A Study the Population Pharmacokinetics of Children of Infectious Disease in Central Nervous System

NCT03960905 | Unknown

• 1 other identifier: 2019-CNSI-001
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to study the population pharmacokinetics of children receiving the anti-infective drugs for treatment of infectious disease in central nervous system.

Conditions

Central Nervous System Infection

Outcome Measures

Primary Outcomes (1)

• maximum concentration (Cmax)

  Cmax is a term used in pharmacokinetics refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose.

  up to 4 weeks

Secondary Outcomes (1)

• time to achieve maximum concentration (Tmax)

  up to 4 weeks

Study Arms (1)

Children with the usage of anti-infective drugs

in conformity with the clinical practice

Other: Children with the usage of anti-infective drugs

Interventions

Children with the usage of anti-infective drugs OTHER

According to the models of population pharmacokinetics,the investigators and want to correlate use of antibiotics with treatment effectiveness and safety in children.

Also known as: Cefepime (Maxipime®), ceftazidime, meropenem (Mepem®)

Children with the usage of anti-infective drugs

Eligibility Criteria

• Age: 29 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children with infections of center nurous system therapies.

You may qualify if:

• Children (29 days-18 years old) with anti-infective therapy against infectious disease in central nervous system.
• Clinical symptoms: acute onset, fever (axillary temperature 38 ℃ or higher), headache, altered level of consciousness, vomiting, irritability, sleepiness, low muscle tone, seizures, before the fontanelle full or uplift, positive meningeal stimulation;
• Aboratory examination: CSF appearance change, CSF routine WBC \>100 per ml, CSF routine WBC 10-100 per ml, glucose \<40mg/dl, protein \>100mg/dl), positive detection of etiology (bacterial culture, antigen detection, gram staining).

You may not qualify if:

• autoimmune encephalitis;
• central nervous system infection complicated with tumor;
• allergic to carbapenems or glycopeptide antibiotics;
• other cases not suitable for enrollment (small sample size, incomplete clinical data, etc.).

Sponsors & Collaborators

• Wei Zhao: lead
• Beijing Children's Hospital: collaborator

Study Sites (1)

Department of Infectious Diseases, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health

Beijing, Beijing Municipality, 100045, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma and hemocyte

MeSH Terms

Conditions

Central Nervous System Infections

Interventions

Cefepime; Ceftazidime; Meropenem

Condition Hierarchy (Ancestors)

Infections; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cephaloridine; Thienamycins; Carbapenems

Central Study Contacts

Zhao Wei, Ph.D

CONTACT

053188383308; zhao4wei2@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor; Head of department of clinical pharmacy and pharmacology

Study Record Dates

• First Submitted: April 27, 2019
• First Posted: May 23, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 23, 2019

Record last verified: 2019-05

Locations

CN (1)