The Role of Melatonin as an Adjuvant Therapy in Childhood Pneumonia

NCT06949904 | Recruiting Phase 1 DMC

• 1 other identifier: F.1-1/2015/ERB/SZABMU/1186
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to compare the mean length of hospital stay between children with pneumonia receiving melatonin as an adjuvant therapy and those receiving standard of care alone. The hypothesis is that combining oral melatonin with standard treatment can reduce the length of hospital stay as compared to standard of care alone. The control group will receive standard treatment (antibiotic) while the intervention group will receive standard treatment plus melatonin for 14 days.

Conditions

Pneumonia Childhood

Keywords

Pneumonia; Childhood pneumonia; Melatonin

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  The primary outcome is the length of hospital stay, measured in days, from admission to discharge. The mean and standard deviation of hospital stay will be calculated for both groups (melatonin and non-melatonin) and compared using an independent sample t-test.

  14 days

Study Arms (2)

Standard Treatment

NO INTERVENTION

Standard treatment - Antibiotic such as ampicillin in a dose of 50mg//kg/dose x TDS

Adjuvant Therapy

EXPERIMENTAL

Standard Treatment along with Melatonin @ 1 mg/dose in infants and 2.5 to 3mg/dose in children three times a day for 14 days

Drug: Melatonin

Interventions

Melatonin DRUG

1 mg/dose in infants and 2.5 to 3mg/dose in children three times a day for 14 days

Adjuvant Therapy

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• month to 12 years
• Both genders
• Patient diagnosed as having pneumonia or severe pneumonia according to WHO definition

You may not qualify if:

• Hospitalized within 14 days prior to the study
• Known TB exposure
• Active varicella or herpes simplex infection
• Allergy to the study medication
• Currently taking melatonin
• Any non pneumonia acute medical illness which requires antibiotic treatment as per local standard of care
• Galactose intolerance, the lapp-lactase deficiency or glucose-galactose malabsorption
• Significant co-morbid disease: lung, cardiac, immune, liver, endocrine, neurological or psychiatric

Sponsors & Collaborators

• Mian Muhammad Hassan Ahmed: lead

Study Sites (1)

Pakistan Institute of Medical Sciences

Islamabad, Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Pneumonia

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Post Graduate Resident

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 29, 2025
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

PA (1)