Comparing Tigecycline Vs. Colistimethate in CNS Infections
NCT ID: NCT06702943
Last Updated: 2024-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
70 participants
OBSERVATIONAL
2024-12-01
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Inclusion Criteria:
Pediatric patients aged 1 month to 18 years. Presence of CNS infection symptoms such as fever, altered mental status, and positive cerebrospinal fluid (CSF) findings.
EVD placement for managing CNS infections.
Exclusion Criteria:
Known allergy to tigecycline or colistimethate sodium. Patients with concurrent severe comorbid conditions that may confound study results.
Neonates (less than 1 month old), pregnant, or breastfeeding patients.
Outcome Measures:
Primary Outcomes: Clinical cure (resolution of infection symptoms) and microbiological cure (sterilization of CSF cultures).
Secondary Outcomes: Mortality rates and adverse drug events, such as nephrotoxicity, hepatotoxicity, chemical meningitis, or seizures.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline
NCT06893835
Comparative Clinical Study Between Colistin-Tigecycline Combined Therapy Versus Colistin-Meropenem Combined Therapy in Treatment of Blood Stream Infections With Multidrug-Resistant Klebsiella Pneumoniae
NCT04489459
Study Evaluating Tigecycline Versus Ceftriaxone In Complicated Intra-Abdominal Infections & Community Acquired Pneumonia
NCT01602874
Study Evaluating Tigecycline Versus Ceftriaxone In Complicated Intra-Abdominal Infections & Community Acquired Pneumonia
NCT00914888
Antibiotic Therapy for Infectious Diseases
NCT04937894
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Central nervous system (CNS) bacterial infections, such as meningitis and ventriculitis, are severe conditions in pediatric patients, often resulting from healthcare-associated complications, invasive procedures, or the spread of infection from other body sites. Multi-drug-resistant (MDR) pathogens, particularly carbapenem-resistant Acinetobacter baumannii, pose significant challenges in treating these infections. Standard treatment options, like colistimethate sodium, are associated with limited penetration into the CNS and potential toxicity. This study compares the efficacy and safety of tigecycline, an alternative antibiotic with broad-spectrum activity, versus the standard colistimethate sodium-based regimen in managing these infections in pediatric patients.
Data Collection and Analysis:
Patient data, including demographics, clinical presentations, treatment regimens, laboratory findings (CSF analysis, cultures), and adverse effects, will be systematically collected and analyzed. The study will employ appropriate statistical tests to determine the significance of differences between the two groups.
Ethical Considerations:
Ethical approval will be obtained from the Research Ethics Committees of Ain Shams University and Cairo University. Informed consent will be obtained from the guardians of all pediatric patients. The study will ensure strict adherence to ethical guidelines, including patient confidentiality and data protection.
Expected Impact:
This study aims to provide crucial data on the effectiveness and safety of alternative antibiotic regimens for pediatric CNS infections, potentially guiding clinical practice and improving outcomes for children affected by these severe infections in Egypt and globally.
Study Design:
A prospective observational clinical trial conducted on Pediatrics at Cairo University Hospitals, Egypt.
Study Population:
A total of 70 pediatric patients, aged 1 month to 18 years, admitted with confirmed or suspected CNS infections and with an external ventricular drain (EVD) in place.
Patient Groups:
Intervention Group (n = 35): Pediatric patients receiving a tigecycline-based regimen administered both intravenously (IV) and intraventricularly (IVT) for 14-21 days.
Control Group (n = 35): Pediatric patients receiving a colistimethate sodium-based regimen (standard therapy for MDR infections) administered both IV and IVT for 14-21 days.
Data Collection and Analysis:
Patient data, including demographics, clinical presentations, treatment regimens, laboratory findings (CSF analysis, cultures), and adverse effects, will be systematically collected and analyzed. The study will employ appropriate statistical tests to determine the significance of differences between the two groups.
Ethical Considerations:
Ethical approval will be obtained from the Research Ethics Committees of Ain Shams University and Cairo University. Informed consent will be obtained from the guardians of all pediatric patients. The study will ensure strict adherence to ethical guidelines, including patient confidentiality and data protection.
Expected Impact:
This study aims to provide crucial data on the effectiveness and safety of alternative antibiotic regimens for pediatric CNS infections, potentially guiding clinical practice and improving outcomes for children affected by these severe infections in Egypt and globally.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pediatrics patients having EVD and suffering from meningitis caused by MDR bacteria
Tigecycline (Tygacil)
tigecycline-based regimen administered both intravenously (IV) and intraventricularly (IVT) for 14-21 days
Colistimethate sodium (CMS)
Colistimethate sodium-based regimen (standard therapy for MDR infections) administered both IV and IVT for 14-21 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tigecycline (Tygacil)
tigecycline-based regimen administered both intravenously (IV) and intraventricularly (IVT) for 14-21 days
Colistimethate sodium (CMS)
Colistimethate sodium-based regimen (standard therapy for MDR infections) administered both IV and IVT for 14-21 days.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Presence of CNS infection symptoms such as fever, altered mental status, and positive cerebrospinal fluid (CSF) findings.
* EVD placement for managing CNS infections.
Exclusion Criteria
Neonates (less than 1 month old).
28 Days
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ain Shams University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ACUC-FP-ASU#265
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.