Central Nervous System InfectionsNCT06702943
Comparing Tigecycline Vs. Colistimethate in CNS Infections
An observational study of Central Nervous System Infections, run by Ain Shams University.
Trial summary
This observational 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. Inclusion Criteria: Pediatric patients aged 1 month to 18 years. Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Central Nervous System Infections
- What is being tested?
- Tigecycline (Tygacil) and Colistimethate sodium (CMS)
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Known allergy to tigecycline or colistimethate sodium. Patients with concurrent severe comorbid conditions that may confound study results.
- Neonates (less than 1 month old).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Study of the Efficacy and Safety of Tigecycline Based Regimen Versus Colistimethate Sodium-based Regimen in Patients with Central Nervous System Bacterial Infections
This observational 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.
Inclusion Criteria:
Read more
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.
Read the detailed description
Background:
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
- Central Nervous System Infections
- Being tested
- Tigecycline (Tygacil), Colistimethate sodium (CMS)
- Keywords
- Central nervous system infections, MDR bacteria
- Medical subject headings
- Central Nervous System Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tigecycline (Tygacil)Drug
tigecycline-based regimen administered both intravenously (IV) and intraventricularly (IVT) for 14-21 days
Colistimethate sodium (CMS)Drug
Colistimethate sodium-based regimen (standard therapy for MDR infections) administered both IV and IVT for 14-21 days.
| Study group | Role | What they receive |
|---|---|---|
| Pediatrics patients having EVD and suffering from meningitis caused by MDR bacteria | Not described Receives: Drug: Tigecycline (Tygacil); Drug: Colistimethate sodium (CMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological eradication
CSF Culture: Conducted at diagnosis and follow up for it till the end of the treatment course to monitor microbiological clearance. Two consecutive negative cultures are required to consider positive microbiological eradication.
Measured: follow up of the patients from time of enrollment to end of treatment is for 14-21 days
Clinical Cure rate
Resolution of infection symptoms like fever, seizures, fatigue and neck stiffness.
Measured: follow up of the patients from time of enrollment to end of treatment is for 14-21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System InfectionsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702943
- Sponsor's protocol ID
- ACUC-FP-ASU#265
- Status last verified
- Jun 2024
- First submitted
- 10 Sep 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Efficacy and Safety of Tigecycline Based Regimen Versus Colistimethate Sodium-based Regimen in Patients with Central Nervous System Bacterial Infections
- ClinicalTrials.gov ID
- NCT06702943
- Acronym / sponsor ID
- ACUC-FP-ASU#265
- Conditions
- Central Nervous System Infections
- Keywords
- Central nervous system infections, MDR bacteria
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational 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.
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.
Detailed description
Background:
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatrics patients having EVD and suffering from meningitis caused by MDR bacteria | – | Drug: Tigecycline (Tygacil), Drug: Colistimethate sodium (CMS) |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Known allergy to tigecycline or colistimethate sodium. Patients with concurrent severe comorbid conditions that may confound study results.
- Neonates (less than 1 month old).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tigecycline (Tygacil)tigecycline-based regimen administered both intravenously (IV) and intraventricularly (IVT) for 14-21 days | Drug | Pediatrics patients having EVD and suffering from meningitis caused by MDR bacteria |
| Colistimethate sodium (CMS)Colistimethate sodium-based regimen (standard therapy for MDR infections) administered both IV and IVT for 14-21 days. | Drug | Pediatrics patients having EVD and suffering from meningitis caused by MDR bacteria |
Primary outcome
Microbiological eradication
Time frame: follow up of the patients from time of enrollment to end of treatment is for 14-21 days
CSF Culture: Conducted at diagnosis and follow up for it till the end of the treatment course to monitor microbiological clearance. Two consecutive negative cultures are required to consider positive microbiological eradication.
Clinical Cure rate
Time frame: follow up of the patients from time of enrollment to end of treatment is for 14-21 days
Resolution of infection symptoms like fever, seizures, fatigue and neck stiffness.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Nervous System Infections, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelwahab, MSc (+20-1224959630, Nouran_elsherazy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological eradication (time frame: follow up of the patients from time of enrollment to end of treatment is for 14-21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.