None listed
Conditions
Interventions
Group 1 Type of group
MK-0826 IV 1g / day will be applied for 10 to 14 days, with the option to raise the dose to two grams.
Group name:Group 2 Type of group
Ceftriaxone IV 1g / day will be applied for 10 to 14 days with option to raise the dose to 2g
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • Patient has a clinically suspected and/or bacteriologically documented community-acquired pneumonia, according to the following diagnostic criteria: • Clinical Criteria o New onset of a clinical picture compatible with bacterial pneumonia with at least TWO of the following signs and symptoms: o Cough; o Production of purulent sputum or an increase or a change in the character of sputum. For definitions of adequate sputum gram stain findings o Auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (dullness on percussion, diminished breath sounds, bronchial breath sounds, rales, rhonchi, wheezing, or egophony); o Dyspnea, tachypnea, hypoxemia. Pleuritic chest pain, particularly if any or all of these are progressive in nature; o Organism consistent with a respiratory pathogen isolated from blood culture; AND at least ONE of the following: o Fever, defined as body temperature >38°C (100.4°F) orally, >38.5°C o (101.2°F) tympanically, or>39°C (I02.2°F) rectally; o Chills; o An elevated total peripheral WBC >I0,000/mm3, or >15% immature neutrophils (bands), regardless of total peripheral WBC, or leukopenia with total WBC 25 polymorphonuclear (PMN) cells and o 18 Years (Males and females are Eligible) • Females of childbearing potential with a negative urine pregnancy test are eligible for enrollment; however, they must have a confirmatory negative serum pregnancy test (p-HCG). Use of adequate birth control measures should be discussed with the investigator. Hormonal contraceptives should not be used as the sole method of birth control because the effect of MK-0826 on the efficacy of hormonal contraceptives has n
Exclusion criteria
Exclusion criteria: • Failure to meet all inclusion criteria. • History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any adverse reaction to carbapenem antibiotics (such as imipenem), ceftriaxone sodium or any cephalosporins or penicillins. Patients with a history of mild (nonurticarial) rash to penicillins or other P-lactams may be enrolled. • History of allergy, hypersensitivity, intolerance, or any other adverse reaction to injectable multivitamin or any of its components. • Pregnant women, nursing women, or fertile women not practicing adequate methods of contraception in the judgment of the investigator; women who plan on becoming pregnant within 1 month of the study. • 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. • Sepsis syndrome with acute hemodynamic instability (such as requirement of pressors to maintain SEP >90 mm Hg) or adult respiratory distress syndrome should be excluded. Volume repletion (but not pressors) for support of blood pressure and the need for mechanical ventilation for patients with severe pneumonia is allowed. • Signs of meningitis, such as nuchal rigidity, papiliedema. or other findings of meningitis. Penetration of MK-0826 into the CSF has not yet been determined. • Patients who are hospitalized or in other long-term care facilities (such as nursing homes) for 48 hours or more before onset of pneumonia (hospital • acquired pneumonia), or patients hospitalized in the 2 week period prior to study entry. • Patients who are on mechanical ventilation prior to onset of pneumonia (ventilator-associated pneumonia). • Empyema, defined as pleural fluid that is frank pus with or without microorganisms in an exudate pleural fluid or pleural fluid with all of the following characteristics: • pH 3 times upper limit of normal (ULN) for serum • Glucose 1.5 times the upper limit of the range of normal values used by the laboratory performing the test (ULN). Patients who are on anticoagulant therapy with values >1.5 times ULN may be enrolled, provided these values are stable and within the therapeutic range. • Patients requiring peritoneal dialysis or hemodialysis, or hemofiltration should be excluded. • For patients wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:A detailed description and evaluation of the infectious process to include vital signs and signs and symptoms of pneumonia will be assessed prior to and throughout the study. The test of cure will be assessed at the early follow-up visit (7 to 14 days post treatment). Favorable clinical response includes cure. Overall microbiological response will also be assessed as favorable or unfavorable for each patient. Favorable microbiological responses include eradication and presumptive eradication. Measure:Efficacy Timepoints:14 days after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:A physical examination will be performed prestudy at Days 3, 4, or 5 on therapy, at the discontinuation of parenteral therapy, and at the early (7 to 14 days posttherapy) and the late (21 to 28 days posttherapy) follow-up visits. The patients will be monitored for clinical adverse reactions daily throughout study treatment up to and including 14 days postantibiotic therapy. Laboratory tests of blood and uriñe will be performed prestudy; on Days 3, 4. or 5 of antibiotic therapy, every 4 to 5 days thereafter during study antibiolic treatment, at the discontinuation of parenteral therapy, at early follow-up, and as necessary. Measure:Safety Timepoints:During administration of treatment, days 3, 4 and 5 | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed