None listed
Conditions
Interventions
MK-0826 initially as a single daily dose of 1 g I.V. (infused over a 30-minute interval) plus placebo to ceftriaxone sodium.
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: 1) Clinical Criteria: New onset of a clinical picture compatible with bacterial pneumonia with at least TWO of the following signs and symptoms: a) Cough, b) Production of purulent sputum or an increase or a change in the character of, c) 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),d) Dyspnea, tachypnea, hypoxemia, pleuritic chest pain, particularly if any or all of these are progressive in nature, e) Organism consistent with a respiratory pathogen isolated from blood culture, AND at least ONE of the following: f) Fever, defined as body temperature >38°C (100.4°F) orally, >38.5°C (101.2°F) tympanically, or >39°C (102.2°F) rectally, chills, g) An elevated total peripheral WBC >10,000/mm3, or >15% immature neutrophils (bands), regardless of total peripheral WBC, or leukopenia with total WBC 25 polymorphonuclear cells and 18 Years (Males and Females are Eligible). For patients <40 years of age, enrollment is permitted provided there is substantial evidence that the causative pathogen is a typical pyogenic lower respiratory tract pathogen. Such evidence would include: 1) Demonstration of a predominant pathogen in Gram-stained specimen of sputum or other respiratory tract secretion, or 2) A positive blood culture for a respiratory pathogen in the setting of a compatible clinical syndrome with appropriate radiologic findings. Females of childbearing potential must have a negative serum pregnancy test (p-HCG) prior to enrollment into the study, and subsequently, until one month after the last dose of study medications, use adequate birth control measures as discussed with the investigator. Hormonal contraceptives should not be used as the sole method of birth control because of the effect of MK-0826 on the efficacy of hormonal contraceptives has not yet been establishe
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 (non-urticarial) rash to penicillins or other b-lactams may be enrolled. - History of allergy, hypersensitivity, intolerance, or any other adverse reaction to an 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. - Patients who have sepsis syndrome with acute hemodynamic instability (such as a requirement of pressors) or adult respiratory distress syndrome should be excluded. The requirement of volume repletion (but not pressors) for support of blood pressure and the need for mechanical ventilation for patients with severe pneumonia is allowed. - Patients considered to be at increased risk for meningitis (since the penetration of MK-0826 into CSF has not yet been determined). - Patients hospitalized or in other long-term care facility (such as nursing homes) for >48 hours before onset of pneumonia (hospital-acquired pneumonia). - Patients on mechanical ventilation prior to onset of pneumonia (ventilator associated pneumonia), - 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—this requires that pre-study respiratory or blood cultures are positive). - 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 prior history of tuberculosis and who: (1) are currently on therapy, or (2) have active untreated tuberculosis, or (3) have a positive Acid Fast Bacilli (AFB) smear. - Hematocrit 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. - Presence of renal or hepatic disease: 1) Serum creatinine >2.0 times ULN in patients 1.5 times ULN for patients over 65 years of age, 2) Liver function tests: a. ALT, AST >6 times ULN values used by the laboratory performing the test. Patients with elevations of AST and/or ALT up to 10 times ULN will be allowed if these elevations are acute and directly related to the infectious process being treated. This should be documented, b. Bilirubin >3.0 times ULN, unless isolated hyperbilinibinemi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The proportion of patients who have both a favourable clinical response assessment at the early follow-up visit. Measure:Primary clinical effectiveness criteria Timepoints:7 to 14 days after discontinuation of all antibiotic therapy ; Outcome name:The primary safety variable will be the proportion of patients within each treatment group that experiences one or more drug-related adverse events. Measure:Primary safety criteria Timepoints:Throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The proportion of patients without documented PRSP who have a favourable clinical response assessment at the late follow-up visit. Measure:Secondary clinical effectiveness criteria Timepoints:21 to 28 days after discontinuation of all antibiotic therapy ; Outcome name:The proportion of patients without documented PRSP who have both a favourable clinical and microbiological response assessment at the early and late follow-up visit. Measure:Secondary clinical and microbiological effectiveness criteria Timepoints:7 to 14, 21 to 28 days after discontinuation of all antibiotic therapy ; Outcome name:The proportion of patients with documented PRSP who have both a favourable clinical and microbiological response assessment at the early and late follow-up visit. Measure:Secondary clinical and microbiological effectiveness criteria Timepoints:7 to 14, 21 to 28 days after discontinuation of all antibiotic therapy | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed