None listed
Conditions
Interventions
Group 1 Type of group
20 mg / kg IV of MK-0826 for 6 months
Group name:Group 2 Type of group
40 mg / kg IV of MK-0826 for 6 months
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient is> 3 months to 500 leukocytes / mm, neutrophils> 80%) and elevated CSF protein (> 60 mg / dL) and low CSF glucose (<30 mg / dL). • The patient´s clinical results are consistent with meningitis. Among these results, it could include: o Fever, drowsiness and / or change in mental status or Headache, stiff neck and / or positive signs of Kemig or Brudzinski. o Lethargy, confusion or coma. o There are no contraindications for the administration of MK-0826 within 48 hours from the original lumbar puncture. o The relative or custodian knows the procedures and agrees on the patient´s participation through a written informed consent o The patient is not overweight or is underweight for his age (between the 3rd and 97th percentile of weight by age). o Except for meningitis that requires treatment with intravenous antibiotics, the patient is considered to have no significant organic dysfunctions based on medical history, physical examination and laboratory safety tests.
Exclusion criteria
Exclusion criteria: • The patient is 17 years of age (at the time of administration of the medication). • The patient does not have bacterial meningitis or meningitis associated with the following: o Foreign bodies in the CNS (including resident catheters, ventricular peritoneal shunts, or intracranial pressure monitors). o Neurosurgical procedures in the previous 3 months o Craniofacial trauma in the previous 3 months. Congenital or anatomical defects with predisposition to CNS infections o Mycobacterial, viral, fungal meningitis and parasitic meningitis. • The patient is in a situation (for example, care in an unreliable home) or has a condition in which, in the opinion of the investigator, it may interfere with optimal participation in the study. • The patient has a history of drug addiction or alcoholism or is a recreational user of illegal drugs. • The patient has a history of cardiac or vascular disorders, asthma or some other lung disease, gastrointestinal irregularities / peptic ulcer, or neurological, hematologic (including blood disorder) endocrine, renal (as defined by abnormal serum creatinine) or diseases Genitourinary serious. • Protocol / Amendment No .: 032-01 • The patient has a hemoglobin of more than 1 g / dL below the normal limit of age, absolute neutrophil count 1.5 times normal, ALT or AST> 2.5 normal or creatinine times> 1.5 times normal. • The patient is unstable from the hemodynamic point of view or shows a compromised hemodynamic situation. • The patient has participated in other clinical tests within 4 weeks prior to the administration of MK-0826. • The patient has a history of multiple and / or severe allergies to medications or food or major clinical intolerance or allergy to the antibiotics Plactamics (cephalosporins, penicillins, and carbapenems). • The patient has a history of psychiatric disorders. • The patient has significant abnormalities in clinical pre-test or laboratory safety tests that could affect both patient safety and confuse the interpretation of the study (as decided by consensus by the Merck clinical monitor or investigator). • The patient has a history of diseases that, in the opinion of the investigator, may confuse the results of the study or add risk to the administration of the medication to the patient. • The patient has had a seizure (other than a previous untreated febrile seizure without complications). • Concomitant use of medications that may potentially affect the pharmacokinetics of MK-0826 (eg, high-protein-binding drugs or drugs that compete with tubular secretion, including, but not limited to, probenecid, penicillins, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Cerebrospinal fluid test Measure:Concentrations on spinal fluid of MK-0826 after a single intravenous dose of 40-mg / kg in children and adolescents with meningitis in ages between> 3 months to <17 years to 12 hours after administration. Timepoints:12 hours after each dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Cerebrospinal fluid test Measure:MK-0826 LCR at 12 hours after the administration of a single intravenous dose of 20 mg / kg Timepoints:12 hours after the administration of a single intravenous dose of 20 mg / kg ; Outcome name:Cerebrospinal fluid test Measure:Maximum concentration of MK-0826 Timepoints:Until there is no variation in MK-0826 concentration on the cerebrospinal fluid. ; Outcome name:Vital signs and laboratory tests will be evaluated Measure:Incidence of any adverse event during the study Timepoints:During the whole study | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed