- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07317440
Coenzyme Q10 in Pediatric Community-Acquired Pneumonia
Coenzyme Q10 as an Adjunct Therapy in Pediatric Community-Acquired Pneumonia
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed Elniny Lecturer of Pediatrics, MD
- Phone Number: 01002219783
- Email: Ahmedelniny8@gmail.com
Study Locations
-
-
Gharbia Governorate
-
Tanta, Gharbia Governorate, Egypt, 37515
- Tanta University
-
Contact:
- Rehab Zaki Elmeazawy
- Phone Number: 01004815280
-
Contact:
- Email: Ahmedelniny8@gmail.com
-
Principal Investigator:
- Rehab Zaki Elmeazawy, MD
-
Sub-Investigator:
- Ahmed Elniny Ahmedelniny8@gmail.com, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All children aged 2 months -18 years with community acquired pneumonia diagnosed by signs and symptoms of CAP including; chest pain, dyspnea, tachypnea, or abnormal auscultatory findings plus focal findings on chest x ray indicating community acquired pneumonia
Exclusion Criteria:
- Children with immunodeficiency, chronic lung disease, malignancy, congenital lung anomalies, underlying disorder impacting respiration i.e. genetic, metabolic, neuromuscular disorders, children with CHD affecting the pulmonary blood flow.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 60 children with community acquired pneumonia will receive oral coenzymeQ10
|
60 children with community acquired pneumonia will receive oral coenzymeQ10 in capsule form at a dose of 100-200 mg/kg/day, as adjunct therapy to the usual pneumonia treatment till the recovery of the disease.
|
|
No Intervention: 60 children with community acquired pneumonia with the standard pneumonia treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Normalization of respiratory rate
Time Frame: 3 days
|
3 days
|
|
|
Normalization of temperature
Time Frame: 3 days
|
3 days
|
|
|
Normalization of oxygen saturation
Time Frame: 3 days
|
3 days
|
|
|
Normalization of Feeding Behavior Assessed by Oral Intake Tolerance
Time Frame: 3 days
|
Normalization of feeding refusal will be assessed by evaluating the child's ability to tolerate age-appropriate oral feeding without refusal over a 3-day observation period.
|
3 days
|
|
Serum C-Reactive Protein (CRP) Level
Time Frame: 5 days
|
Blood samples will be collected, and CRP concentration will be expressed in milligrams per liter (mg/L).
|
5 days
|
|
Serum Lactate Dehydrogenase (LDH) Level
Time Frame: 5 days
|
LDH concentration will be reported in units per liter (U/L) from venous blood samples.
|
5 days
|
|
Prognostic Nutritional Index
Time Frame: 5 days
|
5 days
|
|
|
Systemic Immune-Inflammation Index
Time Frame: 5 days
|
5 days
|
|
|
Serum C-Reactive Protein to Albumin Ratio (CRP/Albumin Ratio)
Time Frame: 5 days
|
The serum C-reactive protein to albumin ratio (CRP/albumin ratio) will be calculated as a single composite outcome measure using laboratory values obtained from the same blood sample.
|
5 days
|
|
Time of clinical stability
Time Frame: 3-5 days
|
3-5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of hospital stay
Time Frame: 10-21 days
|
10-21 days
|
|
|
Number of Participants Requiring Surgical Intervention
Time Frame: 21-30 days
|
This outcome measures whether a participant undergoes any surgical intervention related to the study condition during the follow-up period. Surgical intervention is defined as any operative procedure performed under general or regional anesthesia, as documented in the medical record. The outcome will be recorded as a binary variable (Yes/No) for each participant and summarized as the number and proportion of participants requiring surgical intervention. |
21-30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36264PR1169/3/25
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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