Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06151392 |
| Other study ID # |
195 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2023 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
June 2023 |
| Source |
Ain Shams University |
| Contact |
Lobna Saad, PHD student |
| Phone |
01008006749 |
| Email |
lobnadarwish[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of the study is to evaluate the effect of non-antibiotic-based supplemental
interventions in the management of ventriculitis among pediatric patients.
The study objective is to detect the efficacy of probiotics and zinc when taken
simultaneously with antibiotic treatment as immunomodulatory in increasing the recovery rate
in pediatric population affected with ventriculitis.
Description:
Study design: A comparative, randomized, open label, controlled interventional clinical
trial.
Setting:The study will be conducted at the Neurosurgery department with the Ain Shams
University Hospitals.
Pediatric Patients admitted to the neurosurgery department according to the inclusion
criteria will be enrolled in the study and divided into four groups using simple
randomization method.
Group A: Patients administer probiotics along with the standard care of therapy for a
duration of 14 days.
Lacteol fort ® Sachets manufactured by Rameda contains Lactobacillus LB corresponding to
lactobacillus delbruekii and lactobacillus fermentum 10 billion units per sachet.
Dose: 5 billion units once or twice daily. Dosing and duration regimens were guided from
Lexicomp Online, Pediatric and Neonatal Lexi-Drugs. https://online.lexi.com. Also, from other
studies using probiotics.
Group B: Patients administering zinc supplementation along with the standard care of therapy
for the duration of 14 days.
Zn origin® 10 mg/5 mL syrup is manufactured by Egyptian Group for Pharmaceutical Industries.
For Origin International Pharma, every 100 mL syrup constituted of 0.8793 g Zn sulfate
heptahydrate which contained 0.2 g elemental Zn. Dose:
Infants <3 months: 250 mcg elemental zinc/kg/day. Infants ≥3 months: 100 mcg elemental
zinc/kg/day. Dosing and duration regimens were guided from Lexicomp Online, Pediatric and
Neonatal Lexi-Drugs. https://online.lexi.com. Also, from other studies using zinc.
Group C: Patients administering probiotics and zinc supplementation along with the standard
care of therapy for the duration of 14 days.
Group D: Patients administer only the standard care of therapy (control group). Patient data
collection
A. Demographic data:
Including age, sex, weight, height, body mass index.
B. Medication and medical history:
Including patient's medical history, past surgical history, family medical history, and
medications the patient is taking or may have recently stopped taking.
A patient's medical history may also include information about allergies, surgeries,
immunizations, health habits, such as feeding and sleeping habits.
C. Laboratory examinations The following laboratory data to be measured at baseline and after
duration of treatment period of 14 days.
1. CSF culture. Cultures and sensitivity tests from the suspected site of infection were
withdrawn from all patients at baseline. Antibiotic susceptibility was carried out using
agar diffusion and broth dilution method according to clinical and laboratory standards
institute (CLSI) guidelines.
2. CSF chemistry (protein and glucose level). Studies showed that CSF composition
comparison had higher leukocyte count in ventriculitis cases. Also, a significantly
higher CSF protein and lower CSF glucose value in ventriculitis cases.
3. C-reactive protein (CRP). measured by an immunonephelometric method. CRP is considered
an acute phase protein which is synthesized in liver in the presence of infection, it is
usually effective in the follow-up of the infection severity.
4. Procalcitonin biomarker. measured by an immunoluminometric assay. It is a 116-amino acid
prohormone and is the precursor of hormone calcitonin produced by thyroid gland under
normal conditions, the serum concentration of PCT increases significantly during
infections. It is secreted from the liver and circulating macrophages in response to
infections and could be used for the diagnosis and follow-up.
5. Complete blood picture (CBC) including TLC, RBC, Monocytes and Macrophages.
6. ESR
7. Interleukin-6
D. Signs and symptoms
Follow up the patient signs and symptoms of ventriculitis from hospital admission and during
duration of treatment. The Centers for Disease Control and Prevention's National Healthcare
Safety Network (CDC/NHSN) definition of healthcare-associated ventriculitis or meningitis
includes at least 1 of the following criteria :
Organism cultured from CSF. At least 2 of the following symptoms with no other recognized
cause in patients aged >1 year: fever >38°C or headache, meningeal signs, or cranial nerve
signs, or at least 2 of the following symptoms with no other recognized cause in patients
aged ≤1 year: fever >38°C or hypothermia a <36°C, apnea, bradycardia, or irritability and at
least 1 of the following:
- Increased white cells, elevated protein, and decreased glucose in CSF
- Organisms seen on Gram stain of CSF
- Organisms cultured from blood
- Positive nonculture diagnostic laboratory test from CSF, blood, or urine.
E. Safety and Tolerability Evaluation of the safety of probiotic supplementation and zinc in
pediatric patients with ventriculitis in terms of side effects and adverse drug events.
F. Patients' follow-up Patients will be followed up during their hospital stay through
laboratory examination at baseline and at end of study (14 days).
