Comparison of Efficacy of Oral Amoxicillin Versus Intravenous Ceftriaxone

NCT06532409 | Not Yet Recruiting

• 1 other identifier: DrAsimCHL
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The efficacy of oral amoxicillin is considered equal to that of ceftriaxone in community-acquired pneumonia among children. Also, there are some factors that contradict the usage of ceftriaxone, like antibiotic resistance, adverse reactions, drug cost, and the and the chances of IV trauma and infection, which is a major problem in developing countries. Therefore, this study was planned to determine the efficacy of oral amoxicillin compared with intravenous (IV) ceftriaxone in the treatment of uncomplicated ceftriaxone in community acquired pneumonia in children less than 5 years of age.

Conditions

Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• Free from fever

  Efficacy will be labeled yes where fever symptoms are resolved (temperature = 98.6ºF) within 3 days.

  3 days

Study Arms (2)

Oral Amoxicillin

EXPERIMENTAL

Patients in this group will receive IV amoxicillin/CA at a dose of 100 mg per kg per day in 3 divided doses for a maximum period of 7 days.

Drug: Amoxicillin/CA

IV Ceftriaxone

EXPERIMENTAL

Patients in this group will receive IV ceftriaxone at a dose of 75 mg per kg per day in 2 divided doses for a maximum period of 7 days.

Drug: IV ceftriaxone

Interventions

Amoxicillin/CA DRUG

Patients will receive IV amoxicillin/CA at a dose of 100 mg per kg per day in 3 divided doses for a maximum period of 7 days.

Oral Amoxicillin

IV ceftriaxone DRUG

Patients will receive IV ceftriaxone at a dose of 75 mg per kg per day in 2 divided doses for a maximum period of 7 days.

IV Ceftriaxone

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of both gender
• Aged from 2 to 5 years
• With fever \>37.5 C (99.5 F)
• Will be presented with symptoms and signs of uncomplicated community acquired pneumonia

You may not qualify if:

• Children requiring ICU care (having cyanosis SpO2 \< 85% requiring intubation within first day of admission or in state of shock)
• Children with conditions like congenital heart disease, chronic lung disease, chronic kidney disease, severe malnutrition, asthma, foreign bodies, sickle cell disease, and immunodeficiency
• Children with underlying anatomical disorders of the lung like pulmonary sequestration, tracheoesophageal fistula or congenital cystic adenoid malformation
• Children already on antibiotics
• Presence of any complication of community acquired pneumonia
• Patients having symptoms of multi-organ involvement/sepsis
• Hypersensitivity to Amoxicillin or Ceftriaxone
• Other co-existing infections like dengue, malaria, or measles

Sponsors & Collaborators

• RESnTEC, Institute of Research: lead

Study Sites (1)

Children Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Ceftriaxone

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Asim Din, FCPS

CONTACT

+923360017562; asimdin@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: October 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)