NCT07317440

Brief Summary

The aim of this work is to assess the benefit of coenzyme Q10 supplementation, in addition to standard antibiotic and other supportive therapy, in the management of hospitalized children with community acquired pneumonia

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

June 9, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

December 31, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

June 9, 2025

Last Update Submit

December 18, 2025

Conditions

Outcome Measures

Primary Outcomes (10)

  • Normalization of respiratory rate

    3 days

  • Normalization of temperature

    3 days

  • Normalization of oxygen saturation

    3 days

  • Normalization of Feeding Behavior Assessed by Oral Intake Tolerance

    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

    Blood samples will be collected, and CRP concentration will be expressed in milligrams per liter (mg/L).

    5 days

  • Serum Lactate Dehydrogenase (LDH) Level

    LDH concentration will be reported in units per liter (U/L) from venous blood samples.

    5 days

  • Prognostic Nutritional Index

    5 days

  • Systemic Immune-Inflammation Index

    5 days

  • Serum C-Reactive Protein to Albumin Ratio (CRP/Albumin Ratio)

    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

    3-5 days

Secondary Outcomes (2)

  • Length of hospital stay

    10-21 days

  • Number of Participants Requiring Surgical Intervention

    21-30 days

Study Arms (2)

60 children with community acquired pneumonia will receive oral coenzymeQ10

EXPERIMENTAL
Drug: oral coenzymeQ10

60 children with community acquired pneumonia with the standard pneumonia treatment.

NO INTERVENTION

Interventions

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.

60 children with community acquired pneumonia will receive oral coenzymeQ10

Eligibility Criteria

Age2 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 37515, Egypt

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Central Study Contacts

Ahmed Elniny Lecturer of Pediatrics, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of pediatrics

Study Record Dates

First Submitted

June 9, 2025

First Posted

January 5, 2026

Study Start

December 31, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations