A Supponive, Prospective, Multicenter, Double-BIind, Randomized, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of MK-0826 Versus Ceftriaxone Sodium in the Treatment of Serious Community-Acquired Pneumonia in Adults
- Conditions
- J189Pneumonia, unspecified-J189 Pneumonia, unspecified
- Registration Number
- PER-001-00
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
•Patient has a clinically suspected and/or bacteriologically documented community-acquired pneumonia, according to the following diagnostic criteria:
•Clinical Criteria
oNew onset of a clinical picture compatible with bacterial pneumonia with at least TWO of the following signs and symptoms:
oCough;
oProduction of purulent sputum or an increase or a change in the character of sputum. For definitions of adequate sputum gram stain findings
oAuscultatory 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);
oDyspnea, tachypnea, hypoxemia. Pleuritic chest pain, particularly if any or all of these are progressive in nature;
oOrganism consistent with a respiratory pathogen isolated from blood culture;
AND at least ONE of the following:
oFever, 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;
oChills;
oAn elevated total peripheral WBC >I0,000/mm3, or >15% immature neutrophils (bands), regardless of total peripheral WBC, or leukopenia with total WBC <4,500/mm3.
oUnexplained hypothermia, defined as rectal core temperature of (96.8°F)
•Radiographic Criteria
oWithin 48 hours prior to and after the initiation of therapy, the chest radiograph should show the presence of a new or progressive infiltrate, consolidation, cavitation, or pleural effusion in order to establish the diagnosis. The state of hydration of the patient at the time of the initial radiograph should be taken into consideration. Repeat films taken after hydration or diuresis are acceptable. provided they are taken within the above time frame.
•Microbiological Criteria
oWithin 24 hours prior to the time of enrollment, all patients should have a sample of respiratory secretions obtained by any of the following means: deep expectoration. nasotracheal aspiration, intubation with endotracheal suctioning, bronchoscopy with bronchoalveolar lavage (BAL) or protected-brush sampling, transtracheal aspiration, percutaneous lung or pleural fluid aspiration.
oThe sample should be sent to the sites microbiology laboratory for the following tests: Gram stain, culture, and susceptibility testing.
oMicroscopic examination of the Gram-stained sputum should show presence of microorganisms, >25 polymorphonuclear (PMN) cells and
o<10 squamous epithelial cells/field at 100 times magnification (low-power, 10 times objective). Only appropriate specimens should be cultured. (For BAL specimens and respiratory secretions other than expectorated sputum, gram stain should show the presence of any PMNs.)
oBlood culture testing should be done for all patients. If blood culture results are known and a common respiratory pathogen is present, the patient is eligible for enrollment in the absence of positive sputum, regardless of age.
•Age >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
•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 <7.2
• LDH >3 times upper limit of normal (ULN) for serum
• Glucose <40 mg/dL
•Patients who have received appropriate antimicrobial therapy for 24 hours or more prior to enrollment. Unless there is a clear indication that the patient has failed this regimen as specified in the inclusion criteria.
•The need for concomitant systemic antimicrobials in addition to the study antibiotics.
•Concurrent infection that would interfere with evaluation of response to the study antibiotic.
•Patients with a prior history of tuberculosis and who: (1) are currently on therapy, or (2) have active untreated tuberculosis, or (3) have a positive acid fast bacili (AFB) smear.
•Hematocrit <25%; or hemoglobin <8 g/dL.
•Neutropenia with absolute neutrophil count (ANC)<1000/mm3. Patients with neutrophil counts as low as 500 cells/mm^ may be permitted if this reduction is due to the to the acute infectious process.
•Platelet count <75,000/rmn3; patients with platelet counts as low as 50,000/mm3 will be permitted if this reduction is historically stable.
•Coagulation (Prothrombin time [PT] and partial thromboplastin time [PTT]
•and/or [INR]) tests >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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method