INTRAVENOUS DOSE OF MK-0826 OPEN STUDY TO EVALUATE THE PROFILES OF PLASMA CONCENTRATION OF THIS DRUG IN PATIENTS FROM 3 MONTHS TO 17 YEARS OLD
- Conditions
- -A499 Bacterial infection, unspecifiedBacterial infection, unspecifiedA499
- Registration Number
- PER-007-01
- 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
• The patient is between 3 months and 17 years of age. Patients of childbearing age should demonstrate a level of b-hCG in urine consistent with the absence of pregnancy at the pre-study visit and agree to remain abstinent or use the double-barrier method of contraception for at least 14 days prior to Pre-study visit, throughout the period and for at least 14 days after the last dose of the study drug.
• The patient is hospitalized, is clinically stable and requires intravenous therapy.
• The parent or guardian understands the procedures and accepts the patient´s participation by providing written informed consent.
• The patient is not overweight or underweight for his age (between the 3rd and 97th percentile of weight for age).
• Except for an infection that requires treatment with antibiotics applied intravenously, it is considered that the patient is otherwise healthy and does not have a condition that could affect the interpretation of pharmacokinetic or safety information.
• The patient is less than 3 months or more than 17 years old (at the time of administration of the drug).
• In the opinion of the investigator, the patient is mentally incapacitated.
• The patient is in a situation or has a condition that, at the discretion of the investigator, may interfere with optimal participation in the study.
• The patient has a history of having abused drugs and / or alcohol or is currently a recreational consumer of illicit drugs.
• The patient has not had seizures for <2 years if he or she is receiving treatment or has not had seizures for <1 if he or she does not receive treatment.
• The patient has a history of CNS infection.
• It has been confirmed or there are suspicions that the patient suffers an infection of the central nervous system.
• The patient is unstable from the hemodynamic point of view or has a hemodynamic compromise.
• Currently, the patient is receiving therapy with ceftriaxone under a daily regimen of twice a day.
• The patient has participated in another study (which includes drugs approved by the FDA for an indication not approved by the FDA) of a research agent during the last 4 weeks.
• The patient has a history of multiple and / or severe allergies to drugs or foods or a history of intolerance or allergy to 13-lactam antibiotics (cephalosporins, penicillins, carbapenems).
• The patient has a history of psychiatric disorders.
• The patient has a history of Cystic Fibrosis.
• The patient presents clinically significant abnormalities in the pre-study clinical examination or the laboratory safety tests (outside the normal range for the age) that could affect the safety of the patient or confuse the interpretation of the study (according to the determination by consensus decision of the monitor and clinical researcher of Merck).
• The patient has a history of a disease that, in the opinion of the investigator, could confuse the results of the study or represent an additional risk in the administration of the study drug to the patient.
• Concomitant use of drugs that can potentially affect the pharmacokinetics of MK-0826 (eg, drugs highly bound to proteins or drugs competing for tubular secretion, including, but not limited to, probenecid, cefoperazone, itraconazole, phenytoin, valproic acid , nafcillin, diazepam or warfarin) or the subsequent interpretation of the study results should be discussed with the Merck clinical monitor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method