A PROSPECTIVE, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, COMPARATIVE STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF MK-0826 VERSUS CEFEPIME IN THE TREATMENT OFHOSPITAL-ACQUIRED PNEUMONIA IN ADULTS
- Conditions
- -J159 Bacterial pneumonia, unspecifiedBacterial pneumonia, unspecifiedJ159
- Registration Number
- PER-030-99
- Lead Sponsor
- MERCK SHARP & DOHME PERÚ S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
A.Clinical and Radiographic Findings
The patient has a clinical picture of a new onset of hospital-acquired bacterial pneumonia >48 hours after hospitalization or admission to another skilled-care facility or onset within 3 days of discharge from either type of facility. In addition, at least two of the following should be present:
1.Cough, new or worsened,
2.New onset of the production of purulent sputum or other respiratory secretions or a change in the character of sputum for microbiological criteria definitions of adequate sputum Gram stain findings
3.Auscultatory findings on chest examination of rales and/or signs of pulmonary consolidation
4.Dyspnea, tachypnea (respiratory rate >20/minute), or pleuritic chest pain, particularly if any or all of these are progressive in nature,
5.Hypoxemia (e.g., PO2 <60 mm Hg or Sa02 <90%), while the patient is breathing room air.
In addition, at least one of the following clinical findings should be met:
1.Fever, OR hypothermia,
2.An elevated total peripheral white blood cell count (WBC >10,000/uL),>15% immature neutrophils (bands) regardless of total peripheral white count, or leukopenia with a total WBC <4500/uL (if caused by the infection).
B.Microbiologic Criteria:
1.At enrollment all patients should have a respiratory secretion specimen collected and sent to the laboratory for Gram´s stain and culture.
2.Microscopic examination of Gram-stained respiratory secretions (10 to 20 oil fields) should show <10 squamous epithelial cells and >25 polymorphonuclear cells per field at 100X magnification.
3.Two sets of blood cultures (both aerobic and anaerobic) from 2 different sites in all patients should be obtained prior to initiation of study drug.
4.Antimicrobial susceptibility testing should be performed on all pathogens isolated from respiratory tract infections.
C.≥18 Years (Males and Females are Eligible)
D.Females of childbearing potential must have a negative serum pregnancy test (B-HCG) prior to enrollment into the study. They must subsequently use adequate birth control measures for 1 month after the completion of study therapy as discussed with the investigator.
E.Patient´s infection is known or thought to be, in the opinion of the investigator, caused by microorganisms susceptible to the intravenous study antibiotics.
F.Patient´s infection has been treated with <24 hours of systemic antibiotic therapy.
G.If there is any suspicion of an outbreak of nosocomial Legionella infection at the study site, then a urine test for Legionella antigen must be performed and have negative results. If the results are not available until after enrollment, then patients with a positive Legionella antigen test may need to be withdrawn from study therapy.
A.Pneumonia acquired in an intensive care unit.
B.Pneumonia acquired while the patient is on mechanical ventilation.
C.Any patient who has received:
1.Broad-spectrum antibiotic therapy (effective against gram-negative and gram-positive bacteria) for >5 days in the 10 days prior to onset of pneumonia.
2.>24 hours of any systemic antibiotic therapy effective for the treatment of pneumonia in the last 72 hours unless the patient is a failure of the prior regimen.
D.Patients who are likely to require ventilator support for their pneumonia within 24 hours of onset.
E.Patients from whom Pseudomonas is isolated in an adequate prestudy sputum specimen.
F.History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any adverse reaction to carbapenem antibiotics (such as imipenem), cefepime, or any penicillins, p-lactams, cephalosporins, or metronidazole. Patients with a history of mild (nonurticarial) rash to penicillins or other p-lactams may be enrolled.
G.Pregnant women, nursing women, or fertile women who are not, in the judgment of the investigator.
H.Patients with a rapidly progressive or terminal illness, patients in whom a response to antibiotic therapy is considered unlikely, or patients who are considered unlikely to survive the study period.
I.Patients with empyema.
J.The need for concomitant systemic antibacterial agents in addition to the study antibiotics.
K.Concurrent infection that would interfere with evaluation of response to the study antibiotic.
L.Patients who are malnourished.
M.Patients with cystic fibrosis, bronchiectasis, AIDS, known or suspected Pneumocystis carínii pneumonia, known or suspected active tuberculosis, or who are on therapy for tuberculosis.
N.Patients with known bronchial obstruction or a history of postobstructive pneumonia. (Patients with chronic obstructive pulmonary disease [COPD] are eligible).
O.Patients with primary lung cancer or another malignancy metastatic to the lungs.
P.Patients who are receiving immunosuppressive therapy including the use of corticosteroids (>10 mg prednisone daily or equivalent) as chronic therapy.
Q.Hematocrit <25%; or Hemoglobin <8 g/dL (<80 g/L IU).
R.Neutropenia with absolute neutrophil count (ANC) <1000 cells/uL. Patients with ANCs as low as 500 cells/uL may be permitted if this reduction is due to the acute infectious process.
S.Platelet count <75,000/uL; patients with platelet counts as low as 50,000/uL will be permitted if this reduction is historically stable.
T.Patients requiring peritoneal dialysis, hemodialysis, or hemofiltration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method