.A.

Not Applicable

• Conditions: -J18; J18

• Registration Number: PER-006-98
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1998-06-11
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

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 <4,500/min3.
2) Radiographic Criteria: within 48 hours of the institution 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.
3) Microbiological Criteria: a) Within 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 endobronchial lavage or protected-brush sampling, transtracheal aspiration, percutaneous lung or pleural fluid aspiration. The sample should be sent to the site´s microbiology laboratory for the following tests: Gram stain, culture, and susceptibility testing, b) Microscopic examination of the Gram-stained respiratory secretions should show presence of microorganisms, >25 polymorphonuclear cells and <10 squamous epithelial cells/field at 100 times magnification (low-power, 10 times objective). Only appropriate specimens should be cultured, and c) Blood culture and susceptibility testing should be done in all patients.
-Age >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

-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 <25%; or Hemoglobin <8 g/dL.
-Neutropenia with absolute neutrophil count (ANC),1000/mm3. Patients with ANC <500/nim3 may be enrolled if this is directly related to the acute infection.
-Platelet count <75,000/nim3; patients with platelet counts as low as 50,000/rmn3 may be enrolled if this value 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.
-Presence of renal or hepatic disease: 1) Serum creatinine >2.0 times ULN in patients <65 years of age, or >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified