San Carlos, Bogota | UNKNOWN |
| Hospital san Juan de Dios, Antioquia | UNKNOWN |
| Hospital san Jorge, Pereira | UNKNOWN |
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|
| cefepime | Drug | Administration of cefepime in intermittent infusion (1 Gr over 30 minutes every 8 hours) for 7-14 days at the discretion of the investigator.Administration of saline solution 0.9%, 50-250 mL over 24 hours |
|
|
| 7 days |
| to evaluate clinical and bacteriological response | 14 days |
| Bogotá |
| DC |
| 6 |
| Colombia |
| Fundacion San Carlos | Bogotá | DC | 6 | Colombia |
| Hospital Santa Clara | Bogotá | DC | 6 | Colombia |
| Hospital Simon Bolivar | Bogotá | DC | 6 | Colombia |
| Hospital Universitario san Ignacio | Bogotá | DC | 6 | Colombia |
| Hospital San Jorge | Pareira | Risaralda Department | Colombia |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |